Effectiveness of adjunct loading dose of dexmedetomidine to propofol-based sedation to reduce incidence of hypoxia in ERCP

Effectiveness of adjunct loading dose of dexmedetomidine to propofol-based sedation to reduce incidence of hypoxia in ERCP : A double blind randomized controlled trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250914006

Enrollment

Registered

2025-09-14

Start date

2025-09-02

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Hypoxia in patients undergoing ERCP under propofol based sedation ERCP, Dexmedetomodine, hypoxia, sedation, RCT, Randomized controlled trial

Interventions

Patients scheduled for elective ERCP at Srinagarind Hospital will be screened by a researcher who is not involved in their clinical care. Those who meet the inclusion criteria will be informed about t

Experimental Drug,Active Comparator Drug

Dexmedetomidine - propofol sedation,Propofol sedation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients who plan to undergo elective ERCP under sedation. 2. Admitted to inpatient wards. 3. Age 18-75 years old. 4.ASA physical status 1-3.

Exclusion criteria

Exclusion criteria: 1. Refuse to participate 2. Significant heart diseases (valvular heart disease, coronary artery disease, arrhythmia, 3. Extreme BMI (>30 or <18 kg/m2). 4. Uncontrolled lung diseases (uncontrolled asthma, uncontrolled COPD, interstitial lung disease with functional class <I). 5. Allergy to study drugs; dexmedetomidine, propofol, fentanyl, glycopyrrolate, atropine, ephedrine or norepinephrine. 6. Patient with risk of aspiration or difficult airway. 7. Severe renal and liver impairment. 8. Drug abuse. 9. Pregnancy or lactation. 10. Acute illness prior to sedation (causing postponed operation).

Design outcomes

Primary

Measure	Time frame
hypoxia incidence during procedure pulse oxymetry	—

Secondary

Measure	Time frame
Total propofol dose right after procedure infusion device,procedural time right after procedure timer,Recovery time 30 min after procedure modified aldrete score,patients satisfaction 30 min after procedure numerical rating scale,scopist satisfaction 30 min after procedure numerical rating scale,Sedation related- side effects including PONV, hypotension, bradycardia, arrhythmia, airway manipulation during procedure PONV grading scale and vital sign	—

Measure

Time frame

Total propofol dose right after procedure infusion device,procedural time right after procedure timer,Recovery time 30 min after procedure modified aldrete score,patients satisfaction 30 min after procedure numerical rating scale,scopist satisfaction 30 min after procedure numerical rating scale,Sedation related- side effects including PONV, hypotension, bradycardia, arrhythmia, airway manipulation during procedure PONV grading scale and vital sign

—

Countries

Thailand

Contacts

Public ContactSiwakorn Pradabkorn

Khonkaen university

siwakornp@kkumail.com0895945365

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026