Postoperative Nausea and VomitingNCT04719741
Drug and Dose Adjustment in Preventing Postoperative Nausea and Vomiting
An observational study of Postoperative Nausea and Vomiting, run by Jordan Hospital at 1 site in Jordan.
Trial summary
The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Parallel Assignment
- How many people
- 1,000 participants
- Where
- 1 siteJordan
- Study dates
- 1 May 2023to 20 Aug 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective surgery under general anesthesia
Who may be able to join
- ASA grade I and II
- Aged 18-70 years
- Patients scheduled for elective surgery under general anesthesia
Who cannot join
- All patients who received antiemetics or cortisone within 48 hr before surgery
- Pregnant, breast feeding ladies
- Any patient with BMI (Body Mass Index) > 34 kg/m²
- Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses were also excluded from the study protocol.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
Jordan Hospital
Amman, 11152
AbdulRhman MA Ibnouf, MBBS, +962786468830, ibnouf@hotmail.com
About this study
Official title: Drug and Dosage Adjustment in Preventing Postoperative Nausea and Vomiting in Adult Patients Undergoing Elective Surgery Under General Anesthesia
The aim is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.
Read the detailed description
Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Parallel Assignment
- Keywords
- nausea, vomiting, postoperative, dose adjustment
- 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.
Parallel AssignmentOther
Prospective, Triple blinded, randomized, controlled trial
| Study group | Role | What they receive |
|---|---|---|
| O-4PI | 4 mg Ondansetron given Pre-Induction Receives: Other: Parallel Assignment | |
| O-8PI | 8 mg Ondansetron given Pre-Induction Receives: Other: Parallel Assignment | |
| O-4PE | 4 mg Ondansetron given Pre-Emergence Receives: Other: Parallel Assignment | |
| O-8PE | 8 mg Ondansetron given Pre-Emergence Receives: Other: Parallel Assignment | |
| D-4PI | 4 mg Dexamethasone given Pre-Induction Receives: Other: Parallel Assignment | |
| D-8PI | 8 mg Dexamethasone given Pre-Induction Receives: Other: Parallel Assignment | |
| D-4PE | 4 mg Dexamethasone given Pre-Emergence Receives: Other: Parallel Assignment | |
| D-8PE | 8 mg Dexamethasone given Pre-Emergence Receives: Other: Parallel Assignment | |
| O-4PI+D-8PI | 4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction Receives: Other: Parallel Assignment | |
| O-4PI+D-8PE | 4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence Receives: Other: Parallel Assignment | |
| O-4PE+D-8PI | 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction Receives: Other: Parallel Assignment | |
| O-4PE+D-8PE | 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence Receives: Other: Parallel Assignment | |
| Placebo Group | 2 ml Saline 0.9% Receives: Other: Parallel Assignment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of postoperative nausea and/or vomiting
Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs
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 posted22 Jan 2021
- Study start1 May 2023 (estimated)
- Primary completion20 May 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Jordan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AbdulRhman MA. M. Ibnouf, Jordan Hospital
- Investigators
- AbdulRhman MA Ibnouf, MBBS, Study director, Anaesthesia Department, Jordan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04719741
- Sponsor's protocol ID
- JHANES000001
- Status last verified
- Mar 2022
- First submitted
- 17 Jan 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug and Dosage Adjustment in Preventing Postoperative Nausea and Vomiting in Adult Patients Undergoing Elective Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04719741
- Acronym / sponsor ID
- JHANES000001
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- nausea, vomiting, postoperative, dose adjustment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Jordan HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 22 Jan 2021 (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 is to evaluate the effectiveness of different regimens of prophylactic Ondansetron, Dexamethasone, or both, on the incidence and severity of post-operative nausea and vomiting.
Detailed description
Patients will be randomized to one of four arms: Ondansetron (4O-PE: 4 mg Ondansetron pre-emergence, 8O-PE: 8 mg Ondansetron pre-emergence, 4O-PI: 4 mg Ondansetron pre-incision, 8O-PI: 8 mg Ondansetron pre-incision), Dexamethasone (4D-PE: 4 mg Dexamethasone pre-emergence, 8D-PE: 8 mg Dexamethasone pre-emergence, or 4D-PI: 4 mg Dexamethasone pre-incision, or 8D-PI: 8 mg Dexamethasone pre-incision), Combination Therapy group (4O-PI+8D-PI: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-incision, 4O-PI+8D-PE: 4 mg Ondansetron pre-incision + 8 mg Dexamethasone pre-emergence, 4 O-PE+8D-PI: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction, 4 O-PE+8D-PE: 4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence), and Placebo group 2 ml Saline 0.9%. Primary outcome will be the incidence of PONV in the PACU prior to discharge.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 13
| Arm | Type | Receives |
|---|---|---|
| O-4PI | – | Other: Parallel Assignment4 mg Ondansetron given Pre-Induction |
| O-8PI | – | Other: Parallel Assignment8 mg Ondansetron given Pre-Induction |
| O-4PE | – | Other: Parallel Assignment4 mg Ondansetron given Pre-Emergence |
| O-8PE | – | Other: Parallel Assignment8 mg Ondansetron given Pre-Emergence |
| D-4PI | – | Other: Parallel Assignment4 mg Dexamethasone given Pre-Induction |
| D-8PI | – | Other: Parallel Assignment8 mg Dexamethasone given Pre-Induction |
| D-4PE | – | Other: Parallel Assignment4 mg Dexamethasone given Pre-Emergence |
| D-8PE | – | Other: Parallel Assignment8 mg Dexamethasone given Pre-Emergence |
| O-4PI+D-8PI | – | Other: Parallel Assignment4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-induction |
| O-4PI+D-8PE | – | Other: Parallel Assignment4 mg Ondansetron pre-induction+ 8 mg Dexamethasone pre-emergence |
| O-4PE+D-8PI | – | Other: Parallel Assignment4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-induction |
| O-4PE+D-8PE | – | Other: Parallel Assignment4 mg Ondansetron pre-emergence + 8 mg Dexamethasone pre-emergence |
| Placebo Group | – | Other: Parallel Assignment2 ml Saline 0.9% |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective surgery under general anesthesia
Key inclusion criteria (3 listed)
- ASA grade I and II
- Aged 18-70 years
- Patients scheduled for elective surgery under general anesthesia
Key exclusion criteria (4 listed)
- All patients who received antiemetics or cortisone within 48 hr before surgery
- Pregnant, breast feeding ladies
- Any patient with BMI (Body Mass Index) > 34 kg/m²
- Patient with gastrointestinal, hepatic, renal, mental or psychiatric illnesses were also excluded from the study protocol.
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 |
|---|---|---|
| Parallel AssignmentProspective, Triple blinded, randomized, controlled trial | Other | D-4PE, D-4PI, D-8PE, D-8PI, O-4PE, O-4PE+D-8PE, O-4PE+D-8PI, O-4PI, O-4PI+D-8PE, O-4PI+D-8PI, O-8PE, O-8PI, Placebo Group |
Primary outcome
Presence of postoperative nausea and/or vomiting
Time frame: 24 hours
Follow if the patient complained about postoperative nausea and/or vomiting in terms of use of antiemetic drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: Undecided
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A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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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.
AbdulRhman MA Ibnouf, MBBS study director
Anaesthesia Department, Jordan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting, run by Jordan Hospital at 1 site in Jordan.
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 4 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: status not confirmed, as of the sponsor's last update on 29 Mar 2022. 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 Jordan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact AbdulRhman MA Ibnouf, MBBS (+962786468830, ibnouf@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of postoperative nausea and/or vomiting (time frame: 24 hours). 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 29 Mar 2022.