Long-term-opioid-free Anesthesia in Anterior Cervical Surgery
Study Details
Study Description
Brief Summary
We design this randomized controlled trial to explore the safety and efficacy of the long-term-opioid-free anesthesia in anterior cervical surgery, to reduce the dosage of perioperative long-acting opioids and promoting patients'rehabilitation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Long-term-opioid-free anesthesia group.
|
Drug: Remifentanil Hydrochloride
Subjects will receive remifentanil anesthesia for operative analgesia.
|
| Active Comparator: Long-term-opioid anesthesia group.
|
Drug: Sufentanil Citrate
Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.
|
Outcome Measures
Primary Outcome Measures
- Postoperative numerical rating scales (NRS) at rest. [Up to 48 hours after operation.]
Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery.
Secondary Outcome Measures
- Incidence of post operative nausea and vomiting (PONV). [Up to 30 days after operation.]
The proportion of subjects who experienced PONV.
- Postoperative NRS on movement. [Up to 48 hours after operation.]
Postoperative NRS pain score on movement, up to 48hr.
- Postoperative complications. [Up to 30 days after operation.]
Incidence of postoperative adverse reactions and complications.
- Incidence of intraoperative adverse events. [Intraoperative .]
- Postoperative recovery of cervical spine function [Up to 48 hours after operation.]
Japanese Orthopaedic Association Scores.(JOA scores).
- Analgesic medication use before discharge。 [Up to 48 hours after operation.]
- Length of stay (LOS) in hospital [Up to 30 days after operation.]
Time frame from the day of hospital admission to discharge from the hospital (unit: days).
- Postoperative LOS [Up to 30 days after operation.]
Time frame from the day of operation to discharge from the hospital (unit: days).
- Total in-hospital cost. [Up to 30 days after operation.]
Total hospitalization expenses after the destruction of costly consumables in orthopedic operation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients undergoing anterior cervical surgery., sign the "informed consent form"
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Age above 18 years old
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ASA Ⅰ-Ⅲ.
Exclusion Criteria:
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Pregnant or lactating women.
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Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc
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Allergic to the materials or drugs used in this study.
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Patients with current/previous gastrointestinal bleeding and gastric ulcers;
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Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness.
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Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Anesthesiology, West China Hospital, Sichuan University | Chengdu | Sichuan | China | 610041 |
Sponsors and Collaborators
- West China Hospital
Investigators
- Principal Investigator: Ren Liao, M.D, West China Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- WCH20220916