Effect of intermittent pringle manipulation on serum potassium concentration during laparoscopic hepatectomy: a self-controlled study protocol

Abstract

Background Intermittent Pringle Manipulation (IPM) is among the most common methods used for controlling blood loss during hepatectomy. Ischaemia–reperfusion injury has also been associated with IPM. Ischaemic injury exposes the liver cells to hypoxia, adenosine triphosphate depletion, pH changes, and cellular metabolic stress, all of which can lead to cell damage and death. Reperfusion injury is caused by microcirculatory dysfunction, hypoxia, oxidative stress, and apoptosis. The pathophysiological mechanism of ischaemia-reperfusion injury is hyperkalaemia. Hyperkalaemia is closely related to the electrophysiological activity of the myocardium. Acute hyperkalaemia is associated with life-threatening ventricular arrhythmia and sudden cardiac arrest. Therefore, it is necessary to observe changes in patient serum potassium concentrations during IPM to provide a reference for developing a secure anaesthesia management approach. Methods and analysis This was a single-centre, open, non-interventional, self-controlled study. All eligible consecutive patients were recruited from a regional medical centre and scheduled for elective hepatectomy. There was no control group; all participants were continuously enrolled from 1 September 2023 to 31 August 2024. The primary outcome was the perioperative serum potassium concentration during IPM. Secondary outcomes included perioperative electrocardiogram changes, lactic acid status, postoperative serum potassium concentration, alanine amine transferase, and aspartate amine transferase peaks, adverse events, serious adverse events, and postoperative hospital stay. These parameters were statistically compared. Subgroup analysis will be performed according to liver disease type and duration of IPM. Discussion Our finding will provide a reference for developing a secure anaesthesia management approach for anesthesiologists. Ethics and dissemination The Biomedical Ethics Review Committee of the People’s Hospital of Jianyang City approved the study protocol (ethics reference: JY202383). All relevant ethical guidelines were followed in this study. The findings will be disseminated in peer-reviewed journals, publicly available reports to be published online, and academic conferences.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ChiCTR2300074753

Funding Statement

the Chengdu Medical Research Project No 2023462 and research project of the Peoples Hospital of Jianyang city JYk202403

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The Biomedical Ethics Review Committee of the Peoples Hospital of Jianyang City approved the study protocol (ethics reference JY202383)

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

No datasets were generated or analysed during the current study. All relevant data from this study will be made available upon study completion.

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