Etomidate Combined With Propofol Versus Propofol for Sedation in High-Altitude Patients During Gastroscopy: a Randomized Multicenter Clinical Trial

NCT07079176 | Not Yet Recruiting

• 1 other identifier: 2025-6-20
• Study Type: interventional
• Target: 732
• Locations: 0 countries
• Sites: N/A

Brief Summary

One of the most common adverse events during sedated gastrointestinal endoscopy is hypoxemia, which can lead to serious consequences. When sedated gastrointestinal endoscopy is performed in high-altitude regions with thin air and lower atmospheric pressure, the risk of hypoxemia in patients significantly increases. Traditionally, propofol is the primary agent for sedation during gastrointestinal endoscopy, offering rapid onset and recovery. However, propofol has many side effects, the most important of which is inhibition of respiration and hypotension. Etomidate has less effect on respiration compared to propofol. But there are also adverse reactions of etomidate such as muscular tremor, nausea and vomiting. This study aims to explore whether the etomidate combined with propofol anesthesia method can reduce the risk of hypoxemia during sedated gastrointestinal endoscopy in high-altitude regions, compared to the traditional propofol anesthesia method .

Conditions

Gastrointestinal Endoscopy

Outcome Measures

Primary Outcomes (1)

• The risk of hypoxemia

  during sedated gastrointestinal endoscopy

Study Arms (2)

EP group

EXPERIMENTAL

Drug: etomidate combined with propofol

P group

ACTIVE COMPARATOR

Drug: propofol

Interventions

etomidate combined with propofol DRUG

Patients initially received oxygen via nasal cannula at 5 L/min. All patients underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the EP group, patients received 50 μg fentanyl, followed by a slow intravenous injection of a propofol-etomidate mixture (10 mL:20 mg etomidate + 10 mL:100 mg propofol) at 0.1-0.2 mL/kg. Supplemental doses of 0.05 mL/kg were administered as needed to maintain sedation throughout the procedure.

EP group

propofol DRUG

Patients initially received oxygen via nasal cannula at 5 L/min. All underwent routine noninvasive monitoring of blood pressure, ECG, and oxygen saturation. In the P group, 50 μg fentanyl was administered, followed by a slow intravenous injection of propofol (1-2 mg/kg) after 3 minutes. Supplemental doses of 0.5 mg/kg were administered as needed to maintain sedation throughout the procedure.

P group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 ≤ years ≤ 70 Patients undergoing pain-free gastroscopy or treatment Endoscopy duration within 30 minutes Informed consent obtained from patient or family member

You may not qualify if:

• Concomitant diagnosis of cardiac diseases (e.g., heart failure, angina, myocardial infarction, arrhythmia) Diagnosed pulmonary diseases Liver diseases Kidney diseases Intracranial hypertension ASA class III or higher Concomitant active upper respiratory tract infection

Sponsors & Collaborators

• RenJi Hospital: lead

Related Links

• Related Info

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Pan ZY

CONTACT

021-58752345; rshjsh@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: July 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07