drugset / Trial / NCT07649746
Opioid-Free Versus Opioid-Based Sedation for Endoscopic Procedures
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2026-06
- Primary completion
- 2028-02
- Completion
- 2028-02
Publications
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Remifentanil | Small molecule | 0.01 ug/kg | — |
| Comparator | Remifentanil | Small molecule | 0.03 ug/kg | — |
| Background | Dexmedetomidine | Other / unclassified | 0.7 ug/kg | — |
Indications
No indication recorded.