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

Capital Medical University

Status: Completed

Conditions: Postoperative Nausea and Vomiting; Thoracic Diseases; Opioid Use

Treatments: Procedure: Opioid-Free Anesthesia (OFA); Procedure: Standard general anesthesia (OA)

Study type: Interventional

Funder types: Other

Identifiers

NCT05411159

2022020817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

Opioid-Free Anesthesia (OFA froup)

Experimental group

Description:

Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs.

Treatment:

Procedure: Opioid-Free Anesthesia (OFA)

Standard general anesthesia (OA)

Active Comparator group

Description:

Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs.

Treatment:

Procedure: Standard general anesthesia (OA)