Safety and efficacy of ketamine-dexmedetomidine combination versus dexmedetomidine alone in cirrhotic patients undergoing upper gastrointestinal endoscopy: a prospective controlled clinical trial

Abstract

BackgroundPatients with liver cirrhosis commonly undergo diagnostic and/or therapeutic upper gastrointestinal endoscopy (UGIE). These fragile patients are at increased risk to develop complications as most sedative drugs are metabolized by the liver.This prospective, randomized controlled trial was performed to compare sedo-analgesia with ketamine-dexmedetomidine combination (KD1) (n = 35) versus dexmedetomidine alone (D2) (n = 35) in cirrhotic patients undergoing UGIE.ResultsUGIE could be performed effectively and safely with the KD1 (n = 35) group compared with the D2 group as no significant change in hemodynamics (HR and MBP) and O2 saturation (SPO2) from baseline values (P value > 0.05) while the D2 group revealed a statistically significant drop in hemodynamic parameters when compared with the KD1 group (P value < 0.001).Also, the induction time was statistically significantly lower in the KD1 group (3.9 ± 0.9 min) compared to the D2 group (5.2 ± 1.1min) (P value < 0.05).Recovery time was statistically significant faster in the KD1 group (4.5 ± 1 min) versus the D2 group (6.1 ± 1.6 min) with P value < 0.05.Endoscopic procedure was highly effective in KD1 (100%) compared with D2 (71.4%) with P value < 0.001.Supplementary fentanyl was given to 10 patients (28.6%) in the D2 group versus 0% in the KD1 group (P value < 0.001).Regarding post-operative adverse effects, there was statistically significant discomfort in D2 (28.6%) compared with KD1 (5.7%) with P value = 0.02. Also, gagging was statistically significant in D2 (22.9%) compared with KD1 (2.9%) with P value = 0.03.ConclusionsThe ketamine-dexmedetomidine sedo-analgesia group is highly effective than the dexmedetomidine-alone group in UGIE procedures with rapid induction time, good hemodynamic stability good recovery profile with less post-operative adverse effects.Trial registeration1. IRB approval: 5 December 2016(Chairperson of Institutional Review Board of Ethics committee of Qena University Hospitals Prof. Ahmed Abuelyosr). The committee reference number is not applicable. 2. This study is registered in the Australian Newzeland Clinical Trial Registry (ANZCTR) at the number 12615000367549. Trial Id: ACTRN12615000367549, universal trial number(UTN): U1111-1165-6212.