Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-15

Study Completion Date

2023-10-31

Brief Summary

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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.

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Detailed Description

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1. 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.
2. 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.
3. 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.

Conditions

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Analgesics，Opioid Bariatric Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type OTHER

Opioid free anesthesia technology

Intervention Type PROCEDURE

We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.

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.

Group Type EXPERIMENTAL

Opioid free anesthesia technology

Intervention Type PROCEDURE

We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.

Interventions

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Opioid free anesthesia technology

We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. ASA grade I \~ III;
2. Age from 18 - 65 years old;
3. BMI ≥ 35kg / m2 in patients with OSA to undergo bariatric surgery；（4 provide written informed consent for participation.

Exclusion Criteria

1. Age \< 18 years or age \>65 years old;
2. Pregnancy test was positive;
3. Patients with a history of drug abuse or dependence on opioids;
4. Patients with chronic pain or severe heart, lung, liver or nervous system diseases

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes