Postoperative Nausea and VomitingNCT02947672
Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting
A study testing Intravenous Dexamethasone and Intraperitoneal Dexamesathone in people with Postoperative Nausea and Vomiting, run by Assiut University at 1 site in Egypt.
Trial summary
Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative nausea and vomiting following Laparoscopic gynecological surgeries. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Intravenous Dexamethasone and Intraperitoneal Dexamesathone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2016to Nov 2017
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult Female patients
- American society of anesthesiologist class I \& II
- Undergoing Laparoscopic gynecological surgeries
Who cannot join
- Patient refusal to participate in the study
- Patients with coagulopathy or under anticoagulation therapy.
- Infection near the site of needle insertion.
- Body mass index > 40kg/m2
- Patients with any neurological or neuromuscular disorder or history of seizures.
- Known allergy to any drug used in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting Following Laparoscopic Gynecological Surgeries
Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative nausea and vomiting following Laparoscopic gynecological surgeries.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Intravenous Dexamethasone, Intraperitoneal Dexamesathone
- 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.
Intravenous DexamethasoneDrug
Intraperitoneal DexamesathoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Intravenous dexamethasone | Active comparator | 50 patients will receive intravenous dexamethasone Receives: Drug: Intravenous Dexamethasone |
| Intra peritoneal dexamethasone | Active comparator | 50 patients will receive intraperitoneal dexamethasone Receives: Drug: Intraperitoneal Dexamesathone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting (PONV)
PONV will be measured by using Verbal Descriptive Scale
Measured: 24 hours
Secondary outcomes (1)
Pain
Pain will be assessed by using visual analogue scale
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 posted28 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017
- Study completionNov 2017
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman A. Ismail, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947672
- Sponsor's protocol ID
- 01003060377
- Status last verified
- Feb 2018
- First submitted
- 24 Oct 2016
- Last updated
- 13 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Versus Intra-peritoneal Dexamethasone on the Incidence of Postoperative Nausea and Vomiting Following Laparoscopic Gynecological Surgeries
- ClinicalTrials.gov ID
- NCT02947672
- Acronym / sponsor ID
- 01003060377
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
Effect of intravenous versus intra-peritoneal dexamethasone on the incidence of postoperative nausea and vomiting following Laparoscopic gynecological surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous dexamethasone | Active comparator | Drug: Intravenous Dexamethasone50 patients will receive intravenous dexamethasone |
| Intra peritoneal dexamethasone | Active comparator | Drug: Intraperitoneal Dexamesathone50 patients will receive intraperitoneal dexamethasone |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult Female patients
- American society of anesthesiologist class I \& II
- Undergoing Laparoscopic gynecological surgeries
Key exclusion criteria (6 listed)
- Patient refusal to participate in the study
- Patients with coagulopathy or under anticoagulation therapy.
- Infection near the site of needle insertion.
- Body mass index > 40kg/m2
- Patients with any neurological or neuromuscular disorder or history of seizures.
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 |
|---|---|---|
| Intravenous Dexamethasone | Drug | Intravenous dexamethasone |
| Intraperitoneal Dexamesathone | Drug | Intra peritoneal dexamethasone |
Primary outcome
Postoperative nausea and vomiting (PONV)
Time frame: 24 hours
PONV will be measured by using Verbal Descriptive Scale
1 secondary outcome
Pain
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 13 Feb 2018.
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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 Intravenous Dexamethasone and Intraperitoneal Dexamesathone in people with Postoperative Nausea and Vomiting, run by Assiut University at 1 site in Egypt.
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 13 Feb 2018. 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 Egypt. 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?
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?
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?
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 13 Feb 2018.