Postoperative Nausea and VomitingPhase 2/3NCT05516953
Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery
A Phase 2/3 study testing Baclofen Tablets in people with Postoperative Nausea and Vomiting and Laparoscopic Sleeve Gastrectomy, run by Tanta University at 1 site in Egypt.
Trial summary
This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, Morbid Obesity
- What is being tested?
- Baclofen Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Aug 2022to 28 Feb 2025
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
- Patients fit for anesthesia and surgery.
Who cannot join
- Patients with BMI >55 kg/m2.
- Patients with previous procedures for the treatment of obesity.
- Pregnant females and lactating women.
- Patients with psychological or psychiatric disease
- Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
- Patients who experienced vomiting within 24 hours before surgery.
- Patients with history of alcohol or drug abuse.
- Patients with hypersensitivity or contraindications to any of the drugs used in this study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital.
Tanta, 31111
About this study
Official title: Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
Read the detailed description
. A total of 100 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into four groups by closed envelop method
- Being tested
- Baclofen Tablets
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, baclofen, Morbid Obesity
- Medical subject headings
- Postoperative Nausea and Vomiting, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baclofen TabletsDrug
Also called baclofen
10 mg oral baclofen 1 h before anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group 1(Control group) | No intervention | include 50 patients scheduled for sleeve gastrectomy |
| Group 2 | Experimental | which include 50 patients scheduled for sleeve gastrectomy Receives: Drug: Baclofen Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome of this study will be the complete response
Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy.
Measured: The first 48 hours after surgery.
Secondary outcomes (5)
Change in serum level of vasopressin
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Measured: The first 48 hours after surgery.
Change in serum level of substance P
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Measured: The first 48 hours after surgery.
Change in serum level of dopamine
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Measured: The first 48 hours after surgery.
Change in serum level of serotonin
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Measured: The first 48 hours after surgery.
Change in serum level of tachykinin 1
Blood samples will be collected at baseline, 24 hours and 48 hours after surgery
Measured: The first 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 posted26 Aug 2022
- Study start22 Aug 2022
- Primary completion28 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Tanta 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Moussa, Tanta University
- Investigators
- Aya Moussa, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516953
- Sponsor's protocol ID
- 35647/8/22
- Status last verified
- Apr 2025
- First submitted
- 24 Aug 2022
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moussa AG, El-Haggar SM, El-Mahdy TM, Mostafa TM. Efficacy and safety of baclofen in the prophylaxis of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized controlled trial. BMC Surg. 2026 Apr 15;26(1):271. doi: 10.1186/s12893-026-03696-4.
PubMed 41981586
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05516953
- Acronym / sponsor ID
- 35647/8/22
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, baclofen, Morbid Obesity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 28 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 26 Aug 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 aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
Detailed description
. A total of 100 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into four groups by closed envelop method
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1(Control group) | No intervention | –include 50 patients scheduled for sleeve gastrectomy |
| Group 2 | Experimental | Drug: Baclofen Tabletswhich include 50 patients scheduled for sleeve gastrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
- Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
- Patients fit for anesthesia and surgery.
Key exclusion criteria (8 listed)
- Patients with BMI >55 kg/m2.
- Patients with previous procedures for the treatment of obesity.
- Pregnant females and lactating women.
- Patients with psychological or psychiatric disease
- Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
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 |
|---|---|---|
| Baclofen TabletsAlso: baclofen10 mg oral baclofen 1 h before anesthesia | Drug | Group 2 |
Primary outcome
The primary outcome of this study will be the complete response
Time frame: The first 48 hours after surgery.
Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy.
5 secondary outcomes
Change in serum level of vasopressin
Time frame: The first 48 hours after surgery.
Change in serum level of substance P
Time frame: The first 48 hours after surgery.
Change in serum level of dopamine
Time frame: The first 48 hours after surgery.
Change in serum level of serotonin
Time frame: The first 48 hours after surgery.
Change in serum level of tachykinin 1
Time frame: The first 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 22 Apr 2025.
- Derived from this study: PubMed 41981586Moussa AG, El-Haggar SM, El-Mahdy TM, Mostafa TM. Efficacy and safety of baclofen in the prophylaxis of postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized controlled trial. BMC Surg. 2026 Apr 15;26(1):271. doi: 10.1186/s12893-026-03696-4.
- Individual participant dataSharing planned: No
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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.
Aya Moussa principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baclofen Tablets in people with Postoperative Nausea and Vomiting and Laparoscopic Sleeve Gastrectomy, run by Tanta University at 1 site in Egypt.
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 3 inclusion and 8 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 22 Apr 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 Egypt. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome of this study will be the complete response (time frame: The first 48 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 NCT05516953, which also lists 1 linked publication.
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 22 Apr 2025.