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

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

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.

Study Overview

• Status: Completed
• Conditions: Long-term-opioid-free Anesthesia
• Intervention / Treatment: Drug: Remifentanil Hydrochloride; Drug: Sufentanil Citrate

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Department of Anesthesiology, West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Ren Liao, M.D, West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 20, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Remifentanil; Sufentanil; Dsuvia
• Other Study ID Numbers: WCH20220916

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No