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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05624424
Other study ID # 2022-EA-2
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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;

Study Design


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
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