Abstract

To evaluate the efficacy of remimazolam pretreatment in preventing propofol-induced injection pain (PIP) in patients undergoing gastroscopy. One hundred and forty patients (ASA I–II, aged 18–65 years, BMI 18–28 kg/m2) who were to undergo 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 s. 30 s after the injection of normal saline or remimazolam, patients received intravenously 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. The incidence of PIP was significantly lower in group R than in group S (13 vs 51%, p < 0.001), and a lower percentage of patients presented with moderate PIP (3 vs 20%, p < 0.001). Moreover, lower consumption of propofol, shorter recovery time, and greater patient satisfaction were observed in group R than in group S. Pretreatment with remimazolam can effectively reduce the incidence and intensity of PIP in gastroscopy and shorten the recovery time without severe adverse effects.Clinical Trials Registration: Trial Registration: Chinese Clinical Trial Registry (identifier: ChiCTR2200063793). Registry time: 16/09/2022. Registry name: Efficacy of Pre-Treatment with Remimazolam on Prevention of Propofol-Induced Injection Pain in Patients Undergoing Gastroscopy. The date of patient enrollment began from 2022-9-17 to 2022-10-10. The link to the registration: https://www.chictr.org.cn/showproj.html?proj=176004.

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