Abstract
Background: This study was devised to assess the efficacy and utility of bispectral index (BIS) monitoring as an adjunct to ciprofol-based sedation in patients undergoing gastrointestinal endoscopy, based on the hypothesis that BIS monitoring would reduce ciprofol consumption and shorten the time required for recovery.
Methods: A total of 140 patients scheduled to undergo painless gastrointestinal endoscopy procedures were enrolled in this study. Patients were intraoperatively randomized into BIS or control groups. The dose of ciprofol required was the primary study endpoint, while secondary endpoints included intraoperative SpO2 changes, induction time, the duration of endoscopic examination, time to awakening, time to post-anesthesia care unit (PACU) discharge, adverse event incidence, and satisfaction levels for both patients and endoscopists.
Results: The demographic characteristics of both enrolled cohorts were comparable. A significantly lower level of ciprofol consumption was observed for the BIS group relative to the control group (62.27±14.38 mg vs. 66.92±11.66 mg, respectively, P=0.037). The BIS group also presented with a shorter time to awakening (P<0.001) and PACU discharge (P<0.001), together with greater endoscopist satisfaction relative to the control group (P=0.029). The incidence of unfavorable outcomes was similar in both groups (P >0.05 for all).
Conclusions: These results show that BIS monitoring, when employed as an adjunct to outpatient ciprofol sedation, was associated with a significantly lower level of ciprofol consumption during gastrointestinal endoscopy procedures, together with reductions in the time to patient awakening and PACU discharge. This monitoring strategy may also lead to greater satisfaction among endoscopists.
Trial registration: This trial has been submitted to the Chinese Clinical Trial Registry (registration number: ChiCTR2300069868, registration date: 28/03/2023).