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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemodynamics Instability; Amobarbital Sodium
• Intervention / Treatment: Drug: Propofol; Drug: Amobarbital

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 40~60 years old；
• ASA Class I to II；
• The operation time was 1h~2h；
• BMI 18~25；
• Sign informed consent.

Exclusion Criteria:

• Known allergy to narcotic drugs used in this study;
• Severe pulmonary insufficiency;
• Abnormal liver and kidney function；
• History of severe anemia and hematoporphyrin；
• History of asthma;
• Uncontrolled high blood pressure or diabetes;
• Pregnant and lactating women；
• Accompanied by cognitive impairment or inability to communicate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: amobarbital-propofol group; Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following.	Drug: Propofol; propofol; 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.
Placebo Comparator: propofol group; The propofol group was given the same volume of normal saline 1 min before induction, followed by propofol 2.5mg /kg.	Drug: Propofol; propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure (MAP) during Induction of anesthesia	MAP was recorded as the main index of hemodynamics during anesthesia induction	Up to 3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MAP at different time points	MAP at different time points (including before induction, tracheal intubation, cutting the skin, extubation)	Up to 3 hours
Incidence of postoperative nausea and vomiting (ponv)	The incidence of perioperative adverse reactions (ponv) was recorded	24 hours

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Gynecological Laparoscopic Surgery; Anesthesia induction; Perioperative Adverse Reactions
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; GABA Modulators; GABA Agents; Propofol; Amobarbital
• Other Study ID Numbers: TJ-IRB202403020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No