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

Phase 4

Not yet recruiting

• Conditions: Laparoscopic Abdominal Surgery; Anesthesia, General; Emergence Agitation; Remimazolam Besylate; Perioperative Sedation
• Interventions: Drug: Rematazolam Besylate; Drug: Propofol; Drug: Sevoflurane; Drug: Sufentanil; Drug: Cisatracurium Besylate; Drug: Remifentanil

• Registration Number: NCT05624424
• Lead Sponsor: Second Affiliated Hospital of Nanchang University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-07
• Study Start: 2022-11-15
• Study First Submitted QC: 2022-11-19
• Last Update Submitted: 2022-11-19
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1317

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;

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Sufentanil	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.
Sevoflurane	Cisatracurium Besylate	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.
Remimazolam Besylate	Rematazolam Besylate	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.
Propofol	Cisatracurium Besylate	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.
Remimazolam Besylate	Cisatracurium Besylate	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.
Remimazolam Besylate	Sufentanil	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.
Remimazolam Besylate	Remifentanil	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.
Propofol	Propofol	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.
Propofol	Remifentanil	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.
Sevoflurane	Sevoflurane	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.
Sevoflurane	Sufentanil	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.
Sevoflurane	Remifentanil	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.

Primary Outcome Measures

Name	Time	Method
The incidence of emergence agitation	Duration from the time patients awakening to the time of departure from PACU, average 1 hour.	The Richmond Agitation-Sedation Scale (RASS) ≥ +1 points indicates the presence of emergence agitation.

Secondary Outcome Measures

Name	Time	Method
The incidence of postoperative delirium	Record in the mornings on the 1st, 3rd and 7th day after operation.	The incidence of postoperative delirium was assessed using CAM Scale.
Diastolic pressure	"30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Heart rate	"30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Delayed emergence	Duration from the time patients awakening to the time of departure from PACU, average 1 hour.	Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Complication	During the perioperative period, up to 1 week.	All the perioperative complications are recorded.
Hospital expenses	After the patient is discharged from the hospital, average 1 week.	Hospitalization costs include total hospitalization costs and anesthesia costs.
Postoperative Pain	Record in the mornings on the 1st, 3rd and 7th day after operation.	The Numericrating scale (NRS) is grouped from 0 to 10. The degree of pain increased directly with the score.
Hospitalization time	After the patient is discharged from the hospital, average 1 week.	The length of hospital stay is recorded.
Systolic pressure	"30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Mean pressure	"30 minutes before intubation", "immediately after intubation", "every 5 minutes after intubation until the patient leaves the post-anesthesia care unit, in about six hours", " mornings and afternoons on the 1st, 3rd and 7th day after operation".
Recovery times	Duration from the time patients awakening to the time of departure from PACU, average 1 hour.	Recovery times is defined as the period from discontinuation of anesthetic drugs to the recovery of the patient's self-consciousness and can respond correctly to external stimuli.
30-day all-cause mortality	30 days after surgery	30-day all-cause mortality is recorded.

Trial Locations

Locations (6)

Tumor Hospital of Jiangxi Province; 🇨🇳 Nanchang, Jiangxi, China

People's Hospital of Ganzhou; 🇨🇳 Ganzhou, Jiangxi, China

the First Affiliated Hospital of Gannan Medical College, Gannan Medical College; 🇨🇳 Ganzhou, Jiangxi, China

The First People's Hospital of JiuJiang; 🇨🇳 Jiujiang, Jiangxi, China

the Second Affiliated Hospital of Nanchang University, Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Shangrao People's Hospital; 🇨🇳 Shangrao, Jiangxi, China