Postoperative NauseaPhase 2/3NCT03631004
Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
A Phase 2/3 study testing Olanzapine in people with Postoperative Nausea and Postoperative Nausea and Vomiting, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting. The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Nausea, Postoperative Nausea and Vomiting
- What is being tested?
- Olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2018to 10 Feb 2021
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia
- Patients aged between 18 and 60 years
- Patients considered to be at high risk for PONV according to the Apfel scale (Apfel 3 or 4)
- Patients with a history of chemotherapy-induced nausea and vomiting.
Who cannot join
- Pregnancy or Lactation
- Current use of typical anti-psychotic medications or atypical
- History of allergy to olanzapine
- Myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning
- History of severe ventricular arrhythmia (eg, VT or VF)
- Heart Failure Class II or greater second NYHA
Show all 15Show fewer
- Postural hypotension or vasovagal syncope in the 6 months prior to the day of surgery planning
- Narrow angle glaucoma
- Parkinson's disease
- Dementia
- Inability to swallow medicines
- QT interval history greater than 450ms or torsades de pointes
- Patient does not want to participate in the study
- Videolaparoscopy surgery
- Contraindication for neuraxial block
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Cancer Institute of the State of Sao Paulo - ICESP
São Paulo, São Paulo, 01403010
About this study
Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting.
The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.
Read the detailed description
Double blinded randomized clinical trial. Fifty patients will be selected for each group. Group A will receive 10mg olanzapine in the preoperative and group B will receive placebo in the preoperative period. Both groups will receive intravenous general anesthesia combined with epidural. All patients will receive epidural PCA.
The primary outcome of this study is the incidence of post-operative nausea and vomiting. The power of analysis was based on the following parameters: type error I (α = 0.05), error II (β = 0.8), 95% confidence interval and hypothesis test two-tailed. Thus, 42 patients are indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the population risk from 60% to 30%. The population will be composed of 100 patients because it is assumed that percentage of loss of 10% per group.
The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data.
For quantitative variables, the Student's t-test will be used for with normal distribution or Mann-Whitney for non-distributed data normal.
For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p, 0.05.
Data will be collected and managed using REDCap data capture tools
- Being tested
- Olanzapine
- Keywords
- nausea and vomiting
- Medical subject headings
- Postoperative Nausea and Vomiting, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlanzapineDrug
Also called Treatment
olanzapine 10 mg is given before surgery
| Study group | Role | What they receive |
|---|---|---|
| olanzapine tablets | Experimental | PATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY Receives: Drug: Olanzapine |
| Starch tablets | Placebo comparator | PATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative nausea and vomiting
nausea and vomiting/ retching (dichotomous variable)
Measured: 0-24 hours
Secondary outcomes (17)
incidence of side effects
side effects
Measured: 0-6 hours
incidence of side effects
side effects
Measured: 0-24 hours
incidence of side effects
side effects
Measured: 24-48 hours
incidence of postoperative nausea and vomiting
nausea and vomiting/ retching (dichotomous variable)
Measured: 0-6 hours
incidence of postoperative nausea and vomiting
nausea and vomiting/ retching (dichotomous variable)
Measured: 24-48 hours
incidence of postoperative nausea
nausea and vomiting/ retching (dichotomous variable)
Measured: 0-6 hours
incidence of postoperative nausea
nausea and vomiting/ retching (dichotomous variable)
Measured: 0-24 hours
incidence of postoperative nausea
nausea and vomiting/ retching (dichotomous variable)
Measured: 24-48 hours
incidence of postoperative vomiting/retching
vomiting/ retching (dichotomous variable)
Measured: 0-6 hours
incidence of postoperative vomiting/retching
vomiting/ retching (dichotomous variable)
Measured: 0-24 hours
incidence of postoperative vomiting/retching
vomiting/ retching (dichotomous variable)
Measured: 24-48 hours
incidence of severe PONV
This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important.
Measured: 0-6 hours
incidence of severe PONV
This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important.
Measured: 0-24 hours
incidence of severe PONV
This scale consists of four questions. Each question generates a different score. For the first question, if the patient vomited or retched three or more times, the final score was 50. Otherwise, the highest score from question 1 or question 2 was multiplied by the scores of question 3 and question 4, yielding the final value. When the score was ≥ 50, the symptom was considered clinically important.
Measured: 24-48 hours
incidence of nausea severity
mild, moderate, or severe
Measured: 0-6 hours
incidence of nausea severity
mild, moderate, or severe
Measured: 0-24 hours
incidence of nausea severity
mild, moderate, or severe
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start1 Oct 2018
- Primary completion10 Feb 2021
- Study completion10 Feb 2021
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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roger Chammas, Study director, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03631004
- Sponsor's protocol ID
- 1287/18
- Status last verified
- Dec 2021
- First submitted
- 11 Aug 2018
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- 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 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-operative Olanzapine as Prophylactic Antiemetic in Oncologic Patients
- ClinicalTrials.gov ID
- NCT03631004
- Acronym / sponsor ID
- 1287/18
- Keywords
- nausea and vomiting
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 15 Aug 2018 (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.
Olanzapine has been used as prophylactic antiemetic for chemotherapy induced nausea and vomiting.
The project aims to evaluate the efficacy of olanzapine in combination with ondansetron and dexamethasone in patients at high risk of postoperative nausea and vomiting, with previous history of nausea and vomiting induced by prior chemotherapy, submitted to medium and large surgery.
Detailed description
Double blinded randomized clinical trial. Fifty patients will be selected for each group. Group A will receive 10mg olanzapine in the preoperative and group B will receive placebo in the preoperative period. Both groups will receive intravenous general anesthesia combined with epidural. All patients will receive epidural PCA.
The primary outcome of this study is the incidence of post-operative nausea and vomiting. The power of analysis was based on the following parameters: type error I (α = 0.05), error II (β = 0.8), 95% confidence interval and hypothesis test two-tailed. Thus, 42 patients are indicated per group to obtain reduction of the incidence of nausea and / or vomiting of the population risk from 60% to 30%. The population will be composed of 100 patients because it is assumed that percentage of loss of 10% per group.
The statistical analysis will be performed in program R version 3.5.1. The results obtained will be presented as mean + standard deviation for continuous data or absolute frequency for described data.
For quantitative variables, the Student's t-test will be used for with normal distribution or Mann-Whitney for non-distributed data normal.
For qualitative variables, the chi-square test will be used or Fisher's exact test. Significant difference is defined as p, 0.05.
Data will be collected and managed using REDCap data capture tools
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olanzapine tablets | Experimental | Drug: OlanzapinePATIENT WILL TAKE OLANZAPINE 10 MG, 1 hour BEFORE SURGERY |
| Starch tablets | Placebo comparator | Drug: OlanzapinePATIENT WILL TAKE PLACEBO 1 hour BEFORE SURGERY |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients submitted to medium and large surgeries in the thoracic or abdominal region (mastectomies, breast plastic, hysterectomies, annexectomies, gynecological pelvic surgeries, colectomies, rettosigmoidectomies) under general anesthesia
- Patients aged between 18 and 60 years
- Patients considered to be at high risk for PONV according to the Apfel scale (Apfel 3 or 4)
- Patients with a history of chemotherapy-induced nausea and vomiting.
Key exclusion criteria (15 listed)
- Pregnancy or Lactation
- Current use of typical anti-psychotic medications or atypical
- History of allergy to olanzapine
- Myocardial infarction or unstable angina in the 6 months prior to the day of surgery planning
- History of severe ventricular arrhythmia (eg, VT or VF)
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 |
|---|---|---|
| OlanzapineAlso: Treatmentolanzapine 10 mg is given before surgery | Drug | Starch tablets, olanzapine tablets |
Primary outcome
incidence of postoperative nausea and vomiting
Time frame: 0-24 hours
nausea and vomiting/ retching (dichotomous variable)
17 secondary outcomes
incidence of side effects
Time frame: 0-6 hours
incidence of side effects
Time frame: 0-24 hours
incidence of side effects
Time frame: 24-48 hours
incidence of postoperative nausea and vomiting
Time frame: 0-6 hours
incidence of postoperative nausea and vomiting
Time frame: 24-48 hours
incidence of postoperative nausea
Time frame: 0-6 hours
incidence of postoperative nausea
Time frame: 0-24 hours
incidence of postoperative nausea
Time frame: 24-48 hours
incidence of postoperative vomiting/retching
Time frame: 0-6 hours
incidence of postoperative vomiting/retching
Time frame: 0-24 hours
incidence of postoperative vomiting/retching
Time frame: 24-48 hours
incidence of severe PONV
Time frame: 0-6 hours
incidence of severe PONV
Time frame: 0-24 hours
incidence of severe PONV
Time frame: 24-48 hours
incidence of nausea severity
Time frame: 0-6 hours
incidence of nausea severity
Time frame: 0-24 hours
incidence of nausea severity
Time frame: 24-48 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 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Postoperative Nausea
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
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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.
Roger Chammas study director
Instituto do Cancer do Estado de São Paulo
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 Olanzapine in people with Postoperative Nausea and Postoperative Nausea and Vomiting, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 15 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 Jan 2022. 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 Brazil. 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 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: 0-24 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 Jan 2022.