Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery

Nanchang University

Status and phase: Not yet enrolling; Phase 4

Conditions: Remimazolam Besylate; Emergence Agitation; Anesthesia, General; Laparoscopic Abdominal Surgery; Perioperative Sedation

Treatments: Drug: Cisatracurium Besylate; Drug: Sevoflurane; Drug: Propofol; Drug: Remifentanil; Drug: Sufentanil; Drug: Rematazolam Besylate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05624424

2022-EA-2

Details and patient eligibility

About

Emergence agitation (EA) is a transient, self-limited, non-fluctuating state of psychomotor excitement, which closely revolves around the emergence of general anesthesia. Uncontrolled EA during the recovery period increases the potential risk of injury to patients and medical staff, resulting in varying degrees of adverse consequences, such as elevated blood pressure, incision rupture, bleeding, cardio-cerebrovascular accidents and so on, leading to a great waste of resources.

Accumulating scientific evidence indicates that the incidence of EA is related to the use of perioperative sedative drugs. As a novel ultra-short-acting benzodiazepines drugs, Remimazolam has been accepted for induction and maintenance of clinical anesthesia. Compared to traditional benzodiazepines drugs, Remimazolam combines the safety of midazolam with the effectiveness of propofol, and also has the advantages of acting quickly, short half-life, no injection pain, slight respiratory depression, independent of liver and kidney metabolism, long-term infusion without accumulation, and has a specific antagonist: flumazenil. This study aims to investigate whether perioperative sedation of Remimazolam besylate, propofol, and sevoflurane have different effects on the incidence of emergence agitation and hemodynamics in patients undergoing laparoscopic abdominal surgery.

Enrollment: 1,317 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1 Aged 18-65 years, sex was not limited;
• 2 BMI 18-30kg/m2;
• 3 Patients were scheduled for elective laparoscopic abdominal surgery under general anesthesia, the operation time 2h~4h;
• 4 ASA Ⅰ-III;

Exclusion criteria

• 1 Relative contraindications to general anesthesia: Patients with severe heart and lung disease, severe infection, uncontrolled hypertension, diabetes, and severe diabetic complications;
• 2 Abnormal renal and liver function: AST or ALT≥2.5×ULN, TBIL≥1.5×ULN, Serum creatinine concentration (SCC)≥1.5×ULN;
• 3 People with a history of mental illness or long-term use of psychotropic drugs (dementia, schizophrenia), chronic analgesic drug use, alcoholism, and cognitive impairment;
• 4 Any cardiovascular or cerebrovascular accidents occurred within 3 months, such as myocardial infarction, stroke, transient ischemic attack;
• 5 Female pregnant patients;
• 6 Patients undergoing hepatobiliary surgery;
• 7 Allergy to the experimental drug;
• 8 Unable to cooperate to complete the test, the patient or family member rejected the participant;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,317 participants in 3 patient groups

Remimazolam Besylate

Experimental group

Description:

Induction of anesthesia Slowly inject Remimazolam Besylate 0.3\~0.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS\<60, if the degree of sedation is insufficient, additional Remimazolam Besylate (0.05 mg/kg each time) is allowed. After the LoC, sufentanil 0.3\~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.

Treatment:

Drug: Sufentanil

Drug: Rematazolam Besylate

Drug: Remifentanil

Drug: Cisatracurium Besylate

Propofol

Active Comparator group

Description:

Induction of anesthesia Slowly inject Propofol 2\~2.5 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS\<60, if the degree of sedation is insufficient, additional Propofol (0.5 mg/kg each time) is allowed. After the LoC, sufentanil 0.3\~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.

Treatment:

Drug: Sufentanil

Drug: Remifentanil

Drug: Propofol

Drug: Cisatracurium Besylate

Sevoflurane

Active Comparator group

Description:

Induction of anesthesia Slowly inject Etomidate 0.03 mg/kg (about 1 minute) until loss of consciousness (LoC) and BIS\<60, if the degree of sedation is insufficient, additional etomidate (0.03 mg/kg each time) is allowed. After the LoC, sufentanil 0.3\~0.5 ug/kg and cisatracurium besilate 0.2-0.3 mg/kg are injected intravenously. After the muscles are sufficiently relaxed and blood circulation is stable, the tracheal tube is inserted under a glide scope.

Treatment:

Drug: Sufentanil

Drug: Remifentanil

Drug: Cisatracurium Besylate

Drug: Sevoflurane