NCT06385756

Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions

Effect of Amobarbital Sodium Combined With Low-dose Propofol on Hemodynamics During Induction and Perioperative Adverse Reactions in Gynecological Laparoscopic Surgery

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

At present, there are limited data on perioperative efficacy of barbiturates at home and abroad. The purpose of this clinical trial is to observe the effects of amobarbital sodium combined with low-dose propofol on hemodynamics during induction and perioperative adverse reactions in gynecological laparoscopic surgery patients, and to provide a more reasonable, safe and comfortable anesthesia program for female patients who undergoing laparoscopic surgery. The main questions it aims to answer are: * whether the combination of the two results on more stable hemodynamics during induction in gynecological laparoscopic surgery patients; * whether the incidence of perioperative oxidative stress and inflammation and postoperative nausea and vomiting（ponv） improved after the use of the two combinations of anesthesia induction. Participants will: * Induction of anesthesia with the experimental drug or placebo； * 5 ml of venous blood was retained before, after, and 1 day after surgery for follow-up determination of serum associated factor levels； * To record their vital signs at any point during the anaesthetic process; Serum serological indexes related to oxidative stress and inflammation were determined. The agitation during the recovery period was recorded. The incidence and severity of ponv were recorded at 2h, 2-6h, and 6-24h postoperatively, and the use of palonosetron was also recorded.

Conditions

• Amobarbital Sodium
• Hemodynamics Instability

Interventions

Type	Name	Description
DRUG	Amobarbital	Participants with gynecological laparoscopic surgery who met the trial inclusion criteria were randomly divided into 2 groups. After entering the room, peripheral intravenous infusion was opened and oxygen was absorbed by the mask for 5 L/min. Mean arterial pressure, heart rate and oxygen saturation were routinely monitored. After positioning, the amobarbital-propofol group was given amobarbital sodium 1 mg/kg 1 min before induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 1.5mg /kg for general anesthesia induction. The propofol group was given the same volume of normal saline 1 min before anesthesia induction, followed by Sufentanil 0.5ug /kg, cisatracurium 0.2mg /kg, penehyclidine hydrochloride 0.01mg /kg, propofol 2.5mg /kg.
DRUG	Propofol	propofol

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-04-26
• Last updated: 2024-05-22