PONVNCT07806162
Comparison Between Opioid-Free Anaesthesia Versus Opioid Based Anesthesia in Reduction Postoperative Nausea and Vomiting (PONV)After Thoracoscopic Lung Resection.
A study testing Opioid Free Anaesthesia and conventential opioid-based anaesthesia (OBA, in people with PONV, run by Sohag University.
Trial summary
The invistigators hypothesized that a protocolized OFA technique would lower the occurance of PONV in patients undergoing thoracoscopic lung surgery compared to standard opioid-based anaesthesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- PONV
- What is being tested?
- Opioid Free Anaesthesia and conventential opioid-based anaesthesia (OBA,
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants were adults (18-80 years).
- Prepared for elective thoracoscopic lobectomy or segmentectomy for lung cancer under general anaesthesia
Who cannot join
- Contraindication to any study drug (e.g., heart block, severe liver disease, allergy).
- Chronic opioid use (>30 MME/day for >3 months).
- Patients with renal impairment (e GFR <30 mL/min).
- Pregnancy.
- Inability to comprehend pain scales.
About this study
Official title: Comparison Between Opioid-Free Anaesthesia Versus Opioid Based Anesthesia in Reduction Postoperative Nausea and Vomiting (PONV)After Thoracoscopic Lung Resection. A Prospective Randomised Controlled Trial)
The invistigators hypothesized that a protocolized OFA technique would lower the occurance of PONV in patients undergoing thoracoscopic lung surgery compared to standard opioid-based anaesthesia.
- Conditions
- PONV
- Being tested
- Opioid Free Anaesthesia, conventential opioid-based anaesthesia (OBA,
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid Free AnaesthesiaDrug
The OFA group protocol consists of a combination of intravenous lidocaine, ketamine, dexmedetomidine, and propofol TIVA.
conventential opioid-based anaesthesia (OBA,Drug
The OBA group protocol consists of balanced anaesthesia with fentanyl plus sevoflurane.
| Study group | Role | What they receive |
|---|---|---|
| conventential opioid-based anaesthesia (OBA, n=60). | Placebo comparator | Not described Receives: Drug: conventential opioid-based anaesthesia (OBA, |
| opioid free anesthesia( OFA , n=60) | Experimental | Not described Receives: Drug: Opioid Free Anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the occurrence of PONV during the initial 24 hours
Measured: 24 hours
Secondary outcomes (3)
total opioid consumption over 24 hour (expressed as morphine milligram equivalents.
Measured: 24 hours
pain intensity scores (numerical rating scale NRS 0-10)
Measured: 24 hours
recovery quality (QoR-15 score)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion20 Oct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Islam Mokhtar Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806162
- Sponsor's protocol ID
- Soh-Med-26-6-14PD
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Opioid-Free Anaesthesia Versus Opioid Based Anesthesia in Reduction Postoperative Nausea and Vomiting (PONV)After Thoracoscopic Lung Resection. A Prospective Randomised Controlled Trial)
- ClinicalTrials.gov ID
- NCT07806162
- Acronym / sponsor ID
- Soh-Med-26-6-14PD
- Conditions
- PONV
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 20 Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 8 Sep 2026 (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.
The invistigators hypothesized that a protocolized OFA technique would lower the occurance of PONV in patients undergoing thoracoscopic lung surgery compared to standard opioid-based anaesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventential opioid-based anaesthesia (OBA, n=60). | Placebo comparator | Drug: conventential opioid-based anaesthesia (OBA, |
| opioid free anesthesia( OFA , n=60) | Experimental | Drug: Opioid Free Anaesthesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Eligible participants were adults (18-80 years).
- Prepared for elective thoracoscopic lobectomy or segmentectomy for lung cancer under general anaesthesia
Key exclusion criteria (5 listed)
- Contraindication to any study drug (e.g., heart block, severe liver disease, allergy).
- Chronic opioid use (>30 MME/day for >3 months).
- Patients with renal impairment (e GFR <30 mL/min).
- Pregnancy.
- Inability to comprehend pain scales.
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 AnaesthesiaThe OFA group protocol consists of a combination of intravenous lidocaine, ketamine, dexmedetomidine, and propofol TIVA. | Drug | opioid free anesthesia( OFA , n=60) |
| conventential opioid-based anaesthesia (OBA,The OBA group protocol consists of balanced anaesthesia with fentanyl plus sevoflurane. | Drug | conventential opioid-based anaesthesia (OBA, n=60). |
Primary outcome
the occurrence of PONV during the initial 24 hours
Time frame: 24 hours
3 secondary outcomes
total opioid consumption over 24 hour (expressed as morphine milligram equivalents.
Time frame: 24 hours
pain intensity scores (numerical rating scale NRS 0-10)
Time frame: 24 hours
recovery quality (QoR-15 score)
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for PONV
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid Free Anaesthesia and conventential opioid-based anaesthesia (OBA, in people with PONV, run by Sohag University.
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 2 inclusion and 5 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: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
the occurrence of PONV during the initial 24 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Sep 2026.