Postoperative Nausea and Vomiting (PONV)Phase 1NCT07201883
Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients
A Phase 1 study testing Ondansetron (Zofran), chewing gum and Ondansetron + Chewing gum in people with Postoperative Nausea and Vomiting (PONV), run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
The proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV)
- What is being tested?
- Ondansetron (Zofran), chewing gum and Ondansetron + Chewing gum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteLebanon
- Study dates
- 22 Aug 2025to 28 Feb 2026
- Phase
- Phase 1
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females
- Aged 18 and above,
- Weight 40kg and above,
- Who have undergone laparoscopic
- Surgery under volatile anesthetic-based general anesthesia.
Who cannot join
- Have history of motion sickness,
- Maintained anesthesia during surgery using Propofol-pump
- Were given antiemetics within 8 hours pre-surgery
- Allergy to ondansetron
- Planned mechanical ventilation post-operation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial; Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients Undergoing Laparoscopic Surgery at a Single Centre in Lebanon
The proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU).
Read the detailed description
Post-operative nausea and vomiting remains a significant complication following general anesthesia, particularly when volatile anesthetics are used. Previous studies, including a multicenter randomized trial conducted in Australia, have explored alternative treatment modalities for PONV. Chewing gum, a non-pharmacological intervention, has shown promise as a potential alternative or adjunct to conventional antiemetics like ondansetron. This study focuses on the Lebanese female population, aged 18 and above, who have undergone laparoscopic surgery under volatile anesthetic-based general anesthesia. This demographic is chosen based on established risk factors for PONV and may offer unique insights into efficacy within this subgroup.
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Being tested
- Ondansetron (Zofran), chewing gum, Ondansetron + Chewing gum
- Keywords
- PONV, Ondansetron, Postoperative Period, Vomiting, Laparoscopy, Antiemetics
- Medical subject headings
- Postoperative Nausea and Vomiting, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ondansetron (Zofran)Drug
4 mg IV push
chewing gumOther
Peppermint sugar free chewing gum
Ondansetron + Chewing gumCombination product
Ondansetron 4 mg IV push Peppermint sugar free chewing gum
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Active comparator | Not described Receives: Drug: Ondansetron (Zofran) |
| Chewing Gum | Experimental | Not described Receives: Other: chewing gum |
| Ondansetron + Chewing Gum | Sham comparator | Not described Receives: Combination Product: Ondansetron + Chewing gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cessation of PONV with no recurrence and no rescue medication
Measured: 2 hours
Secondary outcomes (2)
Patient satisfaction
Measured: post-operative period ( up to 3 hours)
Quantity of rescue treatment modalities used
Measured: immediately after PONV start until complete resolution of symptoms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start22 Aug 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
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 Vomiting (PONV)Studies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Rajab, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201883
- Sponsor's protocol ID
- MGH-07-25038
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
PubMed 2286697
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial; Chewing Gum vs. Ondansetron as Rescue Treatment for PONV in Female Patients Undergoing Laparoscopic Surgery at a Single Centre in Lebanon
- ClinicalTrials.gov ID
- NCT07201883
- Acronym / sponsor ID
- MGH-07-25038
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- PONV, Ondansetron, Postoperative Period, Vomiting, Laparoscopy, Antiemetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 1 Oct 2025 (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 proposed randomized clinical trial aims to test and compare the efficacy of chewing gum vs. Intravenous antiemetic ondansetron as rescue treatment for post-operative nausea and vomiting (PONV) among Lebanese female patients undergoing laparoscopic surgery in the post-operative anesthesia care unit (PACU).
Detailed description
Post-operative nausea and vomiting remains a significant complication following general anesthesia, particularly when volatile anesthetics are used. Previous studies, including a multicenter randomized trial conducted in Australia, have explored alternative treatment modalities for PONV. Chewing gum, a non-pharmacological intervention, has shown promise as a potential alternative or adjunct to conventional antiemetics like ondansetron. This study focuses on the Lebanese female population, aged 18 and above, who have undergone laparoscopic surgery under volatile anesthetic-based general anesthesia. This demographic is chosen based on established risk factors for PONV and may offer unique insights into efficacy within this subgroup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Active comparator | Drug: Ondansetron (Zofran) |
| Chewing Gum | Experimental | Other: chewing gum |
| Ondansetron + Chewing Gum | Sham comparator | Combination Product: Ondansetron + Chewing gum |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Females
- Aged 18 and above,
- Weight 40kg and above,
- Who have undergone laparoscopic
- Surgery under volatile anesthetic-based general anesthesia.
Key exclusion criteria (5 listed)
- Have history of motion sickness,
- Maintained anesthesia during surgery using Propofol-pump
- Were given antiemetics within 8 hours pre-surgery
- Allergy to ondansetron
- Planned mechanical ventilation post-operation
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 (Zofran)4 mg IV push | Drug | Ondansetron |
| chewing gumPeppermint sugar free chewing gum | Other | Chewing Gum |
| Ondansetron + Chewing gumOndansetron 4 mg IV push Peppermint sugar free chewing gum | Combination product | Ondansetron + Chewing Gum |
Primary outcome
Complete cessation of PONV with no recurrence and no rescue medication
Time frame: 2 hours
2 secondary outcomes
Patient satisfaction
Time frame: post-operative period ( up to 3 hours)
Quantity of rescue treatment modalities used
Time frame: immediately after PONV start until complete resolution of symptoms
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 1 Oct 2025.
- Results publication: PubMed 2286697Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51.
- Related InfoLink provided by the sponsor.
- 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 1 study testing Ondansetron (Zofran), chewing gum and Ondansetron + Chewing gum in people with Postoperative Nausea and Vomiting (PONV), run by Makassed General Hospital at 1 site in Lebanon.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 1 Oct 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 Lebanon. 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. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Complete cessation of PONV with no recurrence and no rescue medication (time frame: 2 hours). 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 NCT07201883, 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 1 Oct 2025.