Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery

Not Applicable

Completed

• Conditions: Opioid Use; Postoperative Nausea and Vomiting; Thoracic Diseases
• Interventions: Procedure: Opioid-Free Anesthesia (OFA); Procedure: Standard general anesthesia (OA)

• Registration Number: NCT05411159
• Lead Sponsor: Beijing Chao Yang Hospital

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.

Study Timeline

• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-06-05
• Study Start: 2022-06-07
• Study First Posted: 2022-06-09
• Status Verified: 2024-04
• Primary Completion: 2024-04-30
• Study Completion: 2024-11-30
• Last Update Submitted: 2025-03-15
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid-Free Anesthesia (OFA froup)	Opioid-Free Anesthesia (OFA)	Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs.
Standard general anesthesia (OA)	Standard general anesthesia (OA)	Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs.

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative nausea and vomiting	24 hours after surgery	Assessed using Myles's simplified postoperative nausea and vomiting impact scale.; The scale on the scale is a composite of the following 2 parts: (1) vomited or had dry-retching (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe).; The score\>0 is regarded as PONV occurred.

Secondary Outcome Measures

Name	Time	Method
Quality of post-operative recovery	24 hours after surgery	Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better)
The score of Simplified postoperative nausea and vomiting impact scale	24 hours after surgery	Assessed using Myles's simplified postoperative nausea and vomiting impact scale.; The score on the scale is a composite of the following 2 parts: (1) vomited or had dry-retching score (0-3 points), and (2) nausea ( 0-3 points). (High scores represent severe)
Postoperative pain at rest and cough	24 hours after surgery	Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse)
The six minute walking test (6MWT)	48 hours after surgery	Assessed by the 6MWT worksheet and report. (High scores represent better)

Trial Locations

Locations (1)

Beijing Chaoyang Hospital; 🇨🇳 Beijing, Beijing, China