Post Operative Nausea and VomitingPhase 3NCT05620641
Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
A Phase 3 study testing Ondansetron 8mg and Gabapentin in people with Post Operative Nausea and Vomiting and Sleeve Gastrectomy, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the possible efficacy of ondansetron and gabapentin 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
- Post Operative Nausea and Vomiting, Sleeve Gastrectomy, Morbid Obesity
- What is being tested?
- Ondansetron 8mg and Gabapentin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Apr 2025
- Phase
- Phase 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
- Both male and female patients will be included.
- 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, Egypt
Tanta, Gharbia Governorate, 31111
About this study
Official title: Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
Read the detailed description
This study will be a double blind randomized, controlled, parallel, study. A total of1 00 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 two groups by closed envelop method,
- Being tested
- Ondansetron 8mg, Gabapentin
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, ondansetron, gabapentine
- Medical subject headings
- Vomiting, Obesity, Morbid, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron 8mgDrug
Also called zofran
50 patients will receive intravenous ondansetron 8 mg before the end of surgery.
GabapentinDrug
50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | include 50 patients scheduled for sleeve gastrectomy Receives: Drug: Ondansetron 8mg |
| Group 2 | Experimental | include 50 patients scheduled for sleeve gastrectomy Receives: Drug: Gabapentin |
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 within the first 48 h after surgery.
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 the level of the biological parameter vasopressin
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of vasopressin
Measured: The first 48 hours after surgery.
change in the level of the biological parameter dopamine
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of dopamine
Measured: The first 48 hours after surgery.
change in the level of the biological parameter substance p
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of substance p
Measured: The first 48 hours after surgery.
change in the level of the biological parameter Serotonin
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Serotonin
Measured: The first 48 hours after surgery.
change in the level of the biological parameter Tachykinin 1
5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Tachykinin 1
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 posted17 Nov 2022
- Study start1 Oct 2022
- Primary completion28 Feb 2025
- Study completion1 Apr 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 Post Operative 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 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620641
- Sponsor's protocol ID
- 35647
- Status last verified
- Apr 2025
- First submitted
- 11 Nov 2022
- Last updated
- 17 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. Ondansetron versus gabapentin in preventing postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized study. Naunyn Schmiedebergs Arch Pharmacol. 2026 Aug 25. doi: 10.1007/s00210-026-05825-5. Online ahead of print.
PubMed 42637866
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05620641
- Acronym / sponsor ID
- 35647
- Keywords
- Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, ondansetron, gabapentine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 17 Nov 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.
The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.
Detailed description
This study will be a double blind randomized, controlled, parallel, study. A total of1 00 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 two 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 | Experimental | Drug: Ondansetron 8mginclude 50 patients scheduled for sleeve gastrectomy |
| Group 2 | Experimental | Drug: Gabapentininclude 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 (4 listed)
- Both male and female patients will be included.
- 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 |
|---|---|---|
| Ondansetron 8mgAlso: zofran50 patients will receive intravenous ondansetron 8 mg before the end of surgery. | Drug | Group 1 |
| Gabapentin50 patients will receive 600 mg oral gabapentin 1 h before anesthesia. | Drug | Group 2 |
Primary outcome
The primary outcome of this study will be the complete response within the first 48 h after surgery.
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 the level of the biological parameter vasopressin
Time frame: The first 48 hours after surgery.
change in the level of the biological parameter dopamine
Time frame: The first 48 hours after surgery.
change in the level of the biological parameter substance p
Time frame: The first 48 hours after surgery.
change in the level of the biological parameter Serotonin
Time frame: The first 48 hours after surgery.
change in the level of the biological parameter 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 17 Apr 2025.
- Derived from this study: PubMed 42637866Moussa AG, El-Haggar SM, El-Mahdy TM, Mostafa TM. Ondansetron versus gabapentin in preventing postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized study. Naunyn Schmiedebergs Arch Pharmacol. 2026 Aug 25. doi: 10.1007/s00210-026-05825-5. Online ahead of print.
- 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.
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 Phase 3 study testing Ondansetron 8mg and Gabapentin in people with Post Operative Nausea and Vomiting and 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 4 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 17 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 phase mean?
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 within the first 48 h after surgery. (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 NCT05620641, 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 17 Apr 2025.