Clinical observation on the efficacy and safety of remimazolam tosilate in patients undergoing intestinal endoscopic submucosal dissection
Objective:To evaluate the efficacy and safety of remimazolam tosilate in patients undergoing intestinal endoscopic submucosal dissection(ESD).Methods:Eighty patients scheduled to undergo intestinal ESD were included and randomized to observational group(Group R)and control group(Group P).Patients in Group R were intravenously injected with remimazolam tosilate in dose of 0.2-0.3 mg/kg.By the scoring on modified Observer's Assessment of Alertness/Sedation(MOAA/S)scale arrived at ≤2,a gastroenterologist inserted a colonoscopy and the anesthesia was maintained in dosage of 1.0-2.0 mg/kg/h.An additional 3 mg remimazolam tosilate or 5 μg sufentanil was given,if the patient had any body movement or the MOAA/S score was ≥3.Patients in Group P were intravenously given propofol in dose of 1-2 mg/kg.When the MOAA/S score was ≤2,a gastroenterologist inserted a colonoscopy and the anesthesia was maintained in dosage of4-5 mg/kg/h.An additional 30 mg propofol or 5 μg sufentanil was given,if the patient had any body movement or the MOAA/S score was ≥3.The total dose of sufentanil used for each patient did not exceed 15 μg.The following information was recorded,including patient's heart rate(HR),blood pressure,respiratory rate(RR),SpO2 and bispectral index(BIS)in supine position(T1),on turning to lateral position(T2),at endoscope insertion(T3),and 30 minutes after surgery(T4);MOAA/S score 30 minutes after surgery;recovery time,number of body movement and number of additional medication;respiratory depression,injection pain,allergic reaction and other adverse events.Results:The HRs of patients in Group P at T3 and T4 were lower than those at T1 and T2(P＜0.05),and the HR at T4 was lower than that at T3(P＜0.05).The HR of patients in Group R at T4 was lower than that at T,(P＜0.05),and the HRs at T3 and T4 were lower than that at T2(P＜0.05).The systolic blood pressure(SBP),diastolic blood pressure(DBP)and RR of patients in both groups at T3 and T4 were lower than those at T1 and T2(P＜0.05).The Sp02 of patients in Group P at T2 and T3 were higher than that at T1(P＜0.05),and those of patients in Group R at T2,T3 and T4were higher than that at T1(P＜0.05).The BIS of patients in both groups were lower at T3 and T4 than at T1 and T2(P＜0.05),and the BIS at T4 was lower than that at T3(P＜0.05).The SBP and DBP of patients in Group P at T3 and T4 were lower than those of Group R(P＜0.05),and the BIS at T4 was lower than that of Group R(P＜0.05).The recovery time of patients in Group R was longer than that in Group P group(P＜0.05).There was no significant difference in the number of body movement and additional medication,injection pain,allergic reaction and other adverse events between two groups(P＞0.05).Conclusion:Remimazolam tosilate can be used for intestinal ESD with more stable circulation and a longer time to restore senses.
万方数据
维普
