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ClinicalTrials.gov ID

NCT05624424

Lead Sponsor

Second Affiliated Hospital of Nanchang UniversityOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 4

Enrollment

1,317Estimated

Last Update Posted

Nov 22, 2022Actual

Start Date

Nov 15, 2022Estimated

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Oct 31, 2023Estimated

Official Title

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

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.

• Emergence Agitation
• Remimazolam Besylate
• Perioperative Sedation
• Laparoscopic Abdominal Surgery
• Anesthesia, General

• Rematazolam Besylate
• Propofol
• Sevoflurane
• Sufentanil
• Cisatracurium Besylate
• Remifentanil

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

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;

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Second Affiliated Hospital of Nanchang UniversityOTHER

Collaborators

Yichang Humanwell Pharmaceutical Co., Ltd., ChinaINDUSTRY

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