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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07079176
Enrollment
732
Registered
2025-07-22
Start date
2025-08-01
Completion date
2028-04-30
Last updated
2025-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Endoscopy

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 .

Interventions

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.

DRUGpropofol

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.

Sponsors

RenJi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
The risk of hypoxemiaduring sedated gastrointestinal endoscopy

Contacts

Primary ContactPan ZY
rshjsh@163.com021-58752345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026