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

Tongji Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Amobarbital Sodium; Hemodynamics Instability

Treatments: Drug: Amobarbital; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT06385756

TJ-IRB202403020

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

amobarbital-propofol group

Experimental group

Description:

Participants were given amobarbital sodium 1 mg/kg 1 min before induction and propofol 1.5mg /kg following.

Treatment:

Drug: Propofol

Drug: Amobarbital

propofol group

Placebo Comparator group

Description:

The propofol group was given the same volume of normal saline 1 min before induction, followed by propofol 2.5mg /kg.

Treatment:

Drug: Propofol