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

Background Patients 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 (KD 1 ) ( n = 35) versus dexmedetomidine alone (D 2 ) ( n = 35) in cirrhotic patients undergoing UGIE. Results UGIE could be performed effectively and safely with the KD 1 ( n = 35) group compared with the D 2 group as no significant change in hemodynamics (HR and MBP) and O 2 saturation (SPO 2 ) from baseline values ( P value > 0.05) while the D 2 group revealed a statistically significant drop in hemodynamic parameters when compared with the KD 1 group ( P value < 0.001). Also, the induction time was statistically significantly lower in the KD 1 group (3.9 ± 0.9 min) compared to the D 2 group (5.2 ± 1.1min) ( P value < 0.05). Recovery time was statistically significant faster in the KD 1 group (4.5 ± 1 min) versus the D 2 group (6.1 ± 1.6 min) with P value < 0.05. Endoscopic procedure was highly effective in KD 1 (100%) compared with D 2 (71.4%) with P value < 0.001. Supplementary fentanyl was given to 10 patients (28.6%) in the D 2 group versus 0% in the KD 1 group ( P value < 0.001). Regarding post-operative adverse effects, there was statistically significant discomfort in D 2 (28.6%) compared with KD 1 (5.7%) with P value = 0.02. Also, gagging was statistically significant in D 2 (22.9%) compared with KD 1 (2.9%) with P value = 0.03. Conclusions The 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 registeration 1. 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.