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NCT Number: NCT07649746

Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

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.

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Key information

Conditions

Sedation Colonoscopy Endoscopic Retrograde Cholangiopancreatography (ERCP) Endoscopy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Safe and comfortable sedation is essential for endoscopic procedures performed outside the operating room. Various sedation strategies have been developed to improve patient safety, procedural conditions, and recovery profiles. Opioids are commonly used as part of sedation regimens; however, opioid administration may be associated with adverse symptoms such as nausea, vomiting, dizziness, drowsiness, difficulty concentrating, fatigue, pruritus, dry mouth, and headache.

This prospective randomized double-blind study will compare dexmedetomidine alone (opioid-free approach) with a combination of dexmedetomidine and remifentanil (opioid-based approach) for sedation during gastroscopy, colonoscopy, and endoscopic retrograde cholangiopancreatography (ERCP). Eighty ASA physical status I-III patients aged 18-80 years will be enrolled at a single center.

Participants will be randomly assigned to one of two study groups using a computer-generated randomization sequence. Study medications will be prepared by an independent anesthesiologist to maintain blinding. In both groups, dexmedetomidine infusion will be administered. The comparison group will additionally receive remifentanil infusion according to the study protocol.

The primary objective is to determine whether the opioid-free approach reduces the incidence of opioid-related adverse symptoms. Secondary objectives include evaluation of postoperative quality of recovery using the QoR-15 questionnaire and assessment of patient, surgeon, and recovery nurse satisfaction. Additional outcomes include hemodynamic parameters, sedation scores, pain scores, rescue analgesic requirements, discharge time, post-anesthesia care unit requirements, and procedure- or anesthesia-related complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Dexmedetomidine

Drug

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

Remifentanil

Drug

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

Primary outcomes

  1. Incidence of Opioid-Related Adverse Symptoms

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

    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.

Secondary outcomes

  1. Quality of Recovery (QoR-15) Score

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

    Postprocedural quality of recovery assessed using the QoR-15 questionnaire. The QoR-15 is a 15-item instrument evaluating five dimensions: physical comfort (5 items), emotional state (4 items), physical independence (2 items), psychological support (2 items), and pain (2 items). Each item is scored 0-10 on a Likert scale; total score ranges from 0 (worst) to 150 (best quality of recovery). Administered to all patients before the procedure (baseline) and after the procedure before discharge.

  2. Patient Satisfaction Score

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

    Patient satisfaction assessed using a verbal rating scale from 1 to 10 (1: not satisfied at all, 10: very satisfied). Administered once after the procedure before discharge from the recovery area.

  3. Surgeon Satisfaction Score

    Time frame: Immediately after the procedure

    Surgeon satisfaction with procedural conditions assessed using a verbal rating scale from 1 to 10 (1: not satisfied at all, 10: very satisfied). Assessed immediately after the procedure.

  4. Recovery Nurse Satisfaction Score

    Time frame: During the recovery period, before discharge

    Recovery nurse satisfaction assessed using a verbal rating scale from 1 to 10 (1: not satisfied at all, 10: very satisfied). Assessed during the recovery period before discharge.

Other outcomes

  1. Pain and Analgesic Outcomes

    Time frame: During the recovery period before discharge

    Postprocedural pain assessed using the Visual Analog Scale (VAS; 0-10). Target VAS <4. Rescue analgesia administered as IV paracetamol 1g; tramadol 50 mg IV if insufficient. Total rescue analgesic consumption recorded.

  2. Post-Anesthesia Care Unit (PACU) Requirement

    Time frame: Immediately after the procedure

    Need for post-anesthesia care unit (PACU) admission following the procedure. Discharge from the recovery unit will be based on the Modified Aldrete Score. The Modified Aldrete Score ranges from 0 to 10, with higher scores indicating better recovery status. Patients with a score of ≥9 will be considered eligible for discharge from the recovery unit.

  3. Heart Rate

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

    Heart rate measured in beats per minute (bpm) at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.

  4. Mean Arterial Pressure (MAP)

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

    Mean arterial pressure measured in millimeters of mercury (mmHg) at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.

  5. Oxygen Saturation (SpO2)

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

    Peripheral oxygen saturation measured as percentage (%) at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.

  6. Ramsay Sedation Scale Score

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

    Sedation depth assessed using the Ramsay Sedation Scale at 6 standardized time points: (1) on arrival to the procedure room, (2) immediately after induction, (3) 3 minutes after procedure start, (4) 15 minutes after procedure start, (5) at the end of the procedure, (6) on arrival to the recovery room.

    Ramsay Sedation Scale (RSS; ranging from 1 to 6, where 1 = anxious/agitated/restless and 6 = no response to stimulus; higher scores indicate deeper sedation)

Study contacts

Contact information is provided by the study sponsor or research team.

Sevim Bahar Bedirhan, MD

CONTACT

[email protected]

+90 212 414 71 71

Tuğba Yücel Yenice, MD

CONTACT

[email protected]

+90 212 414 71 71

Sponsors and collaborators

Lead sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Other Gov

Registry information

Official study title

Evaluation of an Opioid-Free Approach in Sedation Method Selection in Endoscopy Units: A Prospective Randomized Observational Double-Blind Comparison of Dexmedetomidine (Opioid-Free) and Remifentanil-Dexmedetomidine (Opioid-Based) Combination

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 16, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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