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

The Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery: a Single-center Randomized Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Diseases; Postoperative Nausea and Vomiting; Opioid Use
• Intervention / Treatment: Procedure: Opioid-Free Anesthesia (OFA); Procedure: Standard general anesthesia (OA)

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 Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing ChaoYang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Opioid-Free Anesthesia (OFA froup); Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs.	Procedure: Opioid-Free Anesthesia (OFA); Opioid-free general anesthesia protocol: After entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.), dexmedetomidine (0.5ug/kg i.v. in 15min), and ultrasound-guided T4-5 paravertebral nerve block (0.5% Ropivacaine 20ml). Induction of anesthesia with lidocaine (1.5mg/kg i.v.), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v.). Intraoperative anesthesia was maintained by desflurane (0.5-1MAC), continuous intravenous infusion of dexmedetomidine (0.5ug/kg/h), and lidocaine (1.5mg/kg/h). Flurbiprofen (50 mg i.v.) given at the time of skin suture.; Other Names: Non-Opioid anesthesia (NOA)
Active Comparator: Standard general anesthesia (OA); Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs.	Procedure: Standard general anesthesia (OA); Standard general anesthesia protocol: After entering the operating room, patients were given dexamethasone (5mg i.v.), atropine (0.25mg i.v.), flurbiprofen (50mg i.v.). Induction of anesthesia with lidocaine (1.5mg/kg i.v.), sufentanil (0.3-0.4ug/kg), propofol (2-3mg/kg, i.v.), rocuronium (6-8mg i.v. ). Intraoperative anesthesia was maintained by desflurane (0.5-1MAC) and continuous intravenous infusion of remifentanil (0.1-0.2ug/kg/min). Flurbiprofen (50 mg i.v.) given at the time of skin suture.; Other Names: Opioid-based general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting	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.	24 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The score of Simplified postoperative nausea and vomiting impact scale	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)	24 hours after surgery
Quality of post-operative recovery	Assessed by the of quality of recovery-15 (QoR-15) scale. (0-150 points, High scores represent better)	24 hours after surgery
Postoperative pain at rest and cough	Assessed by the Numerical Assessment Scale (NRS) for pain. (0-10 points, High scores represent worse)	24 hours after surgery
The six minute walking test (6MWT)	Assessed by the 6MWT worksheet and report. (High scores represent better)	48 hours after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative length of hospital stay	Length of hospital stay in days	Up to 7 days after surgery
Postoperative anesthesia care unit (PACU) duration	PACU duration in minutes	Up to 4 hours after surgery
Intraoperative complications	Assessed according to ClassIntra complication classifications	From entering to leaving the operating room, an average of 4 hours
Postoperative Complications	Assessed according to Clavien-Dindo surgical complication classifications	within 7 days after surgery or discharge
Health and well-being after surgery	Assessed according to the Short-Form (SF-36) health survey, included 36 items groups in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.	6 month after surgery

Collaborators and Investigators

• Sponsor: Beijing Chao Yang Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Dell-Kuster S, Gomes NV, Gawria L, Aghlmandi S, Aduse-Poku M, Bissett I, Blanc C, Brandt C, Ten Broek RB, Bruppacher HR, Clancy C, Delrio P, Espin E, Galanos-Demiris K, Gecim IE, Ghaffari S, Gie O, Goebel B, Hahnloser D, Herbst F, Ioannidis O, Joller S, Kang S, Martin R, Mayr J, Meier S, Murugesan J, Nally D, Ozcelik M, Pace U, Passeri M, Rabanser S, Ranter B, Rega D, Ridgway PF, Rosman C, Schmid R, Schumacher P, Solis-Pena A, Villarino L, Vrochides D, Engel A, O'Grady G, Loveday B, Steiner LA, Van Goor H, Bucher HC, Clavien PA, Kirchhoff P, Rosenthal R. Prospective validation of classification of intraoperative adverse events (ClassIntra): international, multicentre cohort study. BMJ. 2020 Aug 25;370:m2917. doi: 10.1136/bmj.m2917. Erratum In: BMJ. 2025 Jan 22;388:r117. doi: 10.1136/bmj.r117.

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: June 5, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 15, 2025
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Signs and Symptoms, Digestive; Respiratory Tract Diseases; Nausea; Vomiting; Postoperative Nausea and Vomiting; Thoracic Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid; Anesthetics
• Other Study ID Numbers: 2022020817

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The extent to which data is shared will be determined based on the progress of the study and local healthcare policies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No