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

Hemodynamics Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06385756
• Other study ID #: TJ-IRB202403020
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 96
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemodynamics Instability

Intervention

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.
• Propofol
propofol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Outcome

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