Clinical trial NCT05624424: Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery
Official title: Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Emergence Agitation
Remimazolam Besylate
Perioperative Sedation
Laparoscopic Abdominal Surgery
Anesthesia, General
Keywords: Emergence Agitation
Remimazolam Besylate
Propofol
Sevoflurane
Laparoscopic Abdominal Surgery
Perioperative Sedation
Anesthesia, General
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
Collaborators: name: Yichang Humanwell Pharmaceutical Co., Ltd., China
First posted: 2022-11-22
Enrollment: 1317
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a RCTs.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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;

Primary outcomes:
measure: The incidence of emergence agitation
timeFrame: Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.
measure: The incidence of emergence agitation
timeFrame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Secondary outcomes:
measure: Systolic pressure
timeFrame: "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".
measure: Diastolic pressure
timeFrame: "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".
measure: Mean pressure
timeFrame: "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".
measure: Heart rate
timeFrame: "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".
measure: Recovery times
timeFrame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
measure: Delayed emergence
timeFrame: Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
measure: The incidence of postoperative delirium
timeFrame: Record in the mornings on the 1st, 3rd and 7th day after operation.
measure: Postoperative Pain
timeFrame: Record in the mornings on the 1st, 3rd and 7th day after operation.
measure: Complication
timeFrame: During the perioperative period, up to 1 week.
measure: Hospitalization time
timeFrame: After the patient is discharged from the hospital, average 1 week.
measure: Hospital expenses
timeFrame: After the patient is discharged from the hospital, average 1 week.
measure: 30-day all-cause mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Ganzhou
country: China
facility: People's Hospital of Ganzhou
state: Jiangxi
city: Ganzhou
country: China
facility: the First Affiliated Hospital of Gannan Medical College, Gannan Medical College
state: Jiangxi
city: Jiujiang
country: China
facility: The First People's Hospital of JiuJiang
state: Jiangxi
city: Nanchang
country: China
facility: the Second Affiliated Hospital of Nanchang University, Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: Tumor Hospital of Jiangxi Province
state: Jiangxi
city: Shangrao
country: China
facility: Shangrao People's Hospital
state: Jiangxi
Study officials:
References: