Postoperative Nausea and Vomiting (PONV)PONV-DEX-GYNNCT07421817
Dexamethasone for Prevention of Postoperative Vomiting After Laparoscopic Gynecologic Surgery
A study testing Dexamethasone in people with Postoperative Nausea and Vomiting (PONV), run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
Postoperative nausea and vomiting (PONV) are common and distressing complications following laparoscopic gynecologic surgery. This randomized controlled trial evaluated whether a single preoperative intravenous dose of dexamethasone reduces postoperative vomiting compared with placebo and explored patient-related risk… Read more about this study
- Who is it for?
- Ages 15 to 65 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting (PONV)
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Oct 2017to 31 Mar 2018
- Phase
- Interventional
- 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 15 to 65 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female patients aged 15-65 years
- Scheduled for elective laparoscopic gynecologic surgery
- Able to provide written informed consent (for minors, consent obtained from legal guardians)
Who cannot join
- Prior laparoscopic surgery
- Known hypersensitivity to corticosteroids
- Opioid use within 24 hours preoperatively
- Ischemic heart disease
- Uncontrolled hypertension or diabetes mellitus
- Ongoing antiemetic therapy
- Conversion to open surgery
- Body mass index (BMI) > 30 kg/m²
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Gynecology and Obstetrics, Al-Nafees Medical College and Hospital-Isra University
Islamabad, ICT, 44000
About this study
Official title: Effect of a Preoperative Single Dose of Intravenous Dexamethasone on Postoperative Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
Postoperative nausea and vomiting (PONV) are common and distressing complications following laparoscopic gynecologic surgery. This randomized controlled trial evaluated whether a single preoperative intravenous dose of dexamethasone reduces postoperative vomiting compared with placebo and explored patient-related risk factors associated with PONV.
Women undergoing elective laparoscopic gynecologic surgery were randomly assigned to receive dexamethasone (5 mg IV) or placebo at induction of anesthesia. The primary outcome was the incidence of postoperative vomiting within 24 hours, with secondary outcomes including nausea severity, rescue antiemetic use, and postoperative recovery parameters.
Read the detailed description
This single-blind randomized controlled trial evaluated the prophylactic efficacy of a single preoperative intravenous dose of dexamethasone for preventing postoperative vomiting in women undergoing elective laparoscopic gynecologic surgery. The study was conducted at Holy Family Hospital, Rawalpindi Medical University, Pakistan, between October 1, 2017, and March 31, 2018.
Eligible women aged 15-65 years were randomized in a 1:1 ratio to receive either dexamethasone 5 mg intravenously or placebo (normal saline) at induction of anesthesia. Perioperative anesthesia and postoperative care were standardized across groups. The primary outcome was the incidence of postoperative vomiting within 24 hours after surgery. Secondary outcomes included nausea severity, need for rescue antiemetics, postoperative opioid use, and recovery parameters such as time to oral intake and mobilization. An exploratory analysis assessed patient-related predictors of postoperative nausea and vomiting, including body mass index and prior history of PONV.
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Being tested
- Dexamethasone, Placebo (Normal Saline)
- Keywords
- postoperative nausea and vomiting (PONV), dexamethasone, laparoscopic gynecologic surgery, prophylaxis, risk factors
- 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.
DexamethasoneDrug
Single intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision.
Placebo (Normal Saline)Other
Single intravenous dose of 2 mL normal saline (placebo) administered at induction of anesthesia immediately prior to surgical incision, matched in volume to the dexamethasone administered in the experimental arm.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Single intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision. Receives: Drug: Dexamethasone |
| Placebo (Normal Saline) | Placebo comparator | Single intravenous dose of normal saline (placebo) administered at induction of anesthesia. Receives: Other: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative vomiting
Proportion of participants experiencing at least one episode of vomiting within 24 hours after surgery.
Measured: Within 24 hours after surgery
Secondary outcomes (1)
Need for rescue antiemetics
Proportion of participants requiring rescue antiemetic medication within 24 hours postoperatively.
Measured: Within 24 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 posted19 Feb 2026
- Study start1 Oct 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized 1:1 to receive either intravenous dexamethasone (5 mg) or placebo at induction of anesthesia, with parallel group assignment.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fizza Fatima, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421817
- Sponsor's protocol ID
- 101/RMU/2017-09-29
- Acronym
- PONV-DEX-GYN
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to local institutional policies and consent limitations. De-identified aggregate data are available from the corresponding author upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Preoperative Single Dose of Intravenous Dexamethasone on Postoperative Vomiting in Patients Undergoing Laparoscopic Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT07421817
- Acronym / sponsor ID
- PONV-DEX-GYN / 101/RMU/2017-09-29
- Conditions
- Postoperative Nausea and Vomiting (PONV)
- Keywords
- postoperative nausea and vomiting (PONV), dexamethasone, laparoscopic gynecologic surgery, prophylaxis, risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 19 Feb 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.
Postoperative nausea and vomiting (PONV) are common and distressing complications following laparoscopic gynecologic surgery. This randomized controlled trial evaluated whether a single preoperative intravenous dose of dexamethasone reduces postoperative vomiting compared with placebo and explored patient-related risk factors associated with PONV.
Women undergoing elective laparoscopic gynecologic surgery were randomly assigned to receive dexamethasone (5 mg IV) or placebo at induction of anesthesia. The primary outcome was the incidence of postoperative vomiting within 24 hours, with secondary outcomes including nausea severity, rescue antiemetic use, and postoperative recovery parameters.
Detailed description
This single-blind randomized controlled trial evaluated the prophylactic efficacy of a single preoperative intravenous dose of dexamethasone for preventing postoperative vomiting in women undergoing elective laparoscopic gynecologic surgery. The study was conducted at Holy Family Hospital, Rawalpindi Medical University, Pakistan, between October 1, 2017, and March 31, 2018.
Eligible women aged 15-65 years were randomized in a 1:1 ratio to receive either dexamethasone 5 mg intravenously or placebo (normal saline) at induction of anesthesia. Perioperative anesthesia and postoperative care were standardized across groups. The primary outcome was the incidence of postoperative vomiting within 24 hours after surgery. Secondary outcomes included nausea severity, need for rescue antiemetics, postoperative opioid use, and recovery parameters such as time to oral intake and mobilization. An exploratory analysis assessed patient-related predictors of postoperative nausea and vomiting, including body mass index and prior history of PONV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomized 1:1 to receive either intravenous dexamethasone (5 mg) or placebo at induction of anesthesia, with parallel group assignment.
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneSingle intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision. |
| Placebo (Normal Saline) | Placebo comparator | Other: Placebo (Normal Saline)Single intravenous dose of normal saline (placebo) administered at induction of anesthesia. |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients aged 15-65 years
- Scheduled for elective laparoscopic gynecologic surgery
- Able to provide written informed consent (for minors, consent obtained from legal guardians)
Key exclusion criteria (8 listed)
- Prior laparoscopic surgery
- Known hypersensitivity to corticosteroids
- Opioid use within 24 hours preoperatively
- Ischemic heart disease
- Uncontrolled hypertension or diabetes mellitus
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 |
|---|---|---|
| DexamethasoneSingle intravenous dose of dexamethasone 5 mg administered at induction of anesthesia prior to surgical incision. | Drug | Dexamethasone |
| Placebo (Normal Saline)Single intravenous dose of 2 mL normal saline (placebo) administered at induction of anesthesia immediately prior to surgical incision, matched in volume to the dexamethasone administered in the experimental arm. | Other | Placebo (Normal Saline) |
Primary outcome
Incidence of postoperative vomiting
Time frame: Within 24 hours after surgery
Proportion of participants experiencing at least one episode of vomiting within 24 hours after surgery.
1 secondary outcome
Need for rescue antiemetics
Time frame: Within 24 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 20 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to local institutional policies and consent limitations. De-identified aggregate data are available from the corresponding author upon reasonable request.
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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 study testing Dexamethasone in people with Postoperative Nausea and Vomiting (PONV), run by Rawalpindi Medical College 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 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 20 Feb 2026. 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.
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 vomiting (time frame: Within 24 hours after surgery). 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 20 Feb 2026.