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

NCT ID: NCT05548465

Last Updated: 2024-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-26
• Study Completion Date: 2023-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Long-term-opioid-free anesthesia group.

Group Type: EXPERIMENTAL

Remifentanil Hydrochloride

Intervention Type: DRUG

Subjects will receive remifentanil anesthesia for operative analgesia.

Long-term-opioid anesthesia group.

Group Type: ACTIVE_COMPARATOR

Sufentanil Citrate

Intervention Type: DRUG

Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.

Interventions

Remifentanil Hydrochloride

Subjects will receive remifentanil anesthesia for operative analgesia.

Intervention Type: DRUG

Sufentanil Citrate

Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ren Liao

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ren Liao, M.D

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Locations

Department of Anesthesiology, West China Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

WCH20220916

Identifier Type: -

Identifier Source: org_study_id