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

Anesthesia, General Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05624424
• Other study ID #: 2022-EA-2
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 15, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital of Nanchang University
• Contact: Fuzhou Hua, professor
• Phone: +8615170238929
• Email: huafuzhou[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1317
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?-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;

Related Conditions & MeSH terms

• Anesthesia, General
• Emergence Agitation
• Emergence Delirium
• Laparoscopic Abdominal Surgery
• Psychomotor Agitation

Intervention

Drug:
• Rematazolam Besylate
Anesthesia was induced with Rematazolam Besylate 0.3~0.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by remimazolam 1-3 mg/kg/h until the end of surgery.
• Propofol
Anesthesia was induced with Propofol 2~2.5 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by remimazolam 5~12 mg/kg/h until the end of surgery.
• Sevoflurane
Anesthesia was induced with etomidate 0.03 mg/kg (about 1 minute) by intravenous injection until the loss of consciousness (LoC) and BIS<60, followed by 2 %-3 % Sevoflorane until the end of surgery.
• Sufentanil
Anesthesia was induced with Sufentanil 0.3~0.5 ug/kg by intravenous injection after the LoC and BIS<60.
• Cisatracurium Besylate
Anesthesia was induced with cisatracurium besilate 0.2-0.3 mg/kg by intravenous injection after the LoC and BIS<60, followed by 0.1 mg/kg/h Cisatracurium Besylate during the operation.
• Remifentanil
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.

Locations

Country	Name	City	State
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	Tumor Hospital of Jiangxi Province	Nanchang	Jiangxi
China	Shangrao People's Hospital	Shangrao	Jiangxi

Sponsors (2)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Nanchang University	Yichang Humanwell Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of emergence agitation	The Riker Sedation-Agitation Scale (RSAS) score = 5 points indicates the presence of emergence agitation.	Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.
Primary	The incidence of emergence agitation	The Richmond Agitation-Sedation Scale (RASS) = +1 points indicates the presence of emergence agitation.	Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Secondary	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".
Secondary	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".
Secondary	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".
Secondary	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".
Secondary	Recovery times	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.	Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Secondary	Delayed emergence	Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.	Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Secondary	The incidence of postoperative delirium	The incidence of postoperative delirium was assessed using CAM Scale.	Record in the mornings on the 1st, 3rd and 7th day after operation.
Secondary	Postoperative Pain	The Numericrating scale (NRS) is grouped from 0 to 10. The degree of pain increased directly with the score.	Record in the mornings on the 1st, 3rd and 7th day after operation.
Secondary	Complication	All the perioperative complications are recorded.	During the perioperative period, up to 1 week.
Secondary	Hospitalization time	The length of hospital stay is recorded.	After the patient is discharged from the hospital, average 1 week.
Secondary	Hospital expenses	Hospitalization costs include total hospitalization costs and anesthesia costs.	After the patient is discharged from the hospital, average 1 week.
Secondary	30-day all-cause mortality	30-day all-cause mortality is recorded.	30 days after surgery