Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
Keywords
Abstract
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
1. Patient undergoes elective cesarean section age more than 18 years
2. Patient accepted in spinal anesthesia technique
3. ASA classification I-II
4. Patient understand question and evaluation process
Exclusion criteria
1. Hyperemesis gravidarum
2. Patient with ongoing antiemetic drugs treatment
3. 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
1. Nausea and vomiting score
2. Pain score
3. Sedation score
4. Itch symptom
5. Patient satisfaction
Dates
| Last Verified: | 04/30/2009 |
| First Submitted: | 05/02/2009 |
| Estimated Enrollment Submitted: | 05/02/2009 |
| First Posted: | 05/04/2009 |
| Last Update Submitted: | 05/02/2009 |
| Last Update Posted: | 05/04/2009 |
| Actual Study Start Date: | 04/30/2009 |
| Estimated Primary Completion Date: | 03/31/2010 |
| Estimated Study Completion Date: | 03/31/2011 |
Condition or disease
Intervention/treatment
Drug: 3
Drug: 4
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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: 3 Metoclopramide 10 mg and dexamethasone 5 mg intravenous |
| Active Comparator: 4 dexamethasone 5 mg and ondansetron 8 mg IV | Drug: 4 Ondansetron 8 mg and dexamethasone 5 mg IV |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section [24 hrs post operatively]
Secondary Outcome Measures
1. Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction [24 Hrs post operatively]
