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Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures

ConditionsSedationEndoscopyColonoscopyEndoscopic Retrograde Cholangiopancreatography (ERCP)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 85 years

ASA physical status I-III

Scheduled for ERCP, gastroscopy, or colonoscopy

Disqualifiers

Refusal to participate in the study

Inability to communicate

Alcohol or substance abuse

Neuropsychiatric disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine (Opioid-Free)Experimental treatment 1 intervention
Group B: Remifentanil + DexmedetomidineActive comparator 2 interventions

Trial outcomes

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.

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

Secondary outcomes

1

Quality of Recovery (QoR-15) Score

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.

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

Patient Satisfaction Score

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.

Time frame
Within 1 hour after the procedure, before discharge from the recovery area
3

Surgeon Satisfaction Score

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.

Time frame
Immediately after the procedure
4

Recovery Nurse Satisfaction Score

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.

Time frame
During the recovery period, before discharge

Other outcomes

1

Pain and Analgesic Outcomes

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.

Time frame
During the recovery period before discharge
2

Post-Anesthesia Care Unit (PACU) Requirement

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.

Time frame
Immediately after the procedure
3

Heart Rate

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.

Time frame
Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
4

Mean Arterial Pressure (MAP)

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.

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Lead sponsor

Source ClinicalTrials.gov

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