Postoperative Nausea and VomitingPhase 2/3PONVNCT02525848
Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
A Phase 2/3 study testing dexamethasone, Gabapentin and Aprepitant in people with Postoperative Nausea and Vomiting, run by Assiut University at 1 site in Egypt.
Trial summary
To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- dexamethasone, Gabapentin and Aprepitant
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2015to Mar 2016
- Phase
- Phase 2/3
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia.
Who cannot join
- Central or peripheral neurological pathologies.
- History of drug abuse, chronic pain, or psychiatric disorders.
- Pregnant women
- Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.
Read the detailed description
Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery room. Laparoscopic surgery is one important risk factor for increased incidence of PONV. Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting.
Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of substance P. Substance P is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- dexamethasone, Gabapentin, Aprepitant
- 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
Also called Decadron
dexamethasone 8 mg iv 2 minutes before induction of anesthesia
GabapentinDrug
Also called Neurontin
oral gabapentin 600 mg 1 hour before induction of anesthesia
AprepitantDrug
Also called Emend
oral aprepitan 80mg 1 hour before induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone | Active comparator | intravenous dexamethasone 8 mg 2 minutes before induction of anesthesia; Receives: Drug: dexamethasone |
| gapabentin | Active comparator | oral gabapentin 600 mg 1 hour before induction of anesthesia Receives: Drug: dexamethasone; Drug: Gabapentin |
| Aprepitant | Active comparator | aprepitan 80mg 1 hour before induction of anesthesia. Receives: Drug: dexamethasone; Drug: Aprepitant |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence (%) of postoperative nausea and vomiting
The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.
Measured: 24 hours postoperative
Secondary outcomes (3)
non invasive blood pressure
Noninvasive blood pressure measured immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery
Measured: intra-operative from induction of general anesthesia till end of surgery.
heart rate
heart rate recorded immediately after induction of anesthesia ,15 min.30 min.45 min. and 60 min till the end of surgery
Measured: Intra-operative from induction of anesthesia till end of surgery.
side effects
Side effects of given drugs will be treated and recorded
Measured: 24 h postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionMar 2016
- Study completionMar 2016
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02525848
- Sponsor's protocol ID
- IRB00008718/ reference no. 104
- Acronym
- PONV
- Status last verified
- Mar 2016
- First submitted
- 14 Aug 2015
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aprepitant Versus Gabapentin Prophylaxis for Postoperative Nausea and Vomiting in Laparoscopic Gynecological Surgeries
- ClinicalTrials.gov ID
- NCT02525848
- Acronym / sponsor ID
- PONV / IRB00008718/ reference no. 104
- Conditions
- Postoperative Nausea and Vomiting
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Aug 2015 (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.
To evaluate the efficacy of pre-empetive administration of Aprepitant, Versus Gabapentin prophylaxis for reducing the incidence of postoperative nausea and vomiting in Laproscopic gynacological surgeries.
Detailed description
Postoperative nausea and vomiting (PONV) is frequently encountered in the surgical recovery room. Laparoscopic surgery is one important risk factor for increased incidence of PONV. Gabapentin, an anticonvulsant with known postoperative analgesic properties, has shown some activity against PONV. Results from clinical trials evaluating the anti-emetic efficacy of gabapentin are conflicting.
Aprepitant, a neurokinin-1 (NK1) receptor antagonist, blockades the central effects of substance P. Substance P is a neurotransmitter found in central areas associated with emesis such as the dorsal vagal complex and area postrema.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dexamethasone | Active comparator | Drug: dexamethasoneintravenous dexamethasone 8 mg 2 minutes before induction of anesthesia; |
| gapabentin | Active comparator | Drug: dexamethasone, Drug: Gabapentinoral gabapentin 600 mg 1 hour before induction of anesthesia |
| Aprepitant | Active comparator | Drug: dexamethasone, Drug: Aprepitantaprepitan 80mg 1 hour before induction of anesthesia. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA physical status I and II aged between 18 and 45 yrs. They undergo Laproscopic gynacological surgeries under general anesthesia.
Key exclusion criteria (4 listed)
- Central or peripheral neurological pathologies.
- History of drug abuse, chronic pain, or psychiatric disorders.
- Pregnant women
- Patients who took sedatives, antiemetics, or antipruritics within 24 hrs of operation.
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 |
|---|---|---|
| dexamethasoneAlso: Decadrondexamethasone 8 mg iv 2 minutes before induction of anesthesia | Drug | Aprepitant, dexamethasone, gapabentin |
| GabapentinAlso: Neurontinoral gabapentin 600 mg 1 hour before induction of anesthesia | Drug | gapabentin |
| AprepitantAlso: Emendoral aprepitan 80mg 1 hour before induction of anesthesia. | Drug | Aprepitant |
Primary outcome
incidence (%) of postoperative nausea and vomiting
Time frame: 24 hours postoperative
The incidence (%) of PONV will be recorded each 6 hours until 24 hours after discharge from the PACU.
3 secondary outcomes
non invasive blood pressure
Time frame: intra-operative from induction of general anesthesia till end of surgery.
heart rate
Time frame: Intra-operative from induction of anesthesia till end of surgery.
side effects
Time frame: 24 h postoperative.
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 24 Mar 2016.
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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.
Hala S Abdel-Ghaffar, MD principal investigator
Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing dexamethasone, Gabapentin and Aprepitant 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 1 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: finished, as of the sponsor's last update on 24 Mar 2016. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 (time frame: 24 hours postoperative). 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 24 Mar 2016; AzTrials last refreshed its copy on 31 Oct 2026.