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

NCT06385756 | Not Yet Recruiting Phase 4

• 1 other identifier: TJ-IRB202403020
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Anesthesia induction; Perioperative Adverse Reactions; Gynecological Laparoscopic Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• MAP at different time points

  Up to 3 hours

• Incidence of postoperative nausea and vomiting (ponv)

  24 hours

Study Arms (2)

amobarbital-propofol group

EXPERIMENTAL

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

Drug: Amobarbital; Drug: Propofol

propofol group

PLACEBO COMPARATOR

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

Drug: Propofol

Interventions

Amobarbital DRUG

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.

amobarbital-propofol group

Propofol DRUG

propofol

amobarbital-propofol group; propofol group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Interventions

Amobarbital; Propofol

Intervention Hierarchy (Ancestors)

Barbiturates; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 26, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 22, 2024

Record last verified: 2024-05