Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
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|ClinicalTrials.gov Identifier: NCT00892996|
Recruitment Status : Unknown
Verified May 2009 by Mahidol University.
Recruitment status was: Active, not recruiting
First Posted : May 5, 2009
Last Update Posted : May 5, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy PONV||Drug: dexamethasone Drug: dexamethasone 5 mg||Not Applicable|
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.
- 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
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||May 2009|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||April 2011|
No Intervention: 1
Metoclopramide 10 mg intravenous
No Intervention: 2
Ondansetron 8 mg intravenous
Active Comparator: 3
dexamethasone 5 mg and metoclopramide 10 mg
Metoclopramide 10 mg and dexamethasone 5 mg intravenous
Other Name: Dexamo
Active Comparator: 4
dexamethasone 5 mg and ondansetron 8 mg IV
Drug: dexamethasone 5 mg
Ondansetron 8 mg and dexamethasone 5 mg IV
Other Name: Dexamo
- nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section [ Time Frame: 24 hrs post operatively ]
- Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction [ Time Frame: 24 Hrs post operatively ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00892996
|Anesthesiology department, Siriraj hospital, Mahidol University|
|Bangkok, Thailand, 10700|
|Principal Investigator:||Patchareya Nivatpumin, M.D.||Anesthesiology department, Siriraj hospital, Mahidol University|