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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: October 31, 2023

Interventions

  • Drug: Remifentanil Hydrochloride
    • Subjects will receive remifentanil anesthesia for operative analgesia.
  • Drug: Sufentanil Citrate
    • Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.

Arms, Groups and Cohorts

  • Experimental: Long-term-opioid-free anesthesia group.
  • Active Comparator: Long-term-opioid anesthesia group.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • West China Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ren Liao, professor – West China Hospital
  • Overall Official(s)
    • Ren Liao, M.D, Principal Investigator, West China Hospital

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