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

Sponsor

Mahidol University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00892996

Collaborator

(none)

120

Enrollment

Location

Arms

Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy PONV	Drug: dexamethasone Drug: dexamethasone 5 mg	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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.

Study Start Date :

May 1, 2009

Anticipated Primary Completion Date :

Apr 1, 2010

Anticipated Study Completion Date :

Apr 1, 2011

Arms and Interventions

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: dexamethasone Metoclopramide 10 mg and dexamethasone 5 mg intravenous Other Names: 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 Names: Dexamo