Multimodal Analgesic Management of Naborphine Combined With Opioid Free Under General Anesthesia in OSA Patients Undergoing Weight Loss Surgery Under the Concept of ERAS: a Prospective, Randomized, Parallel Controlled Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- postoperative NRS score
Study Overview
Brief Summary
Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest clinical anesthetic drugs.
Detailed Description
- The concept of enhanced recovery after surgery (ERAS) has been applied in the perioperative period of many operations. Reducing the dosage of opioids is an important part of the concept of ERAS.
- Opioid free anesthesia technology has been recognized in reducing nausea and vomiting, but whether it can meet the perioperative analgesic needs of patients undergoing bariatric surgery and obtain more clinical benefits still has no research supportment.
- This study is expected to clarify the clinical effect of opioid free anesthesia technology in perioperative analgesia management of morbid obesity patients with moderate and severe OSA, reduce adverse events, and explore the latest clinical anesthesia scheme.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •ASA grade I ~ III;
- •Age from 18 - 65 years old;
- •BMI ≥ 35kg / m2 in patients with OSA to undergo bariatric surgery； （4 provide written informed consent for participation.
Exclusion Criteria
- •Age < 18 years or age >65 years old;
- •Pregnancy test was positive;
- •Patients with a history of drug abuse or dependence on opioids;
- •Patients with chronic pain or severe heart, lung, liver or nervous system diseases
Arms & Interventions
Opioid anesthesia group
Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, sufentanil 0.3μg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and remifentanil 0.2-0.5 μg/kg·min to maintain anesthesia. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and sufentanil 10 μg will be given after surgery. For PCA, sufentanil 2μg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg.
Intervention: Opioid free anesthesia technology (Procedure)
Opioid free anesthesia group
Anesthesia induction with propofol 2.5mg/kg, rocuronium bromide 0.6mg/kg, naborphine 0.2mg/kg，esketamine 0.3mg/kg, intubation was performed when BIS value reached 40-60. Intraoperative pump injection of propofol 4-12 mg/kg·h and esketamine 0.3～0.5mg/kg·h. Ultrasound-guided transversus abdominis plane block (with 0.375% ropivacaine 40ml) will be implemented preoperatively. Ondansetron 8mg and naborphine 0.2mg/kg will be given after surgery. For PCA, naborphine 2mg/kg + dexmedetomidine 2μg/kg + ondansetron 24mg.
Intervention: Opioid free anesthesia technology (Procedure)
Outcomes
Primary Outcomes
postoperative NRS score
Time Frame: Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.
A subjective psychometric response scale used to measure distinct behavioral or physiological phenomena based on linear numerical gradient or yes/no alternatives. The Numeric Pain Scale (NRS) pain numerical score(0-10 score, 0: no pain, 10: worst imaginable pain). A pain measurement list about quiet NRS score and cough NRS score at different postoperative time will be used.
Secondary Outcomes
- Hemodynamic fluctuation(From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 hours.)
- Rate of postoperative nausea and vomiting(It takes about 24 hours.)
- Dosage of remedial analgesics postoperatively(It takes about 24 hours.)
- The levels of C-reactive protein (CRP)(It takes about 24 hours.)
- recovery time(It will take up to 1 hour or 2 hours.)
- The levels of cortisol (COR).(It takes about 24 hours.)
- The levels of blood glucose (BG)(It takes about 24 hours.)
- The levels of interleukin-6 (IL-6).(It takes about 24 hours.)
- Ramsay scale(Score from the end of the operation and follow-up at the time point specified in the scoring form for a total of 27 hours.)
- Scores of 15-item Quality of Recovery (QoR-15) scale 24 hours postoperatively of participants.(One day after the surgery.)
- Acceptability of participants with laryngeal mask 24 hours after surgery.(One day after the surgery.)
Investigators
Lili Cao
Professor
Qianfoshan Hospital