Clinical trial NCT05386979: Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Analgesics，Opioid
Bariatric Surgery
Keywords: Opioid free anesthesia
Bariatric Surgery
ERAS
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative NRS score
timeFrame: 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.
Secondary outcomes:
measure: Dosage of remedial analgesics postoperatively
timeFrame: It takes about 24 hours.
measure: Hemodynamic fluctuation
timeFrame: From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 hours.
measure: Ramsay scale
timeFrame: 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.
measure: recovery time
timeFrame: It will take up to 1 hour or 2 hours.
measure: The levels of C-reactive protein (CRP)
timeFrame: It takes about 24 hours.
measure: The levels of cortisol (COR).
timeFrame: It takes about 24 hours.
measure: The levels of blood glucose (BG)
timeFrame: It takes about 24 hours.
measure: The levels of interleukin-6 (IL-6).
timeFrame: It takes about 24 hours.
measure: Scores of 15-item Quality of Recovery (QoR-15) scale 24 hours postoperatively of participants.
timeFrame: One day after the surgery.
measure: Rate of postoperative nausea and vomiting
timeFrame: It takes about 24 hours.
measure: Acceptability of participants with laryngeal mask 24 hours after surgery.
timeFrame: One day after the surgery.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Yongtao Sun
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
name: Yongtao Sun, doctor
role: PRINCIPAL_INVESTIGATOR
References: