Effect of Rematazolam Besylate, Propofol, and Sevoflurane Perioperative Sedation on Incidence of Emergence Agitation and Hemodynamics in Patients Undergoing Laparoscopic Abdominal Surgery
NCT ID: NCT05624424
Last Updated: 2022-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
1317 participants
INTERVENTIONAL
2022-11-15
2023-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Remimazolam vs Sevoflurane Anesthesia on Incidence of Emergence Agitation and Complications in Children Undergoing Ophthalmic Surgery
NCT05527314
A Comparison Between Propofol-Remifentanil and Midazolam-Remifentanil Sedation in the Intensive Care Unit
NCT01527903
Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery
NCT06205719
Comparison of Intravenous Anesthetics to Volatile Anesthetics on Postoperative Cognitive Dysfunction
NCT01809041
the Research of Analgesia and Sedation Effect of Remifentanil on ICU Short Operation
NCT02635802
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Remimazolam 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.
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.
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.
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
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.
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.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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;
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Yichang Humanwell Pharmaceutical Co., Ltd., China
INDUSTRY
Second Affiliated Hospital of Nanchang University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fuzhou Hua
Chief Physician
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-EA-2
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.