Overview

This trial is active, not recruiting.

Conditions pregnancy, ponv
Treatments dexamethasone, dexamethasone 5 mg
Sponsor Mahidol University
Start date May 2009
End date April 2010
Trial size 120 participants
Trial identifier NCT00892996, Si 9091/2552(EC2)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(No Intervention)
Metoclopramide 10 mg intravenous
(No Intervention)
Ondansetron 8 mg intravenous
(Active Comparator)
dexamethasone 5 mg and metoclopramide 10 mg
dexamethasone Dexamo
Metoclopramide 10 mg and dexamethasone 5 mg intravenous
(Active Comparator)
dexamethasone 5 mg and ondansetron 8 mg IV
dexamethasone 5 mg Dexamo
Ondansetron 8 mg and dexamethasone 5 mg IV

Primary Outcomes

Measure
nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section
time frame: 24 hrs post operatively

Secondary Outcomes

Measure
Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction
time frame: 24 Hrs post operatively

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

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.
Principal investigator Patchareya Nivatpumin, M.D.
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
Trial information was received from ClinicalTrials.gov and was last updated in May 2009.
Information provided to ClinicalTrials.gov by Mahidol University.