Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention |
|---|---|
|
Pregnancy PONV |
Drug: dexamethasone Drug: dexamethasone 5 mg |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| 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. |
- nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section [ Time Frame: 24 hrs post operatively ] [ Designated as safety issue: Yes ]
- Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction [ Time Frame: 24 Hrs post operatively ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Metoclopramide 10 mg intravenous
|
|
|
No Intervention: 2
Ondansetron 8 mg intravenous
|
|
|
Active Comparator: 3
dexamethasone 5 mg and metoclopramide 10 mg
|
Drug: dexamethasone
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
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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
Exclusion criteria:
- Hyperemesis gravidarum
- Patient ongoing treatment with antiemetic drugs
- Allergy to Metoclopramide,Ondansetron and Dexamethasone
Contacts and Locations| Thailand | |
| Anesthesiology department, Siriraj hospital, Mahidol University | |
| Bangkok, Thailand, 10700 | |
| Principal Investigator: | Patchareya Nivatpumin, M.D. | Anesthesiology department, Siriraj hospital, Mahidol University |
More Information
Publications:
| Responsible Party: | Siriraj institutional review board, mahidol university |
| ClinicalTrials.gov Identifier: | NCT00892996 History of Changes |
| Other Study ID Numbers: | Si 9091/2552(EC2) |
| Study First Received: | May 3, 2009 |
| Last Updated: | May 3, 2009 |
| Health Authority: | Thailand: Food and Drug Administration |
Keywords provided by Mahidol University:
|
Intrathecal morphine Cesarean section Nausea and vomiting Prevention |
Additional relevant MeSH terms:
|
Nausea Vomiting Postoperative Nausea and Vomiting Signs and Symptoms, Digestive Signs and Symptoms Postoperative Complications Pathologic Processes Dexamethasone acetate Dexamethasone Metoclopramide Ondansetron Dexamethasone 21-phosphate Morphine BB 1101 Anti-Inflammatory Agents |
Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013