The impact of remimazolam besylate on maintaining anesthesia during general anesthesia for patients requiring laparoscopic surgery on their vital signs and liver and kidney functions.
Conditions
Interventions
Propofol group:Conventional induction, combined intravenous-inhalation with propofol and sevoflurane to maintain anesthesia
Remimazolam group:Conventional induction, combined intravenous-inhalation of remimazolam and sevoflurane for maintenance anesthesia
Sponsors
Kaifeng 155 Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age: 18 to 65 years old, gender not limited, weight: kg=(height -100)±15%; 2.Subjects undergoing elective laparoscopic surgery under general anesthesia who require endotracheal intubation; 3.American Society of Anesthesiologists ASA Class I - III; 4.Informed consent, voluntary participation in this trial, and signing of the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Those with chronic pain who have been using painkillers for a long time, psychotropic drugs (including opioids, NSAIDs, sedatives, and antidepressants), and alcohol abusers; 2.Weight is 15% lower or higher than the standard weight; 3.The liver and kidney functions (ALT, AST, BUN, Cr) were abnormally elevated before the operation; 4.There is a history of abnormal surgical anesthesia recovery in the past; 5.Sedatives, analgesics and anti-pruritus drugs were used 24 hours before the operation; 6.It is expected to be difficult intubation; 7.Perform liver surgery; 8.Has a history of opioid allergy; 9.Have taken monoamine oxidase inhibitor drugs or antidepressants within fifteen days; 10.Shock subjects; 11.COPD subjects; 12.Pregnant women or new mothers; 13.Have participated in other drug trials within three months; 14.Subjects who the researchers considered unsuitable to participate in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The maximum change rate of systolic blood pressure (SBP) and heart rate (HR) during the induction intubation period and the maintenance period of anesthesia; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative safety: low oxygen saturation (SpO?30 seconds), bradycardia (HR100bpm), tota;Organ function: Comparison of liver (ALT, AST) and kidney (Cr, BUN) function indicators within 24 hours before surgery and within 24-48 hours after surgery.;Postoperative recovery: The time from the cessation of the study drug to extubation (recovery time), the time of the first oral water intake after the operation, the time of the first ambulation after; | — |
Countries
China
Contacts
Public ContactZhang Leiguang
Kaifeng 155 Hospital
Outcome results
None listed