ORIGINAL ARTICLE Year : 2022  |  Volume : 11  |  Issue : 3  |  Page : 66-70

A clinical trial of comparing dexmedetomidine and remifentanil on the oximetry parameters in the patients with end-stage renal disease undergoing arteriovenous fistula formation

Reza Mahmoud Mohaghegh Dolatabadi1, Soudabeh Djalali Motlagh2, Mohamadreza Ghodraty2, Amineh Shafeinia3, Alireza Maleki4, Zeinab Norouzi5, Shiva Khaleghparast6
1 Department of Anesthesiology, Hasheminejad Hospital, Iran University of Medical Sciences, Tehran, Iran
2 Department of Anesthesiology, Firoozgar General Hospital, Iran University of Medical Sciences, Tehran, Iran
3 Department of Anesthesiology, Akbarabadi Hospital, Iran University of Medical Sciences, Tehran, Iran
4 Department of Anesthesiology, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran, Iran
5 Department of Cardiac Rehabilitation, Rajaie Cardiovascular and Research Center, Tehran, Iran
6 Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran

Date of Submission19-Feb-2022Date of Decision06-Jun-2022Date of Acceptance07-Jun-2022Date of Web Publication11-Oct-2022

Correspondence Address:
Dr. Alireza Maleki
Department of Anesthesiology, Rasoul Akram Hospital, Iran University of Medical Sciences, Tehran
Iran

Source of Support: None, Conflict of Interest: None

DOI: 10.4103/rcm.rcm_12_22

Background: Oximetry is a method for measuring the arterial hemoglobin saturation (SpO2) using pulse oximeter and is essential in any type of anesthetic procedures. The growing population of geriatrics in the recent decades in combination with an increase in the prevalence of chronic diseases including diabetes and hypertension are some of the leading causes for an increase in the prevalence of chronic kidney disease and end-stage renal disease (ESRD). The definite treatment for ESRD is renal transplant but unfortunately, it may take a long time to find a suitable kidney and continuing the patient's life may depend on dialysis. Arteriovenous fistula (AVF) formation is one of the first steps to prepare the patient for hemodialysis. ESRD itself is a reason for physical and psychosocial issues. Preparing a favorable condition for AVF surgery is essential to decrease the burden of the underlying disease. An efficient respiratory supply is necessary in all parts of an anesthetic procedures. Aims and Objectives: This study is a double-blind clinical trial to compare two anesthetic agents, dexmedetomidine and remifentanil in patients with ESRD who underwent AVF formation. Materials and Methods: SpO2 was measured on different phases including the time of initial incision, and after 10, 30, 60, 90, and 120 min of finishing the surgery. The data were analyzed using SPSS version 22, two-way repeated measures (ANOVA), and independent t-test. Results: This study showed that there was no any significant difference in using any of these two agents with regard to SpO2 in the different times of measurements during the anesthetic procedure and after the surgery in the recovery phase. Conclusion: This study showed that there is not any superiority in using DEX or REM in the patients undergo AVF formation. More studies on the other groups of the patients with different surgeries.

Keywords: Arteriovenous fistula, dexmedetomidine, end-stage renal disease, oximetry, remifentanil

How to cite this article:
Dolatabadi RM, Motlagh SD, Ghodraty M, Shafeinia A, Maleki A, Norouzi Z, Khaleghparast S. A clinical trial of comparing dexmedetomidine and remifentanil on the oximetry parameters in the patients with end-stage renal disease undergoing arteriovenous fistula formation. Res Cardiovasc Med 2022;11:66-70
How to cite this URL:
Dolatabadi RM, Motlagh SD, Ghodraty M, Shafeinia A, Maleki A, Norouzi Z, Khaleghparast S. A clinical trial of comparing dexmedetomidine and remifentanil on the oximetry parameters in the patients with end-stage renal disease undergoing arteriovenous fistula formation. Res Cardiovasc Med [serial online] 2022 [cited 2022 Oct 12];11:66-70. Available from: https://www.rcvmonline.com/text.asp?2022/11/3/66/358228   Introduction 

Oximetry is used for evaluating the blood oxygen status and pulse oximeter is a noninvasive tool for measuring the blood oxygen saturation.[1],[2] The basic function of the pulse oximeter is a spectrometry for quantification of arterial hemoglobin saturation (SpO2).[3],[4],[5],[6],[7] Pulse oximetry is one of the essential parts for the patients' care in anesthesia.[8] The first pulse oximeter was created in 1935 by Matthes for evaluating the blood oxygen constantly,[9] and after developing the first version by the other researchers, it was used in the operating room by Earl Wood in the late 1940s for the first time.[10] It was used by Glenn Allen Millikan during world War II to evaluate the piolets' O2 saturation (SaO2) during the flightes.[11] Then, the scientists found that the clinical presentations of patients with cyanosis are not reliable[12] due to severe anemia or skin pigmentation.[13] Furthermore, the symptoms of hypoxia are detected when the SaO2 is lower than 80%.[12] Pulse oximetry is a useful measurement for the early diagnosis of cyanosis.[14] In 1974, Aoyagi et al. made a type of pulse oximeter with the combination of photoplethysmography and oximetry in a single tool.[15] Since the early years of the 1980 decade, pulse oximetry was widely used in the clinical fields.[16] According to the recommendations of the American Society of Anesthesiologists, pulse oximetry is a part of basic standard care in the operating room.[17] Pulse oximetry is perhaps the most important measurement tool to show valuable data including heart rate and SaO2.[18] It is used to evaluate the peripheral oxygen supply and is indicated in all of the patients, especially in the geriatrics.[19] According to the aging of the population, the prevalence of chronic diseases is increasing.[20] Chronic kidney disease (CKD) is not only a consequence of aging but also is a complication of other chronic diseases including hypertension and diabetes mellitus.[21],[22] Furthermore, with increasing in the elderly population in the world, increasing the prevalence of CKD is not surprising.[23] The definite treatment for end-stage renal disease (ESRD) is kidney transplant, but it is not available for a huge population of patients for a long time, and continuing the life in these patients is dependent to dialysis.[24],[25] Arteriovenous fistula (AVF) formation is the first step of hemodialysis in ESRD patients and physical and psychological problems may happen in most of these patients.[26],[27],[28] A favorable anesthesia can reduce the mentioned burden in the patients significantly and using appropriate agents plays an important role to achieve to this purpose. Dexmedetomidine (DEX) is a selective agonist of the α-2 adrenoceptor without the effect of respiratory depression.[29] Remifentanil (REM) is an agonist of μ-opioid receptor and is known as an approximately safe agent for patients with CKD.[30]

Aim

In this study, the effect of the two anesthetic agents including DEX and REM on the oximetry parameters is compared to each other in the patients with ESRD who underwent AVF formation.

  Methods 

It is a double-blind clinical trial. In this study based on the formula, 40 patients with ESRD were enrolled. The inclusion criteria were being a candidate for AVF formation, the age of 19–80 years old and being in a stable hemodynamic on the admission. The exclusion criteria were the positive history for the chronic diseases including cardiovascular diseases, hepatic failure, history of allergic reaction to any of the anesthetic agents, especially opioids, the history of the recent respiratory infections or severe bronchopulmonary diseases, pregnancy, or breastfeeding.

The patients participated freely in the study and with a complete awareness about the study and also, the documented agreements were collected from the participants. This study was under the approval of the Iran University of Medical Sciences (IUMS) with the code of IR. IUMS.FMD.REC.1399.115 and was recorded in the clinical trial system with the ID of IRCT20200502047269N1. First, demographic data including age, gender, history of diabetes, hypertension, and addiction were recorded. Then, vital signs of the patients were evaluated. All of the patients were candidates for AVF formation and they were stable hemodynamically to minimize the effects of confounding factors on study results of the anesthesiological study. Furthermore, the monitoring of vital signs was continued during the anesthesiological procedures. Before starting the surgery, routine monitoring was done including pulse rate, electrocardiogram, noninvasive blood pressure monitoring, and SPO2. Then, the patients were divided into two groups and the blind sequencing of the patients was done using the website: https://www.sealedenvelope.com/simple-randomiser/v1/lists.

At the beginning of the procedure, 100 mg of subcutaneous lidocaine was injected for all of the patients. For the first group, DEX (intravenous bolus dose of 1 μg/kg in 10 min and the maintenance dose of 0.5 μg/kg/h) and for the second group REM (Intravenous bolus dose of 1 μg/kg in 10 min and the maintenance dose of 0.2 μg/kg/min) were injected. The SpO2 was measured when the initial incision was made and then after 10 min, 30, 60, 90, and 120 min after finishing the surgery in the recovery phase was also evaluated [Figure 1]. The data were analyzed using SPSS version 22, two-way repeated measures (ANOVA), and independent t-test.

Figure 1: The flow diagram of the study. ESRD: End stage renal disease, SpO2: Arterial hemoglobin saturation, PR: Pulse rate, NIBP: Noninvasive blood pressure monitoring, ECG: Electrocardiogram, DEX: Dexmedetomidine, REM: Remifentanil, AVF: Arteriovenous fistula

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  Results 

Demographic data

In this study, 40 patients were participated. The mean age in the DEX and the REM groups were 57.95 ± 10.86 and 59.5 ± 10.45 years old, respectively, and there was no any significant difference between these two groups (P = 0.648). In the DEX group, 70% of the patients were male and 30% were female. In addition, in the REM group, 55% of the patients were male and 45% were female and the difference between the two groups was not statistically significant (P = 0.327). The history of hypertension in the DEX and RME groups was 80% and 85%, respectively (P = 1.00). Furthermore, 60% of the patients in the DEX group were diabetic, and it was 45% in the REM group. Furthermore, the difference was not statistically significant (P = 0.342). In addition, the rate of addiction was close to each other in both groups and it was 10% and 15% in the DEX and REM groups, respectively (P = 0.633). Body mass index in the DEX and REM groups were 26.7 ± 3.42 kg/m2 and 25.15 ± 2.61 kg/m2, respectively, with no statistically significant difference (P = 0.115) [Table 1].

The comparison of SpO2 in the dexmedetomidine and remifentanil groups

For evaluation of SpO2, the measurement was done using pulse oximeter several times during and after the surgery. SpO2 on the beginning of the surgery and just after the surgical incision, was 97.95 ± 1.50 in the DEX and 98.10 ± 1.48 in the REM group (P = 0.589). SpO2 assessment was continued during the surgery in different times including 10 min after starting the surgery and 30, 60, 90, and 120 min after the surgery in the recovery phase. 10 min after the beginning of the surgery, SpO2 was 97.85 ± 1.23 in the DEX group and 97.85 ± 0.88 in the REM group (P = 0.884). Thirty minutes after the surgery in the recovery phase, SpO2 in the DEX and the REM groups were 97.95 ± 1.15 and 97.60 ± 1.14, respectively (P = 0.340). 60 min after the surgery SpO2 in the DEX and the REM groups were 98.15 ± 1.09 and 98.05 ± 0.89, respectively (P = 0.876). After 90 min, SpO2 in the DEX and the REM groups were 98.15 ± 1.14 and 98.05 ± 1.23, respectively (P = 0.693). Finally, 120 min after the surgery Spo2 was 98.10 ± 1.17 in the DEX and 98.25 ± 1.12 in the REM groups (P = 0.680). Overall, no statistically significant difference was found with regard to SpO2 while using DEX or REM in the different times of assessment [Table 2] and [Figure 2].

Figure 2: The diagram for comparing the mean and standard deviation of Spo2 on the beginning of the surgery, during and after the surgery in the frequent times of evaluation in the two groups

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Table 2: The variability of oxygen saturation in two groups of the study

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The result of the two-way repeated measure ANOVA showed that the difference in SpO2 in the two groups was not statistically significant (F = 0.032, df = 1, P = 0.859), and the effect of the group was not prominent. Furthermore, the effect of time was not statistically significant (F = 0.968, df = 5, P = 0.414) and SpO2 was not so different in the several times of evaluation. Finally, according to the results of the mentioned analysis, the difference in the group and time was not prominent and SpO2 changes during the study were approximately equal in the two groups.

The side effects of the anesthetic agents

Cochran's q-test analysis showed that the incidence of bradycardia and tachycardia on the beginning of the surgery after the incision, was 17.5% (7 cases), and 10 min after the beginning of the surgery was 30% (12 cases). In addition, they were seen in 7.5% (three patients), and 5% (two patients) after 30 and 60 min, respectively. The same results were repeated after 90 and 120 min, respectively.

  Discussion 

Preparing favorable ventilation and continues oximetry in any type of anesthetic procedure is essential and plays an important role not only for saving the safety of the patient but also for preventing the long-term complications of the anesthesia. In this study, the efficacy and the safety of two agents including DEX and REM were studied in the patients who underwent AVF formation. The result of our study showed that there is not any significant difference in using DEX or REM in the patients undergo AVF formation. Furthermore, other side effects of these two agents, for example, tachycardia and bradycardia were inappreciable.

Our study showed that there was not any significant difference in SpO2 between using REM or DEX. In the previous studies, the effect of these two agents on the oximetry parameters, side effects, and hemodynamic status of the patients was evaluated. The study of Xu T. was done among the patients who underwent awake intubation and compared two agents including DEX and REM. The results showed that the levels of SpO2 were not different by using any of these two agents.[31] However, the study of St-Pierre et al. showed different results. They concluded that the frequency of decreasing in SpO2 was significantly higher in the REM group.[32]

Most of the previous studies showed that DEX was superior to REM in stabilization of hemodynamic parameters. The study of Lee et al. was done among the elderlies with vertebroplasty and kyphoplasty for comparing DEX with REM. Their study revealed that the levels of SpO2 was higher in the patients of DEX group. Also, respiratory depression was lower in this group, but the analgesia was lower in comparison with REM group.[33] The study of Janatmakan et al. showed that using infusion of DEX could prepare favorable hemodynamical situation in the patients undergoing spinal surgery.[34] Furthermore, other studies showed that DEX is superior to REM in preventing respiratory depression.[32],[35],[36]

In the meta-analysis done by Tang et al., the efficacy and the safety of DEX and REM in the aware patients who underwent endoscopic fiberoptic intubation were compared to each other. Both agents were acceptable and tolerated very well by the patients, but DEX was more effective in decreasing the incidence of hypoxia and memory recall of endoscopy.[37] On the other hand, the study of Beloeil et al. in the noncardiac intermediate or major surgeries showed that DEX was not superior to REM. Furthermore, the serious side effects of DEX including hypoxemia and bradycardia were dominant.[38] In the study done by Gazi et al., the patients who underwent hysteroscopy were studied. Their study showed that the postsurgical pain was lower in the DEX group and the hemodynamic parameters were more stable, but 30 min after the surgery, the mentioned parameters were more favorable in the REM group.[39] Another study was done in the patients who underwent hysteroscopy by Park et al. and two combined agents were compared with each other including DEX-REM and propofol-REM. Their study revealed that in the first group with the combination of DEX, the prevalence of respiratory depression was lower and the hemodynamic complications were not higher.[40]

According to the mentioned previous studies DEX can be superior to REM for preventing respiratory depression. Our study showed that there was not any significant difference in using DEX or REM in the anesthesiological procedures. It seems that in the critically ill or complicated patients DEX is a better choice. The patients with ESRD are the critical patients and they may be complicated with other underlying diseases, so DEX is preferable in this group of patients.

  Conclusion 

The results of our study showed that in the patients who underwent AVF formation, there was not any significant difference in the SpO2 measurement in different times of evaluation. Furthermore, the side effects of these two drugs on the heart rate and the incidence of bradycardia and tachycardia were low. It seems that although there is not any superiority in using DEX over REM in patients who undergo AVF formation, DEX is preferable. More studies on the higher number of groups of patients undergoing different surgeries, especially in the patients with underlying diseases and also, evaluating the other side effects of these agents are recommended.

Ethical clearance

This study was under the approval of the Iran University of Medical Sciences (IUMS) with the code of IR. IUMS.FMD. REC.1399.115 and was recorded in the clinical trial system with the ID of IRCT20200502047269N1. Date: 2021.24.1.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 

  References 
1.Anupama B, Ravishankar K, Working mechanism and utility of pulse oximeter. Int J Sport, Exer Health Res 2018;2:111-3.  
    2.Chugh S, Kaur J. Low-cost calibration free Pulse oximeter. 2015 Annual IEEE India Conference (INDICON). 2015, p. 1-5.  
    3.Tusman G, Bohm SH, Suarez-Sipmann F. Advanced uses of pulse oximetry for monitoring mechanically ventilated patients. Anesth Analg 2017;124:62-71.  
    4.Kyriacou PA. Pulse oximetry in the oesophagus. Physiol Meas 2006;27:R1-35.  
    5.Schnapp LM, Cohen NH. Pulse oximetry. Uses and abuses. Chest 1990;98:1244-50.  
    6.Mendelson Y. Pulse oximetry: Theory and applications for noninvasive monitoring. Clin Chem 1992;38:1601-7.  
    7.Alexander CM, Teller LE, Gross JB. Principles of pulse oximetry: Theoretical and practical considerations. Anesth Analg 1989;68:368-76.  
    8.Eichhorn JH, Cooper JB, Cullen DJ, Maier WR, Philip JH, Seeman RG. Standards for patient monitoring during anesthesia at Harvard medical school. JAMA 1986;256:1017-20.  
    9.Tremper KK, Barker SJ. Pulse oximetry. Anesthesiology 1989;70:98-108.  
    10.Wood EH, Geraci JE. Photoelectric determination of arterial oxygen saturation in man. J Lab Clin Med 1949;34:387-401.  
    11.Severinghaus JW, Astrup PB. History of blood gas analysis. Int Anesthesiol Clin 1987;25:1-224.  
    12.Comroe JH Jr., Botelho S. The unreliability of cyanosis in the recognition of arterial anoxemia. Am J Med Sci 1947;124:1-6.  
    13.Lundsgaard C, Van Slyke DD. Cyanosis. Med 1921;2:1-76.  
    14.Stephen CR, Slater HM, Johnson AL, Sekelj P. The oximeter – A technical aid for the anesthesiologist. Anesthesiology 1951;12:541-55.  
    15.Aoyagi T, Kishi M, Yamaguchi K, Watanabe S. Improvement of the earpiece oximeter. Japanese Journal of Medical Electronics and Biomedical Engineering. In: Abstracts of the 13th annual meeting of the Japanese Society of Medical Electronics and Biological Engineering. Oosaka: 1974. p. 90-1.  
    16.Whitcher C, New W, Bacon BE. Perianesthetic oxygen saturation versus skill of the anesthetist. Anesthesiology 1982;57:A172.  
    17.American Society of Anesthesiologists. Standards for basic intra-operative monitoring. Am Soc Anesthesiol Newsl 1986;50:12-13.  
    18.Stevenson RA, Schlesinger JJ, Wallace MT. Effects of divided attention and operating room noise on perception of pulse oximeter pitch changes: A laboratory study. Anesthesiology 2013;118:376-81.  
    19.List WF. The importance of pulse oximetry for anesthesia. Anaesthesiol Reanim 1991;16:5-10.  
    20.Kennedy BK, Berger SL, Brunet A, Campisi J, Cuervo AM, Epel ES, et al. Geroscience: Linking aging to chronic disease Cell 2014;159:709-13.  
    21.Kazancioğlu R. Risk factors for chronic kidney disease: An update. Kidney Int Suppl (2011) 2013;3:368-71.  
    22.McClellan WM, Flanders WD. Risk factors for progressive chronic kidney disease. J Am Soc Nephrol 2003;14:S65-70.  
    23.Stevens LA, Viswanathan G, Weiner DE. Chronic kidney disease and end-stage renal disease in the elderly population: Current prevalence, future projections, and clinical significance. Adv Chronic Kidney Dis 2010;17:293-301.  
    24.Shaheen FA, Al-Attar B, Ahmad MK, Follero PM. Burden of disease: Prevalence and incidence of endstage renal disease in Middle Eastern countries. Clin Nephrol 2020;93:120-3.  
    25.Cimen SG, Oğuz E, Gundogmus AG, Cimen S, Sandikci F, Ayli MD. Listening to music during arteriovenous fistula surgery alleviates anxiety: A randomized single-blind clinical trial. World J Transplant 2020;10:79-89.  
    26.Gutman RA, Amara AH. Outcome of therapy for end-stage uremia: An informed prediction of survival rate and degree of rehabilitation. Postgrad Med 1978;64:183-94.  
    27.Levy NB, Wynbrandt GD. The quality of life on maintenance haemodialysis. Lancet 1975;1:1328.  
    28.Gutman RA, Stead WW, Robinson RR. Physical activity and employment status of patients on maintenance dialysis. N Engl J Med 1981;304:309-13.  
    29.Huncke TK, Adelman M, Jacobowitz G, Maldonado T, Bekker A. A prospective, randomized, placebo-controlled study evaluating the efficacy of dexmedetomidine for sedation during vascular procedures. Vasc Endovascular Surg 2010;44:257-61.  
    30.Cortinez LI, Hsu YW, Sum-Ping ST, Young C, Keifer JC, Macleod D, et al. Dexmedetomidine pharmacodynamics: Part II: Crossover comparison of the analgesic effect of dexmedetomidine and remifentanil in healthy volunteers. Anesthesiology 2004;101:1077-83.  
    31.Xu T, Li M, Ni C, Guo XY. Dexmedetomidine versus remifentanil for sedation during awake intubation using a Shikani optical stylet: A randomized, double-blinded, controlled trial. BMC Anesthesiol 2016;16:52.  
    32.St-Pierre P, Tanoubi I, Verdonck O, Fortier LP, Richebé P, Côté I, et al. Dexmedetomidine versus remifentanil for monitored anesthesia care during endobronchial ultrasound-guided transbronchial needle aspiration: A randomized controlled trial. Anesth Analg 2019;128:98-106.  
    33.Lee JM, Lee SK, Lee SJ, Hwang WS, Jang SW, Park EY. Comparison of remifentanil with dexmedetomidine for monitored anaesthesia care in elderly patients during vertebroplasty and kyphoplasty. J Int Med Res 2016;44:307-16.  
    34.Janatmakan F, Nassajian N, Jarirahmadi S, Tabatabaee K, Zafari M. Comparison of the effect of dexmedetomidine and remifentanil on pain control after spinal surgery: A double-blind, randomized clinical trial. Anesth Pain Med 2021;11:e111533.  
    35.Hoy SM, Keating GM. Dexmedetomidine: A review of its use for sedation in mechanically ventilated patients in an intensive care setting and for procedural sedation. Drugs 2011;71:1481-501.  
    36.Goettel N, Bharadwaj S, Venkatraghavan L, Mehta J, Bernstein M, Manninen PH. Dexmedetomidine versus propofol-remifentanil conscious sedation for awake craniotomy: A prospective randomized controlled trial. Br J Anaesth 2016;116:811-21.  
    37.Tang ZH, Chen Q, Wang X, Su N, Xia Z, Wang Y, et al. A systematic review and meta-analysis of the safety and efficacy of remifentanil and dexmedetomidine for awake fiberoptic endoscope intubation. Medicine (Baltimore) 2021;100:e25324.  
    38.Beloeil H, Garot M, Lebuffe G, Gerbaud A, Bila J, Cuvillon P, et al. Balanced opioid-free anesthesia with dexmedetomidine versus balanced anesthesia with remifentanil for major or intermediate noncardiac surgery. Anesthesiology 2021;134:541-51.  
    39.Gazi M, Abitağaoğlu S, Turan G, Köksal C, Akgün FN, Ari DE. Evaluation of the effects of dexmedetomidine and remifentanil on pain with the analgesia nociception index in the perioperative period in hysteroscopies under general anesthesia. A randomized prospective study. Saudi Med J 2018;39:1017-22.  
    40.Park S, Choi SL, Nahm FS, Ryu JH, Do SH. Dexmedetomidine-remifentanil versus propofol-remifentanil for monitored anesthesia care during hysteroscopy: Randomized, single-blind, controlled trial. Medicine (Baltimore) 2020;99:e22712.  
    
  [Figure 1], [Figure 2]
 
 
  [Table 1], [Table 2]