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

NCT05411159 | Completed DMC

• 1 other identifier: 2022020817
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Nausea and Vomiting; Opioid Use; Thoracic Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The score of Simplified postoperative nausea and vomiting impact scale

  24 hours after surgery

• Quality of post-operative recovery

  24 hours after surgery

• Postoperative pain at rest and cough

  24 hours after surgery

• The six minute walking test (6MWT)

  48 hours after surgery

Other Outcomes (5)

• Postoperative length of hospital stay

  Up to 7 days after surgery

• Postoperative anesthesia care unit (PACU) duration

  Up to 4 hours after surgery

• Intraoperative complications

  From entering to leaving the operating room, an average of 4 hours

Study Arms (2)

Opioid-Free Anesthesia (OFA froup)

EXPERIMENTAL

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

Procedure: Opioid-Free Anesthesia (OFA)

Standard general anesthesia (OA)

ACTIVE COMPARATOR

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

Procedure: Standard general anesthesia (OA)

Interventions

Opioid-Free Anesthesia (OFA) PROCEDURE

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.

Also known as: Non-Opioid anesthesia (NOA)

Opioid-Free Anesthesia (OFA froup)

Standard general anesthesia (OA) PROCEDURE

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.

Also known as: Opioid-based general anesthesia

Standard general anesthesia (OA)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Chao Yang Hospital: lead

Study Sites (1)

Beijing Chaoyang Hospital

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (6)

• 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.

  PMID: 22290456 BACKGROUND

• 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.

  PMID: 29397134 BACKGROUND

• 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.

  PMID: 32843333 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

• Yan X, Liang C, Jiang J, Ji Y, Wu AS, Wei CW. Effects of balanced opioid-free anesthesia on post-operative nausea and vomiting in patients undergoing video-assisted thoracic surgery: a randomized trial. BMC Anesthesiol. 2025 Feb 8;25(1):62. doi: 10.1186/s12871-025-02938-x.

  PMID: 39923016 DERIVED

• Yan X, Liang C, Jiang J, Ji Y, Wu A, Wei C. Effects of opioid-free anaesthesia on postoperative nausea and vomiting in patients undergoing video-assisted thoracoscopic surgery (OFA-PONV trial): study protocol for a randomised controlled trial. Trials. 2023 Dec 20;24(1):819. doi: 10.1186/s13063-023-07859-z.

  PMID: 38124084 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting; Thoracic Diseases

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of department of Anesthesiology

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 9, 2022
• Study Start: June 7, 2022
• Primary Completion: April 30, 2024
• Study Completion: November 30, 2024
• Last Updated: March 19, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)