Safety of Etomidate-propofol Mixture vs. Propofol for Total Intravenous Anesthesia in Elderly Patients Undergoing Abdominal Surgery

NCT07019246 | Recruiting

• 1 other identifier: SEPTE
• Study Type: interventional
• Target: 166
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Etomidate Combined With Propofol; Hypertension

Outcome Measures

Primary Outcomes (1)

• Incidence and duration of hypotension during anesthesia

  Blood pressure fluctuations greater than 10% relative to baseline values

  day 1 (The time from the start of anesthesia induction to extubation)

Secondary Outcomes (5)

• Success rate of sedation

  day 1 (The time from the start of anesthesia induction to extubation)

• Recovery time

  Day 1 (Time from drug withdrawal to extubation)

• The type and dosage of vasoactive drugs used during operation

  day 1 (The time from the start of anesthesia induction to extubation)

• The incidence of postoperative nausea and vomiting

  within 72 hours after surgery

• The incidence of in-hospital complications after surgery

  Perioperative

Study Arms (2)

EP group

EXPERIMENTAL

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

Drug: EP mixture

P group

ACTIVE COMPARATOR

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

Drug: Propofol

Interventions

EP 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.

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.

P group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: 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:

• 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;

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Propofol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Shiyong Li

  Department of Anesthesiology of Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shiyong Li

CONTACT

02783665480; shiyongli@hust.edu.cn

Qiang Han, 02783665480

CONTACT

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 13, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 5, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)