MedTrace Logo

Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

NCT07649746 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-06-16

No results posted yet for this study

Summary

This study will compare two different sedation approaches used during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). One group will receive dexmedetomidine alone (opioid-free sedation), while the other group will receive dexmedetomidine combined with remifentanil (opioid-based sedation).

The purpose of the study is to determine whether an opioid-free sedation approach can reduce opioid-related adverse symptoms, such as nausea, vomiting, dizziness, drowsiness, dry mouth, headache, and fatigue. The study will also evaluate quality of recovery, patient and healthcare staff satisfaction, hemodynamic effects, complications, and time to discharge after the procedure.

Conditions

  • Sedation
  • Endoscopy
  • Colonoscopy
  • Endoscopic Retrograde Cholangiopancreatography (ERCP)

Interventions

DRUG

Dexmedetomidine

Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.

DRUG

Remifentanil

Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.

Sponsors & Collaborators

  • Bakirkoy Dr. Sadi Konuk Research and Training Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-02-29
Completion
2028-02-29

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649746 on ClinicalTrials.gov