Postoperative NauseaPhase 1/2NCT04718727
Olanzapine for the Prevention of Postoperative Nausea and Vomiting
A Phase 1/2 study testing 5 mg Olanzapine Tablets and 10 mg Olanzapine Tablets in people with Postoperative Nausea, run by Amani Hassan Abdel-Wahab at 2 sites in Egypt.
Trial summary
Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Postoperative Nausea
- What is being tested?
- 5 mg Olanzapine Tablets and 10 mg Olanzapine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Mar 2021to 1 Feb 2023
- Phase
- Phase 1/2
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I and II patients
- undergoing ambulatory laparoscopic gynecologic surgery with general anesthesia
- patients have at least two of the four Apfel risk factors for PONV2
- Lack of history of psychiatric and psychotic illnesses.
Who cannot join
- ASA III and ≥ IV patients
- Psychological diseases
- History of chemotherapy
- have a pre-existing vestibular disorder or history of dizziness or preexisting nausea or vomiting in the 24 h before surgery, or were being treated with regular antiemetic therapy including systemic corticosteroids.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Assiut university hospitals
Asyut, Assiut Governorate, Egypt, 715715
Assiut university
Asyut
About this study
Official title: Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial
Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug.
Read the detailed description
Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention of Postoperative Nausea and Vomiting
- Conditions
- Postoperative Nausea
- Being tested
- Placebo, 5 mg Olanzapine Tablets, 10 mg Olanzapine Tablets
- 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.
PlaceboDrug
oral Placebo tablets one-hour preoperatively
5 mg Olanzapine TabletsDrug
Also called zyprexa
oral 5 mg Olanzapine tablets one-hour preoperatively
10 mg Olanzapine TabletsDrug
Also called zyprexa
oral 10 mg Olanzapine tablets one-hour preoperatively
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | patients will receive oral placebo tablets one hour preoperatively Receives: Drug: Placebo |
| Group 2 | Active comparator | patients will receive oral 5 mg Olanzapine tablets one hour preoperatively Receives: Drug: 5 mg Olanzapine Tablets |
| Group 3 | Active comparator | patients will receive oral 10 mg Olanzapine tablets one hour preoperatively Receives: Drug: 10 mg Olanzapine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
nausea and/or vomiting score
the occurrence of nausea and/or vomiting by nausea score
Measured: first 24 hours postoperative
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 start15 Mar 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative NauseaStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amani Hassan Abdel-Wahab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amani Hassan Abdel-Wahab, Assiut University
- Investigators
- Amani H Abdel-wahab, MD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718727
- Sponsor's protocol ID
- IRB: 17300536
- Status last verified
- Mar 2023
- First submitted
- 17 Jan 2021
- Last updated
- 9 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Olanzapine for the Prevention of Postoperative Nausea and Vomiting After Laparoscopic Surgery in High-risk Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04718727
- Acronym / sponsor ID
- IRB: 17300536
- Conditions
- Postoperative Nausea
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Amani Hassan Abdel-WahabUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- 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.
Nausea and vomiting (PONV) remain a common problem in surgical units. Even after two or three prophylactic antiemetic interventions, patients with all four of the Apfel risk factors for PONV have an estimated 30 to 40% chance of suffering PONV. Olanzapine as an antiemetic represents a new use of an antipsychotic drug.
Detailed description
Aim of the Research, to compare the effects of oral 10 and 5 mg Olanzapine for the Prevention of Postoperative Nausea and Vomiting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- All patients will receive oral 10, 5 mg Olanzapine or placebo one hour preoperative
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Drug: Placebopatients will receive oral placebo tablets one hour preoperatively |
| Group 2 | Active comparator | Drug: 5 mg Olanzapine Tabletspatients will receive oral 5 mg Olanzapine tablets one hour preoperatively |
| Group 3 | Active comparator | Drug: 10 mg Olanzapine Tabletspatients will receive oral 10 mg Olanzapine tablets one hour preoperatively |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I and II patients
- undergoing ambulatory laparoscopic gynecologic surgery with general anesthesia
- patients have at least two of the four Apfel risk factors for PONV2
- Lack of history of psychiatric and psychotic illnesses.
Key exclusion criteria (4 listed)
- ASA III and ≥ IV patients
- Psychological diseases
- History of chemotherapy
- have a pre-existing vestibular disorder or history of dizziness or preexisting nausea or vomiting in the 24 h before surgery, or were being treated with regular antiemetic therapy including systemic corticosteroids.
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 |
|---|---|---|
| Placebooral Placebo tablets one-hour preoperatively | Drug | Group 1 |
| 5 mg Olanzapine TabletsAlso: zyprexaoral 5 mg Olanzapine tablets one-hour preoperatively | Drug | Group 2 |
| 10 mg Olanzapine TabletsAlso: zyprexaoral 10 mg Olanzapine tablets one-hour preoperatively | Drug | Group 3 |
Primary outcome
nausea and/or vomiting score
Time frame: first 24 hours postoperative
the occurrence of nausea and/or vomiting by nausea score
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 9 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
Amani H Abdel-wahab, MD principal investigator
Assiut University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 5 mg Olanzapine Tablets and 10 mg Olanzapine Tablets in people with Postoperative Nausea, run by Amani Hassan Abdel-Wahab at 2 sites 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 4 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 9 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
nausea and/or vomiting score (time frame: first 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 9 Mar 2023.