Postoperative Nausea and VomitingPhase 4NCT04538820
Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients
A Phase 4 study testing Dexamethasone 4 mg IV and Dexamethasone 8 mg IV in people with Postoperative Nausea and Vomiting, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone 4 mg IV and Dexamethasone 8 mg IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 30 Sep 2021
- 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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High risk patients for postoperative nausea and vomiting:
- Female
- No smoking
- BMI =18.5-24.9 for control group
- BMI >30 for other groups
- undergo laparoscopic cholecystectomy
Who cannot join
- Diabetes mellitus
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
DiskapiYBERH
Ankara
Bahar SAKIZCI UYAR, drsakizciuyar@gmail.com
About this study
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients.
Read the detailed description
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients.
compare the effectiveness of dexamethasone given in 4 mg and 8 mg doses in obese patients with 4 mg doses of dexamethasone in normal weight patients.
4 mg iv dexamethasone will be administered to normal weight patients at induction of anesthesia. This group will be classified as the control group. In obese patients (BMI>30 kg/m2), one group will receive 4 mg dexamethasone and other group will receive 8 mg dexamethasone at induction.
Patients will receive general anesthesia with volatile anesthetics and tramadol will be administered IV at the end of surgery.
Postoperative nausea and vomiting, postoperative pain, blood glucose, wound infection, time to oral intake, hospital stay will be compared.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Dexamethasone 4 mg IV-control, Dexamethasone 4 mg IV, Dexamethasone 8 mg IV
- 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.
Dexamethasone 4 mg IV-controlDrug
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients.
Dexamethasone 4 mg IVDrug
dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
Dexamethasone 8 mg IVDrug
dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
| Study group | Role | What they receive |
|---|---|---|
| control | Active comparator | patients with BMI=18.5-24.9 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. Receives: Drug: Dexamethasone 4 mg IV-control |
| 4 mg | Active comparator | patients with BMI>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. Receives: Drug: Dexamethasone 4 mg IV |
| 8 mg | Active comparator | patients with BMI>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. Receives: Drug: Dexamethasone 8 mg IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative nausea and vomiting (PONV)
The primary outcome is the overall incidence of PONV during the first 24 h, defined as any episode of vomiting or nausea.Nausea will be measured using an 11-point verbal rating scale (VRS) running from 0 (no nausea) to 10 (the worst nausea imaginable). We will define severe PONV as nausea with a score of at least 4 on the VRS, or vomiting.
Measured: PONV scores wİll be record during the first 24 hours
Secondary outcomes (5)
postoperative pain: 11-point VRS
Pain intensity will be measured using a simple 11-point VRS running from 0 (no pain) to 10 (unbearable pain), at rest and on mobilisation (asking the patient to cough).
Measured: Pain will be assessed during the first 24 hours
oral intake
patients will be asked first oral fluid intake time charge criteria.
Measured: during the first 24 hours
blood glucose
Fingerprick capillary blood glucose concentrations will be measured
Measured: at 6 and 10 hours after administration of dexamethasone
Length of Hospital Stay
the time will be recorded when patients are discharged home
Measured: during the first 24 hours
wound infection
Patients will be telephone on the 30th postoperative day and questioned in terms of wound infection
Measured: postoperative 30th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Mar 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bahar SAKIZCI UYAR, Diskapi Yildirim Beyazit Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538820
- Sponsor's protocol ID
- 92/07
- Status last verified
- Sep 2021
- First submitted
- 13 Aug 2020
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients
- ClinicalTrials.gov ID
- NCT04538820
- Acronym / sponsor ID
- 92/07
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Diskapi Yildirim Beyazit Education and Research HospitalOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 4 Sep 2020 (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.
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients and in normal weight patients.
Detailed description
compare the effectiveness of different doses of dexamethasone used for postoperative nausea and vomiting prophylaxis in obese patients.
compare the effectiveness of dexamethasone given in 4 mg and 8 mg doses in obese patients with 4 mg doses of dexamethasone in normal weight patients.
4 mg iv dexamethasone will be administered to normal weight patients at induction of anesthesia. This group will be classified as the control group. In obese patients (BMI>30 kg/m2), one group will receive 4 mg dexamethasone and other group will receive 8 mg dexamethasone at induction.
Patients will receive general anesthesia with volatile anesthetics and tramadol will be administered IV at the end of surgery.
Postoperative nausea and vomiting, postoperative pain, blood glucose, wound infection, time to oral intake, hospital stay will be compared.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | Active comparator | Drug: Dexamethasone 4 mg IV-controlpatients with BMI=18.5-24.9 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. |
| 4 mg | Active comparator | Drug: Dexamethasone 4 mg IVpatients with BMI>30 kg/m2 will be received 4 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. |
| 8 mg | Active comparator | Drug: Dexamethasone 8 mg IVpatients with BMI>30 kg/m2 will be received 8 mg dexamethasone at induction of anesthesia for postoperative nausea and vomiting prophylaxis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female
- No smoking
- BMI =18.5-24.9 for control group
- BMI >30 for other groups
- undergo laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- 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 |
|---|---|---|
| Dexamethasone 4 mg IV-controldexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients. | Drug | control |
| Dexamethasone 4 mg IVdexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients | Drug | 4 mg |
| Dexamethasone 8 mg IVdexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients | Drug | 8 mg |
Primary outcome
postoperative nausea and vomiting (PONV)
Time frame: PONV scores wİll be record during the first 24 hours
The primary outcome is the overall incidence of PONV during the first 24 h, defined as any episode of vomiting or nausea.Nausea will be measured using an 11-point verbal rating scale (VRS) running from 0 (no nausea) to 10 (the worst nausea imaginable). We will define severe PONV as nausea with a score of at least 4 on the VRS, or vomiting.
5 secondary outcomes
postoperative pain: 11-point VRS
Time frame: Pain will be assessed during the first 24 hours
oral intake
Time frame: during the first 24 hours
blood glucose
Time frame: at 6 and 10 hours after administration of dexamethasone
Length of Hospital Stay
Time frame: during the first 24 hours
wound infection
Time frame: postoperative 30th day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
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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.
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 Dexamethasone 4 mg IV and Dexamethasone 8 mg IV in people with Postoperative Nausea and Vomiting, run by Diskapi Yildirim Beyazit Education and Research Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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 8 Sep 2021. 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 Turkey (Türkiye). 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bahar SAKIZCI UYAR (5057000240, drsakizciuyar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative nausea and vomiting (PONV) (time frame: PONV scores wİll be record during the first 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 8 Sep 2021.