Postoperative Nausea and VomitingPhase 4NCT02021851
Prevention of Nausea and Vomiting in Patients After Surgery
A Phase 4 study testing Dexamethasone and aprepitant and Dexamethasone and ondansetron in people with Postoperative Nausea and Vomiting, run by Yeditepe University Hospital at 1 site in Turkey (Türkiye).
Trial summary
Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Dexamethasone and aprepitant and Dexamethasone and ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jul 2011to Jul 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 Years to 60 Years
- ASA (American Society of Anesthesiologist) physical status I or II
- Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy
Who cannot join
- Hypersensitivity or contraindication to the study medications,
- Antiemetic drug or steroid use within 24 hours before anesthesia,
- History of diabetes mellitus,
- History of motion sickness or postoperative nausea and vomiting,
- Pregnancy,
- Breast feeding
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yeditepe University Hospital
Devlet Yolu, Ankara Cad 102/104, Kozyatagi Istanbul, 34752
About this study
Official title: THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY
Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.
Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.
PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Dexamethasone and aprepitant, Dexamethasone and ondansetron
- Keywords
- Dexamethasone,, Ondansetron, Aprepitant, PONV, Laparoscopic surgery
- 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 and aprepitantDrug
Dexamethasone and ondansetronDrug
| Study group | Role | What they receive |
|---|---|---|
| Group DA: Dexamethasone and aprepitant | Active comparator | Group DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral) Receives: Drug: Dexamethasone and aprepitant |
| Group DO: Dexamethasone and ondansetron | Placebo comparator | Group DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous) Receives: Drug: Dexamethasone and ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response
The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.
Measured: One year
Secondary outcomes (4)
Nausea
The secondary outcome measure is incidence of nausea
Measured: One year
Retching
The secondary outcome measure is incidence of retching
Measured: One year
Vomiting
The secondary outcome measure is incidence of vomiting
Measured: One year
Need of rescue antiemetic
The secondary outcome measure is incidence of the need of rescue antiemetic within 24 hours after surgery.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJul 2011
- Primary completionJul 2012
- Study completionJul 2012
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Bilgen, Yeditepe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021851
- Sponsor's protocol ID
- 125
- Status last verified
- Dec 2013
- First submitted
- 9 Dec 2013
- Last updated
- 27 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY
- ClinicalTrials.gov ID
- NCT02021851
- Acronym / sponsor ID
- 125
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Dexamethasone,, Ondansetron, Aprepitant, PONV, Laparoscopic surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Yeditepe University HospitalUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 27 Dec 2013 (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.
Postoperative nausea and vomiting (PONV) is a common problem after general anesthesia. The incidence can be as high as 80 percent in high-risk patients. Investigators designed this randomized, double- blind, single-center study to compare the efficacy of the combination of dexamethasone with ondansetron and dexamethasone with aprepitant undergoing laparoscopic surgery.
Seventy American Society of Anesthesiologist (ASA) physical class I-II, age 18-60 years patients scheduled for laparoscopic surgery were included in this study. Anesthesia was induced with propofol, fentanyl, and rocuronium, and maintained with sevoflurane in oxygen / air mixture in all patients. Remifentanil was continuously infused during surgery. Patients were randomly divided into two groups. Patients in the dexamethasone and aprepitant group (group DA, n=35) received 40 mg aprepitant orally 1 to 2 hours before induction of anesthesia and 2 ml saline intravenous (iv) within the last 30 minutes of surgery. Patients in the dexamethasone and ondansetron group (group DO, n=35) received an oral placebo identical to aprepitant 1 to 2 hours before induction of anesthesia and 4 mg ondansetron iv within the last 30 minutes of surgery. All patient received iv 8 mg dexamethasone after induction of anesthesia.
PONV and postoperative opioid consumption were assessed for 24 hours postoperatively. The blindly evaluated primary outcome was complete response. The secondary outcomes were incidence of nausea, retching or vomiting, the need of rescue antiemetic and opioid consumption within 24 hours after surgery. Statistical analyses were performed using Mann-Whitney U test, Chi-square test, and Fisher's Exact test. P<0.05 was considered statistically significant.Investigators hypothesized that the antiemetic efficacy of the aprepitant and dexamethasone combination is superior compared with ondansetron and dexamethasone combination following the laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group DA: Dexamethasone and aprepitant | Active comparator | Drug: Dexamethasone and aprepitantGroup DA: Dexamethasone: 8 mg (intravenous), Aprepitant: 40 mg (oral) |
| Group DO: Dexamethasone and ondansetron | Placebo comparator | Drug: Dexamethasone and ondansetronGroup DO: Dexamethasone: 8 mg (intravenous), Ondansetron: 4 mg (intravenous) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18 Years to 60 Years
- ASA (American Society of Anesthesiologist) physical status I or II
- Patients undergoing laparoscopic gynecologic surgery or laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Hypersensitivity or contraindication to the study medications,
- Antiemetic drug or steroid use within 24 hours before anesthesia,
- History of diabetes mellitus,
- History of motion sickness or postoperative nausea and vomiting,
- Pregnancy,
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 and aprepitant | Drug | Group DA: Dexamethasone and aprepitant |
| Dexamethasone and ondansetron | Drug | Group DO: Dexamethasone and ondansetron |
Primary outcome
Complete response
Time frame: One year
The primary outcome is complete response: A complete response is defined as no postoperative nausea (VRS≤3), retching or vomiting and no need for rescue antiemetic.
4 secondary outcomes
Nausea
Time frame: One year
Retching
Time frame: One year
Vomiting
Time frame: One year
Need of rescue antiemetic
Time frame: One year
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 27 Dec 2013.
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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 Phase 4 study testing Dexamethasone and aprepitant and Dexamethasone and ondansetron in people with Postoperative Nausea and Vomiting, run by Yeditepe University 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 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 27 Dec 2013. 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. 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.
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?
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?
Complete response (time frame: One year). 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 27 Dec 2013.