Postoperative Nausea and Vomiting (PONV)Phase 4NCT06886230
Ondansetron vs. Dexamethasone for Postoperative Nausea
A Phase 4 study testing Ondansetron (Zofran) and Dexamethasone in people with Postoperative Nausea and Vomiting (PONV), run by Hafiz Muhammad Hamza at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to evaluate the safety and efficacy of Ondansetron, Dexamethasone, and their combination in managing postoperative nausea and vomiting (PONV) in patients undergoing surgery under anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV)
- What is being tested?
- Ondansetron (Zofran) and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 11 Jun 2025
- Phase
- Phase 4
- 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
- Adult patients (≥18 years) scheduled for elective surgery under anesthesia.
- Patients at moderate to high risk for postoperative nausea and vomiting (PONV), as determined by an Apfel risk score ≥2.
- Patients able to provide informed consent or have a legally authorized representative provide consent.
Who cannot join
- Known allergy or hypersensitivity to Ondansetron, Dexamethasone, or any of their components.
- History of significant adverse reactions to previous PONV prophylaxis with Ondansetron or Dexamethasone.
- Pre-existing conditions or medications contraindicating the use of Ondansetron or Dexamethasone, e.g. QT prolongation or severe cardiac arrhythmias (e.g., torsades de pointes, congenital long QT syndrome), Uncontrolled hypertension (for Dexamethasone use), Severe hepatic impairment (Child-Pugh C) or end-stage renal disease, Uncontrolled diabetes mellitus (due to Dexamethasone-induced hyperglycemia).
- Patients with active malignancy undergoing chemotherapy or radiotherapy.
- Pregnant or lactating women (unless safety in this population is specifically being studied).
- Chronic opioid users (≥3 months of continuous opioid use), as this may alter PONV risk and response to prophylaxis.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Federal Government Polyclinic (Postgraduate Medical Institute)
Islamabad, Capital, 051
About this study
Official title: Assessing The Safety and Efficacy of Ondansetron, Dexamethasone, and Their Combined Regimen in Managing Post Operative Nausea and Vomiting: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the safety and efficacy of Ondansetron, Dexamethasone, and their combination in managing postoperative nausea and vomiting (PONV) in patients undergoing surgery under anesthesia. A total of 100 patients will be randomized into four groups: Placebo, Ondansetron, Dexamethasone, and Ondansetron-Dexamethasone combination. The primary outcome will be the incidence of PONV within 24 hours post-surgery, while secondary outcomes include severity of symptoms, need for rescue medication, adverse effects, and patient satisfaction.
Read the detailed description
Postoperative nausea and vomiting (PONV) is a common and distressing complication following surgery, affecting patient recovery and satisfaction. This study aims to compare the safety and effectiveness of Ondansetron, Dexamethasone, and their combination for PONV prevention.
The study will be conducted as a randomized, controlled trial at Federal Polyclinic Hospital Islamabad over four months. A total of 100 adult patients undergoing elective surgery under anesthesia will be enrolled and randomly allocated into one of four groups (n=25 each):
Placebo group - Receives no prophylactic antiemetic treatment. Ondansetron group - Receives 4 mg IV Ondansetron before surgery. Dexamethasone group - Receives 8 mg IV Dexamethasone before surgery. Ondansetron-Dexamethasone group - Receives 4 mg IV Ondansetron + 8 mg IV Dexamethasone before surgery.
Methodology:
Patients will be assessed at multiple time points (2, 4, 6, 12, and 24 hours postoperatively) for PONV incidence and severity, along with the need for rescue medication. Side effects such as headache, dizziness, hypertension, and hyperglycemia will also be monitored.
Statistical Analysis:
Data will be analyzed using chi-square tests and ANOVA to compare outcomes across treatment groups. A p-value < 0.05 will be considered statistically significant.
This study will help determine the most effective and safest antiemetic regimen, guiding clinical decision-making for better PONV management.
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Being tested
- Placebo (Normal Saline), Ondansetron (Zofran), Dexamethasone
- Keywords
- nausea, vomiting, PONV, randomized controlled trial, ondansetron, dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (Normal Saline)Drug
Also called Saline Injection, Inert Solution
Patients in this group will receive an intravenous (IV) injection of normal saline before surgery. This serves as a control group to compare the efficacy of active treatment groups in preventing postoperative nausea and vomiting.
Ondansetron (Zofran)Drug
Also called Zofran, Ondem, Emeset
Patients in this group will receive a single intravenous (IV) dose of Ondansetron 4 mg before surgery. Ondansetron is a selective 5-HT3 receptor antagonist commonly used to prevent nausea and vomiting associated with anesthesia and surgery.
DexamethasoneDrug
Also called Decadron, Dexasone
Patients in this group will receive a single intravenous (IV) dose of Dexamethasone 8 mg before surgery. Dexamethasone is a corticosteroid with anti-inflammatory properties that has been shown to reduce the incidence of PONV by modulating inflammatory pathways and neuroreceptor activity.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Placebo Group (Control) | Placebo comparator | Patients in this group will receive a placebo (normal saline) intravenously before surgery. This group serves as a control to compare the efficacy and safety of the active treatment regimens. Receives: Drug: Placebo (Normal Saline) |
| Arm 2: Ondansetron Group | Active comparator | Patients in this group will receive a single dose of Ondansetron 4 mg IV before surgery. Ondansetron is a 5-hydroxytryptamine type 3 receptors antagonist commonly used for postoperative nausea and vomiting prevention. Receives: Drug: Ondansetron (Zofran) |
| Arm 3: Dexamethasone Group | Active comparator | Patients in this group will receive a single dose of Dexamethasone 8 mg IV before surgery. Dexamethasone is a corticosteroid that has been shown to reduce postoperative nausea and vomiting. Receives: Drug: Dexamethasone |
| Arm: 4 Combination Therapy Group | Active comparator | Patients in this group will receive a combination of Ondansetron 4 mg IV and Dexamethasone 8 mg IV before surgery. The combination therapy is expected to have an additive effect in reducing PONV. Receives: Drug: Ondansetron (Zofran); Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Nausea and Vomiting (PONV)
Defined as the presence of nausea and/or vomiting at any assessment time point (recovery, 2, 4, 6, 12, and 24 hours postoperatively).
Comparison of postoperative nausea and vomiting incidence between the Ondansetron-Dexamethasone and Ondansetron groups.
The need for rescue antiemetic administration as an indicator of postoperative nausea and vomiting severity.
Measured: 24 hours
Secondary outcomes (10)
Severity of Postoperative Nausea and Vomiting (Postoperative Nausea and Vomiting Impact Scale Score)
Assessment of the frequency, severity, and impact of nausea and vomiting on daily activities and quality of life.
Measured using patient-reported responses to the Postoperative Nausea and Vomiting Impact Scale.
Scoring Range: 0 to 6 Minimum Score (0): No impact of nausea or vomiting Maximum Score (6): Severe impact on daily activities Interpretation: Higher scores indicate a worse outcome, with greater severity and impact of PONV.
Measured: 24 hours
Postoperative Pain Scores (Visual Analog Scale Score)
Pain intensity recorded at recovery, 2, 6 and 24 hours postoperatively using the Visual Analog Scale. A 10-point scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain severity.
Comparison of pain levels between the two groups to determine any analgesic effects of dexamethasone.
Measured: 24 hours
Need for Rescue Medication
Frequency and timing of rescue antiemetic administration in both groups. Determines the effectiveness of the interventions in controlling postoperative nausea and vomiting.
Measured: 24 hours
Adverse Effects of Medications
Frequency of ondansetron-related side effects: headache, dizziness, constipation, diarrhea, fatigue, allergic reactions.
Frequency of dexamethasone-related side effects: increased appetite, insomnia, mood changes, fluid retention, hypertension, hyperglycemia.
Measured: 24 hours
Satisfaction with Postoperative Nausea and Vomiting Management
Patient-reported satisfaction levels with nausea and vomiting management, measured using the satisfaction scale in the questionnaire.
Each response is scored on a 5-point Likert scale, where:
- = Very dissatisfied (minimum score)
- = Somewhat dissatisfied
- = Neutral
- = Somewhat satisfied
- = Very satisfied (maximum score) The total score ranges from 5 (minimum satisfaction) to 25 (maximum satisfaction), with higher scores indicating better patient satisfaction.
Measured: 24 hours
Apfel Score: Risk Assessment for Postoperative Nausea and Vomiting (PONV)
Apfel Score Components (Each Risk Factor = 1 Point) Female gender → (Yes = 1 point, No = 0 points) History of postoperative nausea and vomiting or motion sickness → (Yes = 1 point, No = 0 points) Non-smoker → (Yes = 1 point, No = 0 points) Planned use of postoperative opioid analgesia → (Yes = 1 point, No = 0 points) Higher Apfel Scores indicate an increased risk of postoperative nausea and vomiting.
Measured: 24 hours
Heart Rate
Heart rate (beats per minute) will be continuously monitored and recorded at predefined intraoperative and postoperative time points to assess hemodynamic stability and detect potential bradycardia or tachycardia.
Measured: 24 hours
Blood Pressure
Systolic and diastolic blood pressure (measured in mmHg) will be recorded at regular intraoperative and postoperative intervals to monitor hemodynamic stability and detect episodes of hypotension or hypertension.
Measured: 24 hours
Respiratory Rate
Respiratory rate (measured in breaths per minute) will be monitored intraoperatively and postoperatively to evaluate respiratory function and detect potential respiratory depression or distress.
Measured: 24 hours
Oxygen Saturation
Oxygen saturation levels (SpO₂, measured as a percentage) will be continuously monitored throughout the intraoperative and postoperative periods to assess respiratory function and detect hypoxia.
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 posted20 Mar 2025
- Study start20 Mar 2025
- Primary completion10 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study follows a randomized, parallel-group, single blinded placebo-controlled interventional design to assess the efficacy and safety of Ondansetron, Dexamethasone, and their combination in preventing postoperative nausea and vomiting (PONV).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hafiz Muhammad Hamza
- Sponsor type
- University, hospital or other
- Collaborators
- Federal Government Polyclinic (Postgraduate Medical Institute)
- Responsible party
- Sponsor-investigator, Hafiz Muhammad Hamza, Federal Government Polyclinic (Postgraduate Medical Institute)
- Investigators
- Naveed Ullah Khan, Consultant surgery, HOD, Principal investigator, Federal Government Polyclinic (Postgraduate Medical Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886230
- Sponsor's protocol ID
- FGPC.1/12/2024 E-Committee
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this stage, no final decision has been made regarding the sharing of individual participant data (IPD). Data sharing will be considered based on future research needs, ethical guidelines, and institutional policies. Any decision to share IPD will be made in compliance with data protection regulations and patient confidentiality standards.
Publications
Bhattarai B, Shrestha S, Singh J. Comparison of ondansetron and combination of ondansetron and dexamethasone as a prophylaxis for postoperative nausea and vomiting in adults undergoing elective laparoscopic surgery. J Emerg Trauma Shock. 2011 Apr;4(2):168-72. doi: 10.4103/0974-2700.82200.
PubMed 21769200Thanuja IL, Parida S, Mishra SK, Badhe AS. Effect of combinations of dexamethasone-ondansetron and dexamethasone-ondansetron-aprepitant versus aprepitant alone for early postoperative nausea and vomiting after day care gynaecological laparoscopy: A randomised clinical trial. Indian J Anaesth. 2021 Jun;65(6):465-470. doi: 10.4103/ija.IJA_119_21. Epub 2021 Jun 22.
PubMed 34248190Bilgen S, Kizilcik N, Haliloglu M, Yildirim G, Kaspar EC, Koner O. Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting. Turk J Anaesthesiol Reanim. 2018 Sep;46(5):373-380. doi: 10.10.5152/TJAR.2018.53179. Epub 2018 Sep 4.
PubMed 30263861
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing The Safety and Efficacy of Ondansetron, Dexamethasone, and Their Combined Regimen in Managing Post Operative Nausea and Vomiting: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06886230
- Acronym / sponsor ID
- FGPC.1/12/2024 E-Committee
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- nausea, vomiting, PONV, randomized controlled trial, ondansetron, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hafiz Muhammad HamzaUniversity, hospital or other
- Collaborators
- Federal Government Polyclinic (Postgraduate Medical Institute)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 20 Mar 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.
This randomized controlled trial aims to evaluate the safety and efficacy of Ondansetron, Dexamethasone, and their combination in managing postoperative nausea and vomiting (PONV) in patients undergoing surgery under anesthesia. A total of 100 patients will be randomized into four groups: Placebo, Ondansetron, Dexamethasone, and Ondansetron-Dexamethasone combination. The primary outcome will be the incidence of PONV within 24 hours post-surgery, while secondary outcomes include severity of symptoms, need for rescue medication, adverse effects, and patient satisfaction.
Detailed description
Postoperative nausea and vomiting (PONV) is a common and distressing complication following surgery, affecting patient recovery and satisfaction. This study aims to compare the safety and effectiveness of Ondansetron, Dexamethasone, and their combination for PONV prevention.
The study will be conducted as a randomized, controlled trial at Federal Polyclinic Hospital Islamabad over four months. A total of 100 adult patients undergoing elective surgery under anesthesia will be enrolled and randomly allocated into one of four groups (n=25 each):
Placebo group - Receives no prophylactic antiemetic treatment. Ondansetron group - Receives 4 mg IV Ondansetron before surgery. Dexamethasone group - Receives 8 mg IV Dexamethasone before surgery. Ondansetron-Dexamethasone group - Receives 4 mg IV Ondansetron + 8 mg IV Dexamethasone before surgery.
Methodology:
Patients will be assessed at multiple time points (2, 4, 6, 12, and 24 hours postoperatively) for PONV incidence and severity, along with the need for rescue medication. Side effects such as headache, dizziness, hypertension, and hyperglycemia will also be monitored.
Statistical Analysis:
Data will be analyzed using chi-square tests and ANOVA to compare outcomes across treatment groups. A p-value < 0.05 will be considered statistically significant.
This study will help determine the most effective and safest antiemetic regimen, guiding clinical decision-making for better PONV management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- This study follows a randomized, parallel-group, single blinded placebo-controlled interventional design to assess the efficacy and safety of Ondansetron, Dexamethasone, and their combination in preventing postoperative nausea and vomiting (PONV).
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Placebo Group (Control) | Placebo comparator | Drug: Placebo (Normal Saline)Patients in this group will receive a placebo (normal saline) intravenously before surgery. This group serves as a control to compare the efficacy and safety of the active treatment regimens. |
| Arm 2: Ondansetron Group | Active comparator | Drug: Ondansetron (Zofran)Patients in this group will receive a single dose of Ondansetron 4 mg IV before surgery. Ondansetron is a 5-hydroxytryptamine type 3 receptors antagonist commonly used for postoperative nausea and vomiting prevention. |
| Arm 3: Dexamethasone Group | Active comparator | Drug: DexamethasonePatients in this group will receive a single dose of Dexamethasone 8 mg IV before surgery. Dexamethasone is a corticosteroid that has been shown to reduce postoperative nausea and vomiting. |
| Arm: 4 Combination Therapy Group | Active comparator | Drug: Ondansetron (Zofran), Drug: DexamethasonePatients in this group will receive a combination of Ondansetron 4 mg IV and Dexamethasone 8 mg IV before surgery. The combination therapy is expected to have an additive effect in reducing PONV. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients (≥18 years) scheduled for elective surgery under anesthesia.
- Patients at moderate to high risk for postoperative nausea and vomiting (PONV), as determined by an Apfel risk score ≥2.
- Patients able to provide informed consent or have a legally authorized representative provide consent.
Key exclusion criteria (6 listed)
- Known allergy or hypersensitivity to Ondansetron, Dexamethasone, or any of their components.
- History of significant adverse reactions to previous PONV prophylaxis with Ondansetron or Dexamethasone.
- Pre-existing conditions or medications contraindicating the use of Ondansetron or Dexamethasone, e.g. QT prolongation or severe cardiac arrhythmias (e.g., torsades de pointes, congenital long QT syndrome), Uncontrolled hypertension (for Dexamethasone use), Severe hepatic impairment (Child-Pugh C) or end-stage renal disease, Uncontrolled diabetes mellitus (due to Dexamethasone-induced hyperglycemia).
- Patients with active malignancy undergoing chemotherapy or radiotherapy.
- Pregnant or lactating women (unless safety in this population is specifically being studied).
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 |
|---|---|---|
| Placebo (Normal Saline)Also: Saline Injection, Inert SolutionPatients in this group will receive an intravenous (IV) injection of normal saline before surgery. This serves as a control group to compare the efficacy of active treatment groups in preventing postoperative nausea and vomiting. | Drug | Arm 1: Placebo Group (Control) |
| Ondansetron (Zofran)Also: Zofran, Ondem, EmesetPatients in this group will receive a single intravenous (IV) dose of Ondansetron 4 mg before surgery. Ondansetron is a selective 5-HT3 receptor antagonist commonly used to prevent nausea and vomiting associated with anesthesia and surgery. | Drug | Arm 2: Ondansetron Group, Arm: 4 Combination Therapy Group |
| DexamethasoneAlso: Decadron, DexasonePatients in this group will receive a single intravenous (IV) dose of Dexamethasone 8 mg before surgery. Dexamethasone is a corticosteroid with anti-inflammatory properties that has been shown to reduce the incidence of PONV by modulating inflammatory pathways and neuroreceptor activity. | Drug | Arm 3: Dexamethasone Group, Arm: 4 Combination Therapy Group |
Primary outcome
Incidence of Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hours
Defined as the presence of nausea and/or vomiting at any assessment time point (recovery, 2, 4, 6, 12, and 24 hours postoperatively). Comparison of postoperative nausea and vomiting incidence between the Ondansetron-Dexamethasone and Ondansetron groups. The need for rescue antiemetic administration as an indicator of postoperative nausea and vomiting severity.
10 secondary outcomes
Severity of Postoperative Nausea and Vomiting (Postoperative Nausea and Vomiting Impact Scale Score)
Time frame: 24 hours
Postoperative Pain Scores (Visual Analog Scale Score)
Time frame: 24 hours
Need for Rescue Medication
Time frame: 24 hours
Adverse Effects of Medications
Time frame: 24 hours
Satisfaction with Postoperative Nausea and Vomiting Management
Time frame: 24 hours
Apfel Score: Risk Assessment for Postoperative Nausea and Vomiting (PONV)
Time frame: 24 hours
Heart Rate
Time frame: 24 hours
Blood Pressure
Time frame: 24 hours
Respiratory Rate
Time frame: 24 hours
Oxygen Saturation
Time frame: 24 hours
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 Jun 2025.
- Background: PubMed 21769200Bhattarai B, Shrestha S, Singh J. Comparison of ondansetron and combination of ondansetron and dexamethasone as a prophylaxis for postoperative nausea and vomiting in adults undergoing elective laparoscopic surgery. J Emerg Trauma Shock. 2011 Apr;4(2):168-72. doi: 10.4103/0974-2700.82200.
- Background: PubMed 34248190Thanuja IL, Parida S, Mishra SK, Badhe AS. Effect of combinations of dexamethasone-ondansetron and dexamethasone-ondansetron-aprepitant versus aprepitant alone for early postoperative nausea and vomiting after day care gynaecological laparoscopy: A randomised clinical trial. Indian J Anaesth. 2021 Jun;65(6):465-470. doi: 10.4103/ija.IJA_119_21. Epub 2021 Jun 22.
- Background: PubMed 30263861Bilgen S, Kizilcik N, Haliloglu M, Yildirim G, Kaspar EC, Koner O. Effect of the Dexamethasone-Ondansetron Combination Versus Dexamethasone-Aprepitant Combination to Prevent Postoperative Nausea and Vomiting. Turk J Anaesthesiol Reanim. 2018 Sep;46(5):373-380. doi: 10.10.5152/TJAR.2018.53179. Epub 2018 Sep 4.
- Dexamethasone, ondansetron, and their combination and postoperative nausea and vomiting in children undergoing strabismus surgery: a meta-analysis of randomized controlled trialsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this stage, no final decision has been made regarding the sharing of individual participant data (IPD). Data sharing will be considered based on future research needs, ethical guidelines, and institutional policies. Any decision to share IPD will be made in compliance with data protection regulations and patient confidentiality standards.
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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.
Naveed Ullah Khan, Consultant surgery, HOD principal investigator
Federal Government Polyclinic (Postgraduate Medical Institute)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron (Zofran) and Dexamethasone in people with Postoperative Nausea and Vomiting (PONV), run by Hafiz Muhammad Hamza at 1 site in Pakistan.
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 6 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 Jun 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 Pakistan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Incidence of Postoperative Nausea and Vomiting (PONV) (time frame: 24 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 NCT06886230, which also lists 3 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 17 Jun 2025.