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

West China Hospital100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

100

Conditions

Long-term-opioid-free Anesthesia

Interventions

Remifentanil HydrochlorideDRUG

Subjects will receive remifentanil anesthesia for operative analgesia.

Sufentanil CitrateDRUG

Subjects will receive sufentanil and remifentanil anesthesia for operative analgesia.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Anesthesiology, West China Hospital, Sichuan University

Chengdu, Sichuan, China

Outcomes

Primary Outcomes

Postoperative numerical rating scales (NRS) at rest.

Resting NRS pain scores at 30 min, 2 h, 6 h, 24 h, 48 h after surgery.

Time frame: Up to 48 hours after operation.

Secondary Outcomes

Incidence of post operative nausea and vomiting (PONV).

The proportion of subjects who experienced PONV.

Time frame: Up to 30 days after operation.

Postoperative NRS on movement.

Postoperative NRS pain score on movement, up to 48hr.

Time frame: Up to 48 hours after operation.

Postoperative complications.

Incidence of postoperative adverse reactions and complications.

Time frame: Up to 30 days after operation.

Incidence of intraoperative adverse events.

Time frame: Intraoperative .

Postoperative recovery of cervical spine function

Japanese Orthopaedic Association Scores.(JOA scores).

Time frame: Up to 48 hours after operation.

Analgesic medication use before discharge。

Time frame: 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).

Time frame: Up to 30 days after operation.

Postoperative LOS

Data from ClinicalTrials.gov

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