NCT05624424

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,317 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
DRUG	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.
DRUG	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.
DRUG	Sufentanil	Anesthesia was induced with Sufentanil 0.3\~0.5 ug/kg by intravenous injection after the LoC and BIS\<60.
DRUG	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.
DRUG	Remifentanil	After the LoC, remifentanil 0.1\~0.3 ug/kg/min inject intravenously until the end of surgery.

Timeline

• Start date: 2022-11-15
• Primary completion: 2023-10-31
• Completion: 2023-10-31
• First posted: 2022-11-22
• Last updated: 2022-11-22

Locations

6 sites across 1 country: China