Clinical trial NCT05411159: Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery
Official title: The Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery: a Single-center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Opioid Use
Thoracic Diseases
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aimed to verify whether an Opioid-free Anesthesia (OFA) could effectively reduce the incidence of PONV after thoracoscopic-assisted surgery compared with standard general anesthesia (OA) regimens.

Detailed description: Postoperative Nausea and Vomiting (PONV) is one of the most common complications after general anesthesia, which significantly reduces postoperative comfort and satisfaction of patients perioperatively. Meta-analysis showed that Opioid-free Anesthesia (OFA) significantly reduced the risk of postoperative PONV events in patients undergoing gynecology, breast, and abdominal surgery compared with standard general anesthesia (OA). The main hypothesis of the study is that an OFA could reduce the incidence of PONV in patients after thoracoscopic-assisted surgery than OA.

Eligibility criteria: Inclusion Criteria:

* Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia

Exclusion Criteria:

* ASA classification \> 4
* BMI\>35kg/m2
* Unable to communicate before surgery
* Received radiation therapy, chemotherapy, opioids or hormonal drugs within 14 days before surgery
* Anticipated intolerance to the anesthesia protocol of this study
* Expect prolonged mechanical ventilation after surgery
* Decline

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: The score of Simplified postoperative nausea and vomiting impact scale
timeFrame: 24 hours after surgery
measure: Quality of post-operative recovery
timeFrame: 24 hours after surgery
measure: Postoperative pain at rest and cough
timeFrame: 24 hours after surgery
measure: The six minute walking test (6MWT)
timeFrame: 48 hours after surgery
Other outcomes:
measure: Postoperative length of hospital stay
timeFrame: Up to 7 days after surgery
measure: Postoperative anesthesia care unit (PACU) duration
timeFrame: Up to 4 hours after surgery
measure: Intraoperative complications
timeFrame: From entering to leaving the operating room, an average of 4 hours
measure: Postoperative Complications
timeFrame: within 7 days after surgery or discharge
measure: Health and well-being after surgery
timeFrame: 6 month after surgery
Locations:
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
Study officials:
References:
citation: Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29.
citation: Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth. 2018 Jan;120(1):28-36. doi: 10.1016/j.bja.2017.11.013. Epub 2017 Nov 22.
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citation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.