PregnancyNCT00892996
Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
A study testing dexamethasone and dexamethasone 5 mg in people with Pregnancy and PONV, run by Mahidol University at 1 site in Thailand.
Trial summary
Post-operative nausea and vomiting are the major complications after spinal anesthesia with intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction of anesthesia to prevent these complication. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- dexamethasone and dexamethasone 5 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- May 2009to Apr 2011
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnancy patients undergo Elective cesarean section age more than 18 years
- Patient accept spinal anesthesia technique
- ASA classification I-II
- Patient understand question and evaluation process
Who cannot join
- Hyperemesis gravidarum
- Patient ongoing treatment with antiemetic drugs
- Allergy to Metoclopramide,Ondansetron and Dexamethasone
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, Bangkok, 10700
About this study
Official title: Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section: a Randomized Comparison of Metoclopramide or Ondansetron Alone or in the Combination With Dexamethasone.
Post-operative nausea and vomiting are the major complications after spinal anesthesia with intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction of anesthesia to prevent these complication.
Furthermore, administration of a combination of antiemetic drugs with different mechanisms of action appears reasonable and synergistic effect of drugs.
In conclusion, we study efficacy of antiemetic effect of single antiemetic drug compare with combination antiemetic drugs.
Read the detailed description
In this study : a randomized, double-blind, placebo-controlled, clinical trial comparing single doses of Metoclopramide 10 mg and Ondansetron 8 mg alone and a combination of Dexamethasone 5 mg and Metoclopramide 10 mg or a combination of Dexamethasone 5 mg and Ondansetron 8 mg for prevention of PONV after spinal morphine for cesarean section.
Inclusion criteria
- Patient undergoes elective cesarean section age more than 18 years
- Patient accepted in spinal anesthesia technique
- ASA classification I-II
- Patient understand question and evaluation process
Exclusion criteria
- Hyperemesis gravidarum
- Patient with ongoing antiemetic drugs treatment
- Patient with history of drug allergy in Metoclopramide,Ondansetron and Dexamethasone
Outcome measurement By oral interview and nurse notification in 24 hr. post-operatively.
Detail of outcome measurement
- Nausea and vomiting score
- Pain score
- Sedation score
- Itch symptom
- Patient satisfaction
- Being tested
- dexamethasone, dexamethasone 5 mg
- Keywords
- Intrathecal morphine, Cesarean section, Nausea and vomiting, Prevention
- 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.
dexamethasoneDrug
Also called Dexamo
Metoclopramide 10 mg and dexamethasone 5 mg intravenous
dexamethasone 5 mgDrug
Also called Dexamo
Ondansetron 8 mg and dexamethasone 5 mg IV
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Metoclopramide 10 mg intravenous |
| 2 | No intervention | Ondansetron 8 mg intravenous |
| 3 | Active comparator | dexamethasone 5 mg and metoclopramide 10 mg Receives: Drug: dexamethasone |
| 4 | Active comparator | dexamethasone 5 mg and ondansetron 8 mg IV Receives: Drug: dexamethasone 5 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section
Measured: 24 hrs post operatively
Secondary outcomes (1)
Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction
Measured: 24 Hrs post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2009 (estimated)
- Study startMay 2009
- Primary completionApr 2010 (estimated)
- Study completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Patchareya Nivatpumin, M.D., Principal investigator, Anesthesiology department, Siriraj hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892996
- Sponsor's protocol ID
- Si 9091/2552(EC2)
- Status last verified
- May 2009
- First submitted
- 3 May 2009
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wu JI, Lo Y, Chia YY, Liu K, Fong WP, Yang LC, Tan PH. Prevention of postoperative nausea and vomiting after intrathecal morphine for Cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination. Int J Obstet Anesth. 2007 Apr;16(2):122-7. doi: 10.1016/j.ijoa.2006.11.004. Epub 2007 Feb 1.
PubMed 17275282Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
PubMed 34002866
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section: a Randomized Comparison of Metoclopramide or Ondansetron Alone or in the Combination With Dexamethasone.
- ClinicalTrials.gov ID
- NCT00892996
- Acronym / sponsor ID
- Si 9091/2552(EC2)
- Keywords
- Intrathecal morphine, Cesarean section, Nausea and vomiting, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Apr 2011 (estimated)
- First posted
- 5 May 2009 (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.
Post-operative nausea and vomiting are the major complications after spinal anesthesia with intrathecal morphine, therefore antiemetic drugs should be administered for best satisfaction of anesthesia to prevent these complication.
Furthermore, administration of a combination of antiemetic drugs with different mechanisms of action appears reasonable and synergistic effect of drugs.
In conclusion, we study efficacy of antiemetic effect of single antiemetic drug compare with combination antiemetic drugs.
Detailed description
In this study : a randomized, double-blind, placebo-controlled, clinical trial comparing single doses of Metoclopramide 10 mg and Ondansetron 8 mg alone and a combination of Dexamethasone 5 mg and Metoclopramide 10 mg or a combination of Dexamethasone 5 mg and Ondansetron 8 mg for prevention of PONV after spinal morphine for cesarean section.
Inclusion criteria
- Patient undergoes elective cesarean section age more than 18 years
- Patient accepted in spinal anesthesia technique
- ASA classification I-II
- Patient understand question and evaluation process
Exclusion criteria
- Hyperemesis gravidarum
- Patient with ongoing antiemetic drugs treatment
- Patient with history of drug allergy in Metoclopramide,Ondansetron and Dexamethasone
Outcome measurement By oral interview and nurse notification in 24 hr. post-operatively.
Detail of outcome measurement
- Nausea and vomiting score
- Pain score
- Sedation score
- Itch symptom
- Patient satisfaction
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Metoclopramide 10 mg intravenous |
| 2 | No intervention | –Ondansetron 8 mg intravenous |
| 3 | Active comparator | Drug: dexamethasonedexamethasone 5 mg and metoclopramide 10 mg |
| 4 | Active comparator | Drug: dexamethasone 5 mgdexamethasone 5 mg and ondansetron 8 mg IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnancy patients undergo Elective cesarean section age more than 18 years
- Patient accept spinal anesthesia technique
- ASA classification I-II
- Patient understand question and evaluation process
Key exclusion criteria (3 listed)
- Hyperemesis gravidarum
- Patient ongoing treatment with antiemetic drugs
- Allergy to Metoclopramide,Ondansetron and Dexamethasone
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: DexamoMetoclopramide 10 mg and dexamethasone 5 mg intravenous | Drug | 3 |
| dexamethasone 5 mgAlso: DexamoOndansetron 8 mg and dexamethasone 5 mg IV | Drug | 4 |
Primary outcome
nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section
Time frame: 24 hrs post operatively
1 secondary outcome
Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction
Time frame: 24 Hrs post operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2009.
- Background: PubMed 17275282Wu JI, Lo Y, Chia YY, Liu K, Fong WP, Yang LC, Tan PH. Prevention of postoperative nausea and vomiting after intrathecal morphine for Cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination. Int J Obstet Anesth. 2007 Apr;16(2):122-7. doi: 10.1016/j.ijoa.2006.11.004. Epub 2007 Feb 1.
- Derived from this study: PubMed 34002866Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
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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.
Patchareya Nivatpumin, M.D. principal investigator
Anesthesiology department, Siriraj hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dexamethasone and dexamethasone 5 mg in people with Pregnancy and PONV, run by Mahidol University at 1 site in Thailand.
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 3 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: status not confirmed, as of the sponsor's last update on 5 May 2009. 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 Thailand. 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?
Results are not available in the source record.
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 vomiting after spinal anesthesia with intrathecal morphine in cesarean section (time frame: 24 hrs post operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00892996, which also lists 2 linked publications.
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 5 May 2009.