Long-term-opioid-free Anesthesia in Anterior Cervical Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Safety and Efficacy of Long-term-opioid-free Anesthesia in Anterior Cervical Surgery: a Prospective Randomized Controlled Trial

Conditions
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Long-term-opioid-free Anesthesia

Intervention / Treatment
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* Drug: Remifentanil Hydrochloride
* Drug: Sufentanil Citrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing anterior cervical surgery., sign the informed consent form Age above 18 years old ASA Ⅰ-Ⅲ. Exclusion Criteria: Pregnant or lactating women. Patients with history of drug abuse, including but not limited to opioids, amphetamines, ketamine, etc Allergic to the materials or drugs used in this study. Patients with current/previous gastrointestinal bleeding and gastric ulcers; Have history of nervous system diseases such as peripheral neuropathy, or psychiatric mental illness. Other conditions that the investigators consider unsuitable for participation in the study, such as deaf, Parkinson's disease, and difficult to communication etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-term-opioid-free anesthesia group.<br> | Drug: Remifentanil Hydrochloride<br>* Subjects will receive remifentanil anesthesia for operative analgesia.<br>|
| Active Comparator: Long-term-opioid anesthesia group.<br> | Drug: Sufentanil Citrate<br>* Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative numerical rating scales (NRS) at rest. | Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery. | Up to 48 hours after operation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post operative nausea and vomiting (PONV). | The proportion of subjects who experienced PONV. | Up to 30 days after operation. | 
| Postoperative NRS on movement. | Postoperative NRS pain score on movement, up to 48hr. | Up to 48 hours after operation. | 
| Postoperative complications. | Incidence of postoperative adverse reactions and complications. | Up to 30 days after operation. | 
| Incidence of intraoperative adverse events. |  | Intraoperative . | 
| Postoperative recovery of cervical spine function | Japanese Orthopaedic Association Scores.(JOA scores). | Up to 48 hours after operation. | 
| Analgesic medication use before discharge。 |  | Up to 48 hours after operation. | 
| Length of stay (LOS) in hospital | Time frame from the day of hospital admission to discharge from the hospital (unit: days). | Up to 30 days after operation. | 
| Postoperative LOS | Time frame from the day of operation to discharge from the hospital (unit: days). | Up to 30 days after operation. | 
| Total in-hospital cost. | Total hospitalization expenses after the destruction of costly consumables in orthopedic operation. | Up to 30 days after operation. |