Opioid-free Anesthesia Protocol on the Quality of Recovery After Neurosurgical Supratentorial Tumor Resection: A Randomized, Controlled, Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- the quality of recovery-15(QoR-15) score on the second day after surgery
Study Overview
Brief Summary
Opioids have many side effects, such as constipation, urinary retention, itchy skin, respiratory depression, and postoperative nausea and vomiting. These side effects can lead to delayed recovery, longer hospital stays, and increased health care costs. Opioid-free anesthesia is the combination of anti-nociceptive drugs to block the different pathways involved in the transmission of nociceptive information, control pain, avoid opioid-related adverse reactions, and promote patient recovery. At present, opioid-free anesthesia is not widely used in craniocerebral surgery in neurosurgery, and the relevant clinical data are extensive. Therefore, the investigators urgently need to conduct a randomized controlled study to provide clinical evidence for the efficacy and safety of opioid-free anesthesia in neurosurgical patients.
Detailed Description
Data sharing plan: The deidentified participant data reported in this study could be made available to researchers upon approval by the corresponding author (Dr. Ruquan Han, ruquan.han@ccmu.edu.cn) immediately after publication. The reasonable request should provide a formal protocol for database use that has been approved by the ethics institutions.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Scheduled to undergo craniotomy for supratentorial tumors with general anesthesia;
- •18 years≤age≤65 years;
- •American Society of Anesthesiologists (ASA) physical status of I to III;
- •Signed informed consent.
Exclusion Criteria
- •Patients with a body mass index (BMI)≥35 kg/m2;
- •Patients with severe hepatic and renal insufficiency;
- •Patients with cognitive dysfunction, aphasia and other states that do not cooperate with the assessment;
- •Preoperative magnetic resonance imaging of the head showed midline displacement >5 mm;
- •Patients undergoing electrophysiological monitoring during surgery;
- •Pregnant or lactating patients.
Arms & Interventions
the opioid-based control group
Intervention: the opioid-based control group (Drug)
the opioid-free anaesthesia group
Intervention: the opioid-free anesthesia group (Drug)
Outcomes
Primary Outcomes
the quality of recovery-15(QoR-15) score on the second day after surgery
Time Frame: on the second day after surgery
Quality of Recovery-15(QoR-15) score, as a tool to evaluate recovery quality during perioperative period. The QoR-15 scale was used to assess patients' postoperative recovery. Each item is scored on a 10-point scale, from 0 (worst recovery) to 150 (best recovery).
Secondary Outcomes
- The QoR-15 score on the 5th day after surgery(on the 5th day after surgery)
- The incidence of nausea and vomiting within 48 hours after surgery(48 hours after surgery)
- The NRS pain score on the second and 5th days after surgery(on the second and 5th days after surgery)
- The sleep quality on the second and 5th days after surgery(on the second and 5th days after surgery)
- The incidence of chronic pain at 3 and 6 months after surgery(at 3 and 6 months after surgery)
Investigators
Ruquan Han
Head of Anesthesiology
Beijing Tiantan Hospital