Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

NCT07649746 | Not Yet Recruiting

• 1 other identifier: 2024-KAEK-31
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Dexmedetomidine; Opioid-Free Sedation; Remifentanil; Sedation; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Incidence of Opioid-Related Adverse Symptoms

  Incidence of opioid-related adverse symptoms including nausea, vomiting, difficulty concentrating, difficulty staying awake, dizziness, sleepiness, general fatigue or weakness, pruritus, dry mouth, and headache. The occurrence of one or more symptoms will be recorded and compared between the opioid-free and opioid-based sedation groups.

  Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours

Secondary Outcomes (4)

• Quality of Recovery (QoR-15) Score

  Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area

• Patient Satisfaction Score

  Within 1 hour after the procedure, before discharge from the recovery area

• Surgeon Satisfaction Score

  Immediately after the procedure

• Recovery Nurse Satisfaction Score

  During the recovery period, before discharge

Other Outcomes (6)

• Pain and Analgesic Outcomes

  During the recovery period before discharge

• Post-Anesthesia Care Unit (PACU) Requirement

  Immediately after the procedure

• Heart Rate

  Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours

Study Arms (2)

Dexmedetomidine (Opioid-Free)

EXPERIMENTAL

Participants will receive dexmedetomidine infusion for procedural sedation. Dexmedetomidine infusion will be initiated at 0.7 mcg/kg/h. Five minutes later, a placebo infusion (100 mL isotonic saline) will be started. Sedation will be induced with propofol 1.5 mg/kg IV bolus and maintained according to the study protocol.

Drug: Dexmedetomidine

Remifentanil + Dexmedetomidine

ACTIVE COMPARATOR

Participants will receive dexmedetomidine infusion at 0.7 mcg/kg/h. Five minutes later, remifentanil infusion will be initiated at 0.01-0.03 mcg/kg/min. Sedation will be induced with propofol 1.5 mg/kg IV bolus and maintained according to the study protocol.

Drug: Dexmedetomidine; Drug: Remifentanil

Interventions

Dexmedetomidine DRUG

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

Dexmedetomidine (Opioid-Free); Remifentanil + Dexmedetomidine

Remifentanil DRUG

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

Remifentanil + Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 85 years
• ASA physical status I-III
• Scheduled for ERCP, gastroscopy, or colonoscopy

You may not qualify if:

• Refusal to participate in the study
• Inability to communicate
• Alcohol or substance abuse
• Neuropsychiatric disease
• Severe respiratory failure
• Severe heart failure
• Pregnancy
• Body mass index (BMI) \>30 kg/m²
• Hearing impairment
• History of allergy to study medications
• Requirement for orotracheal intubation or general anesthesia
• Procedures lasting less than 20 minutes

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Related Publications (2)

• Yu JM, Tao QY, He Y, Liu D, Niu JY, Zhang Y. Opioid-Free Anesthesia for Pain Relief After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial. J Pain Res. 2023 Oct 30;16:3625-3632. doi: 10.2147/JPR.S432601. eCollection 2023.

  PMID: 37928062 BACKGROUND

• Hao C, Xu H, Du J, Zhang T, Zhang X, Zhao Z, Luan H. Impact of Opioid-Free Anesthesia on Postoperative Quality of Recovery in Patients After Laparoscopic Cholecystectomy-A Randomized Controlled Trial. Drug Des Devel Ther. 2023 Nov 28;17:3539-3547. doi: 10.2147/DDDT.S439674. eCollection 2023.

  PMID: 38046284 BACKGROUND

MeSH Terms

Interventions

Dexmedetomidine; Remifentanil

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines

Central Study Contacts

Tuğba Yücel Yenice, MD

CONTACT

+90 212 414 71 71; tugbayucel09@gmail.com

Sevim Bahar Bedirhan, MD

CONTACT

+90 212 414 71 71; sbbedirhan@gmail.com

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 GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomly assigned to one of two parallel groups. Group I will receive dexmedetomidine alone (opioid-free sedation), and Group II will receive dexmedetomidine combined with remifentanil (opioid-based sedation) during gastroscopy, colonoscopy, or ERCP procedures. Outcomes will be compared between the two groups.

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share