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

NCT05548465 | Completed

• 1 other identifier: WCH20220916
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Long-term-opioid-free Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Incidence of post operative nausea and vomiting (PONV).

  Up to 30 days after operation.

• Postoperative NRS on movement.

  Up to 48 hours after operation.

• Postoperative complications.

  Up to 30 days after operation.

• Incidence of intraoperative adverse events.

  Intraoperative .

• Postoperative recovery of cervical spine function

  Up to 48 hours after operation.

Study Arms (2)

Long-term-opioid-free anesthesia group.

EXPERIMENTAL

Drug: Remifentanil Hydrochloride

Long-term-opioid anesthesia group.

ACTIVE COMPARATOR

Drug: Sufentanil Citrate

Interventions

Remifentanil Hydrochloride DRUG

Subjects will receive remifentanil anesthesia for operative analgesia.

Long-term-opioid-free anesthesia group.

Sufentanil Citrate DRUG

Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.

Long-term-opioid anesthesia group.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing anterior cervical surgery., sign the "informed consent form"
• Age above 18 years old
• ASA Ⅰ-Ⅲ.

You may not qualify if:

• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

Department of Anesthesiology, West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

Remifentanil; Sufentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fentanyl

Study Officials

• Ren Liao, M.D

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: September 26, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)