Efficacy of Pretreatment with Remimazolam on Prevention of Propofol-Induced Injection Pain in Patients Undergoing Gastroscopy: A Prospective, Sing-Center, Randomized, Double-Blinded and Placebo-Controlled Clinical Trial

Abstract

Abstract Objective To evaluate the efficacy of remimazolam pretreatment in preventing propofol-induced injection pain (PIP) in patients undergoing gastroscopy. Methods One hundred and forty patients( ASA Ⅰ -Ⅱ, aged 18–65 years, BMI 18–28 kg/m2) who had undergone selective gastroscopy were randomized into either a saline group ( group S) or a remimazolam group ( group R) ( n = 70 for each) on a computer-generated random number basis. The patients in group S received normal saline (0.1 mL/kg) and those in group R were administered remimazolam (0.1 mg/kg) via intravenous infusion for 60 seconds. Group S and R patients were intravenously received propofol (0.5 mL/s) until loss of consciousness. A different anesthesiologist who was unaware of the pretreatment was responsible for maintaining the outcome. The primary endpoint of our study was the incidence of PIP, which was measured using a 4-point scale. Secondary endpoints include the intensity of PIP, vital signs, characteristics of surgery and recovery, and adverse events. Results The incidence of PIP was significantly lower in group R than in group S (12.86 vs 51.43%, p < 0.001), and a lower percentage of patients presented with moderate PIP (2.86 vs 20.0%, p < 0.001). Moreover, lower consumption of propofol, shorter recovery time, and greater patient satisfaction were observed in group R than in group S. Conclusion Pretreatment with remimazolam can effectively reduce the incidence and intensity of PIP in gastroscopy and shorten the recovery time without severe adverse effects. Trial Registration Chinese Clinical Trial Registry (identifier: ChiCTR2200063793).