The Safety of Etomidate - Propofol Mixture vs Propofol in Total Intravenous Anesthesia During Abdominal Surgery

NCT05810363 | Completed

• 1 other identifier: SEPT
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to access the safety of etomidate - propofol mixture vs propofol in total intravenous anesthesia during abdominal surgery.

Conditions

Etomidate; Hypotension

Outcome Measures

Primary Outcomes (1)

• Incidence and duration of hypotension during anesthesia

  Systolic blood pressure ≤90 mmHg, or \> 20% reduction from baseline, or mean arterial pressure \<65 mmHg, from the time when anesthesia induction began to the time before the patient complied with transfer out of PACU

  during anesthesia

Secondary Outcomes (4)

• Success rate of sedation

  during anesthesia

• Recovery time

  during anesthesia

• The type and dosage of vasoactive drugs used during operation

  during anesthesia

• The incidence of postoperative nausea and vomiting

  72 hours after surgery

Study Arms (2)

EP group

EXPERIMENTAL

Patients in this group will receive etomidate- propofol mixture during induction and maintenance.

Drug: Etomidate - propofol mixture

P group

EXPERIMENTAL

Patients in this group will receive propofol during induction and maintenance.

Drug: Propofol

Interventions

Etomidate - propofol mixture DRUG

Patients will receive etomidate - propofol mixture during induction and maintenance. Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，EP mixture（E：P=1:2） 0.1-0.25 ml/kg for induction, EP mixture 0.4\~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min \~0.3 μg/kg/min for maintenance.

Also known as: EP

EP group

Propofol DRUG

Patients will receive propofol during induction and maintenance.Sufentanil 0.2-0.7 μg/kg，Cisatracurium 0.15 mg/kg，propofol 0.1-0.25 ml/kg for induction, propofol 0.4\~ 1.2 ml/kg/h and remifentanil 0.05μg/kg/min \~0.3 μg/kg/min for maintenance.

Also known as: P

P group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA Ⅰ\~Ⅲ;
• BMI was 18-28 kg/m2;
• For elective abdominal surgery under intravenous general anesthesia;
• The expected duration of anesthesia was 1 to 4 hours.

You may not qualify if:

• Pregnant patients;
• Septic shock and multiple organ failure diagnosed within 14 days;
• Hyperkalemia (serum potassium \>5.5mmol/L) within 48 hours;
• Stroke or transient ischemic attack within 3 months;
• Patients with unstable angina pectoris or myocardial infarction within 3 months; Arrhythmia requiring treatment was not treated or treatment did not meet expectations;
• Patients with preoperative diagnosed diabetes mellitus and uncontrolled blood glucose; Diabetic complications were diagnosed before surgery, including diabetic ketoacidosis, hyperosmolar coma, diabetes-related infection, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic neuropathy, diabetic foot, etc.
• Severe liver and renal dysfunction;
• Liver surgery, renal surgery, adrenal surgery, day surgery;
• Resting blood pressure ≥180/110 mmHg (2020 ISH hypertension guideline ≥ grade 3 hypertension); Or systolic blood pressure \<90mmHg or mean blood pressure \<65mmHg.
• Taking corticosteroids or other immunosuppressants for more than 10 days within 6 months or having a history of adrenal cortex suppression or immune system diseases;
• Patients who participated in other drug trials within 3 months;
• Patients with disturbance of consciousness or other mental diseases;
• Confirmed/suspected abuse or long-term use of narcotic sedatives and analgesics；
• Patients with cancer who received neoadjuvant therapy or chemotherapy before surgery;
• Allergic to the drug used in this trial and its components.

Sponsors & Collaborators

• Ailin Luo: lead

Study Sites (1)

Tongji hospital

Wuhan, China

Location

MeSH Terms

Conditions

Hypotension

Interventions

Propofol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Ailin Luo, Dr

  Department of Anesthesiology of Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 12, 2023
• Study Start: June 16, 2023
• Primary Completion: June 17, 2024
• Study Completion: October 30, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)