Postoperative Nausea and VomitingOFA-PONVNCT05411159
Effect of Opioid-free Anesthesia on PostOperative Nausea and Vomiting in Patients Undergoing Video-assisted Thoracoscopic Surgery
A study testing Opioid-Free Anesthesia (OFA) and Standard general anesthesia (OA) in people with Postoperative Nausea and Vomiting and Opioid Use, run by Beijing Chao Yang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Opioid Use, Thoracic Diseases
- What is being tested?
- Opioid-Free Anesthesia (OFA) and Standard general anesthesia (OA)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Opioid-Free Anesthesia (OFA), Standard general anesthesia (OA)
- Medical subject headings
- Postoperative Nausea and Vomiting, Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-Free Anesthesia (OFA)Procedure or surgery
Also called Non-Opioid anesthesia (NOA)
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.
Standard general anesthesia (OA)Procedure or surgery
Also called Opioid-based general anesthesia
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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid-Free Anesthesia (OFA froup) | Experimental | Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs. Receives: Procedure: Opioid-Free Anesthesia (OFA) |
| Standard general anesthesia (OA) | Active comparator | Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs. Receives: Procedure: Standard general anesthesia (OA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 24 hours after surgery
The six minute walking test (6MWT)
Assessed by the 6MWT worksheet and report. (High scores represent better)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start7 Jun 2022
- Primary completion30 Apr 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anshi Wu, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411159
- Sponsor's protocol ID
- 2022020817
- Acronym
- OFA-PONV
- Status last verified
- Apr 2024
- First submitted
- 30 May 2022
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The extent to which data is shared will be determined based on the progress of the study and local healthcare policies
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.
PubMed 22290456Kleif 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.
PubMed 29397134Dell-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.
PubMed 32843333Dindo 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.
PubMed 15273542Yan X, Liang C, Guo M, Jiang J, Ji Y, Wu AS, Wei CW. Effect of EEG-guided opioid-free anesthesia on perioperative blood glucose variation in patients undergoing video-assisted thoracic surgery: a secondary analysis of a randomized controlled study. Perioper Med (Lond). 2026 Mar 3;15(1):36. doi: 10.1186/s13741-026-00666-5.
PubMed 41776687Yan 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.
PubMed 39923016Yan 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.
PubMed 38124084
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05411159
- Acronym / sponsor ID
- OFA-PONV / 2022020817
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid-Free Anesthesia (OFA froup) | Experimental | Procedure: Opioid-Free Anesthesia (OFA)Opioid-free anesthesia group, avoid patients receive any kind of opioid during VATs. |
| Standard general anesthesia (OA) | Active comparator | Procedure: Standard general anesthesia (OA)Standard general anesthesia. Opioids allowed, including sufentanil, remifentanil, tramadol during VATs. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inpatients planning elective thoracoscopic lobectomy or wedge resection under general anesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid-Free Anesthesia (OFA)Also: Non-Opioid anesthesia (NOA)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. | Procedure or surgery | Opioid-Free Anesthesia (OFA froup) |
| Standard general anesthesia (OA)Also: Opioid-based general anesthesiaStandard 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. | Procedure or surgery | Standard general anesthesia (OA) |
Primary outcome
Incidence of postoperative nausea and vomiting
Time frame: 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.
4 secondary outcomes
The score of Simplified postoperative nausea and vomiting impact scale
Time frame: 24 hours after surgery
Quality of post-operative recovery
Time frame: 24 hours after surgery
Postoperative pain at rest and cough
Time frame: 24 hours after surgery
The six minute walking test (6MWT)
Time frame: 48 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Results publication: PubMed 22290456Myles 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.
- Results publication: PubMed 29397134Kleif 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.
- Results publication: PubMed 32843333Dell-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.
- Results publication: PubMed 15273542Dindo 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.
- Derived from this study: PubMed 41776687Yan X, Liang C, Guo M, Jiang J, Ji Y, Wu AS, Wei CW. Effect of EEG-guided opioid-free anesthesia on perioperative blood glucose variation in patients undergoing video-assisted thoracic surgery: a secondary analysis of a randomized controlled study. Perioper Med (Lond). 2026 Mar 3;15(1):36. doi: 10.1186/s13741-026-00666-5.
- Derived from this study: PubMed 39923016Yan 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.
- Derived from this study: PubMed 38124084Yan 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.
- Individual participant dataSharing planned: No. The extent to which data is shared will be determined based on the progress of the study and local healthcare policies
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid-Free Anesthesia (OFA) and Standard general anesthesia (OA) in people with Postoperative Nausea and Vomiting and Opioid Use, run by Beijing Chao Yang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative nausea and vomiting (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05411159, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.