Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2022
CompletedStudy Start
First participant enrolled
May 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2023
CompletedMay 24, 2022
May 1, 2022
9 months
May 10, 2022
May 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
postoperative NRS score
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.
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 (11)
Dosage of remedial analgesics postoperatively
It takes about 24 hours.
Hemodynamic fluctuation
From the beginning of the general anesthesia induction to the time leaving PACU, it takes about 4 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.
recovery time
It will take up to 1 hour or 2 hours.
The levels of C-reactive protein (CRP)
It takes about 24 hours.
- +6 more secondary outcomes
Study Arms (2)
Opioid anesthesia group
OTHERAnesthesia 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.
Opioid free anesthesia group
EXPERIMENTALAnesthesia 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.
Interventions
We have adopted a variety of methods to replace the use of opioids in the process of balanced anesthesia.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yongtao Sun
Jinan, Shandong, 250000, China
Related Publications (1)
Guo Y, Chen L, Gao Z, Zhang M, Liu M, Gao X, Liu Y, Zhang X, Guo N, Sun Y, Wang Y. Is esketamine-based opioid-free anesthesia more superior for postoperative analgesia in obstructive sleep apnea patients undergoing bariatric surgery? A study protocol. Front Med (Lausanne). 2022 Nov 15;9:1039042. doi: 10.3389/fmed.2022.1039042. eCollection 2022.
PMID: 36457567DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Yongtao Sun, doctor
Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 10, 2022
First Posted
May 24, 2022
Study Start
May 15, 2022
Primary Completion
January 31, 2023
Study Completion
October 31, 2023
Last Updated
May 24, 2022
Record last verified: 2022-05