Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Pregnancy, PONV

Intervention / Treatment
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* Drug: dexamethasone
* Drug: dexamethasone 5 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Metoclopramide 10 mg intravenous | |
| No Intervention: 2<br>Ondansetron 8 mg intravenous | |
| Active Comparator: 3<br>dexamethasone 5 mg and metoclopramide 10 mg | Drug: dexamethasone<br>* Metoclopramide 10 mg and dexamethasone 5 mg intravenous<br>* Other names: Dexamo;|
| Active Comparator: 4<br>dexamethasone 5 mg and ondansetron 8 mg IV | Drug: dexamethasone 5 mg<br>* Ondansetron 8 mg and dexamethasone 5 mg IV<br>* Other names: Dexamo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section |  | 24 hrs post operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction |  | 24 Hrs post operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrathecal morphine, Cesarean section, Nausea and vomiting, Prevention