Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
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
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tuğba Yücel Yenice, MD
- 전화번호: +90 212 414 71 71
- 이메일: tugbayucel09@gmail.com
연구 연락처 백업
- 이름: Sevim Bahar Bedirhan, MD
- 전화번호: +90 212 414 71 71
- 이메일: sbbedirhan@gmail.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Dexmedetomidine (Opioid-Free)
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.
|
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
|
|
활성 비교기: Remifentanil + Dexmedetomidine
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.
|
Dexmedetomidine 200 mcg diluted in 100 mL isotonic saline and administered according to the study protocol.
Remifentanil 5 mg diluted in 100 mL isotonic saline and administered according to the study protocol.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of Opioid-Related Adverse Symptoms
기간: 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.
|
Perioperative/Periprocedural: from procedure start through recovery room discharge, approximately 2-4 hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of Recovery (QoR-15) Score
기간: 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.
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Baseline (before the procedure) and within 2 hours after the procedure, before discharge from the recovery area
|
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Patient Satisfaction Score
기간: 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.
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Within 1 hour after the procedure, before discharge from the recovery area
|
|
Surgeon Satisfaction Score
기간: 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.
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Immediately after the procedure
|
|
Recovery Nurse Satisfaction Score
기간: 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.
|
During the recovery period, before discharge
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Pain and Analgesic Outcomes
기간: 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.
|
During the recovery period before discharge
|
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Post-Anesthesia Care Unit (PACU) Requirement
기간: 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.
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Immediately after the procedure
|
|
Heart Rate
기간: 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.
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Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
|
|
Mean Arterial Pressure (MAP)
기간: 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.
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Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
|
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Oxygen Saturation (SpO2)
기간: 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.
|
Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
|
|
Ramsay Sedation Scale Score
기간: 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) |
Perioperative/Periprocedural, at 6 predefined time points over approximately 1-3 hours
|
공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2024-KAEK-31 (Sisli Hamidiye Etfal Training and Research Hospital Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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