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

Primary Purpose

Emergence Agitation, Remimazolam Besylate, Perioperative Sedation

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Rematazolam Besylate
Propofol
Sevoflurane
Sufentanil
Cisatracurium Besylate
Remifentanil
Sponsored by
Second Affiliated Hospital of Nanchang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Agitation focused on measuring Emergence Agitation, Remimazolam Besylate, Propofol, Sevoflurane, Laparoscopic Abdominal Surgery, Perioperative Sedation, Anesthesia, General

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

  • People's Hospital of Ganzhou
  • the First Affiliated Hospital of Gannan Medical College, Gannan Medical College
  • The First People's Hospital of JiuJiang
  • the Second Affiliated Hospital of Nanchang University, Nanchang University
  • Tumor Hospital of Jiangxi Province
  • Shangrao People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Remimazolam Besylate

Propofol

Sevoflurane

Arm 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.

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.

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.

Outcomes

Primary Outcome Measures

The incidence of emergence agitation
The Riker Sedation-Agitation Scale (RSAS) score ≥ 5 points indicates the presence of emergence agitation.
The incidence of emergence agitation
The Richmond Agitation-Sedation Scale (RASS) ≥ +1 points indicates the presence of emergence agitation.

Secondary Outcome Measures

Systolic pressure
Diastolic pressure
Mean pressure
Heart rate
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.
Delayed emergence
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
The incidence of postoperative delirium
The incidence of postoperative delirium was assessed using CAM Scale.
Postoperative Pain
The Numericrating scale (NRS) is grouped from 0 to 10. The degree of pain increased directly with the score.
Complication
All the perioperative complications are recorded.
Hospitalization time
The length of hospital stay is recorded.
Hospital expenses
Hospitalization costs include total hospitalization costs and anesthesia costs.
30-day all-cause mortality
30-day all-cause mortality is recorded.

Full Information

First Posted
November 7, 2022
Last Updated
November 19, 2022
Sponsor
Second Affiliated Hospital of Nanchang University
Collaborators
Yichang Humanwell Pharmaceutical Co., Ltd., China
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1. Study Identification

Unique Protocol Identification Number
NCT05624424
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 15, 2022 (Anticipated)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Second Affiliated Hospital of Nanchang University
Collaborators
Yichang Humanwell Pharmaceutical Co., Ltd., China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
This is a RCTs.
Masking
ParticipantOutcomes Assessor
Masking Description
Care provider and investigator (anesthesiologist) cannot be blinded for different appearance of remimazolam, propofol and sevoflurane.
Allocation
Randomized
Enrollment
1317 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remimazolam Besylate
Arm Type
Experimental
Arm 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.
Arm Title
Propofol
Arm Type
Active Comparator
Arm 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.
Arm Title
Sevoflurane
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Rematazolam Besylate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sufentanil
Intervention Description
Anesthesia was induced with Sufentanil 0.3~0.5 ug/kg by intravenous injection after the LoC and BIS<60.
Intervention Type
Drug
Intervention Name(s)
Cisatracurium Besylate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Intervention Description
After the LoC, remifentanil 0.1~0.3 ug/kg/min inject intravenously until the end of surgery.
Primary Outcome Measure Information:
Title
The incidence of emergence agitation
Description
The Riker Sedation-Agitation Scale (RSAS) score ≥ 5 points indicates the presence of emergence agitation.
Time Frame
Duration from the time patients awakening to the time of departure from post-anesthesia care unit (PACU), average 1 hour.
Title
The incidence of emergence agitation
Description
The Richmond Agitation-Sedation Scale (RASS) ≥ +1 points indicates the presence of emergence agitation.
Time Frame
Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Secondary Outcome Measure Information:
Title
Systolic pressure
Time Frame
"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".
Title
Diastolic pressure
Time Frame
"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".
Title
Mean pressure
Time Frame
"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".
Title
Heart rate
Time Frame
"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".
Title
Recovery times
Description
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.
Time Frame
Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Title
Delayed emergence
Description
Delayed emergence is defined as failure to shake hands and no significant response to nociceptive stimuli more than 30 minutes after surgery.
Time Frame
Duration from the time patients awakening to the time of departure from PACU, average 1 hour.
Title
The incidence of postoperative delirium
Description
The incidence of postoperative delirium was assessed using CAM Scale.
Time Frame
Record in the mornings on the 1st, 3rd and 7th day after operation.
Title
Postoperative Pain
Description
The Numericrating scale (NRS) is grouped from 0 to 10. The degree of pain increased directly with the score.
Time Frame
Record in the mornings on the 1st, 3rd and 7th day after operation.
Title
Complication
Description
All the perioperative complications are recorded.
Time Frame
During the perioperative period, up to 1 week.
Title
Hospitalization time
Description
The length of hospital stay is recorded.
Time Frame
After the patient is discharged from the hospital, average 1 week.
Title
Hospital expenses
Description
Hospitalization costs include total hospitalization costs and anesthesia costs.
Time Frame
After the patient is discharged from the hospital, average 1 week.
Title
30-day all-cause mortality
Description
30-day all-cause mortality is recorded.
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fuzhou Hua, professor
Phone
+8615170238929
Email
huafuzhou@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Fang
Phone
+8618370985324
Email
ndfangyang@163.com
Facility Information:
Facility Name
People's Hospital of Ganzhou
City
Ganzhou
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guiming Huang, professor
Phone
+8615907977699
Email
liyouchun2007@163.com
Facility Name
the First Affiliated Hospital of Gannan Medical College, Gannan Medical College
City
Ganzhou
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maolin Zhong, professor
Phone
+8613607978802
Email
zml8802@163.com
Facility Name
The First People's Hospital of JiuJiang
City
Jiujiang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shenghong Zhong, professor
Phone
+8613607926616
Email
jjmazui@163.com
Facility Name
the Second Affiliated Hospital of Nanchang University, Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fuzhou Hua, professor
Phone
+8615170238929
Email
huafuzhou@126.com
Facility Name
Tumor Hospital of Jiangxi Province
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huaping Xiao, professor
Phone
+8613507082466
Email
463568985@qq.com
Facility Name
Shangrao People's Hospital
City
Shangrao
State/Province
Jiangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoxiong Lin, professor
Phone
+8613707033801
Email
lgxmaz@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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