NCT00892996

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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. 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 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

Conditions

• Pregnancy
• PONV

Interventions

Type	Name	Description
DRUG	dexamethasone	Metoclopramide 10 mg and dexamethasone 5 mg intravenous
DRUG	dexamethasone 5 mg	Ondansetron 8 mg and dexamethasone 5 mg IV

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-04-01
• Completion: 2011-04-01
• First posted: 2009-05-05
• Last updated: 2009-05-05

Locations

1 site across 1 country: Thailand