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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Mahidol University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00892996
First received: May 3, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention
Pregnancy
PONV
Drug: dexamethasone
Drug: dexamethasone 5 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section [ Time Frame: 24 hrs post operatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction [ Time Frame: 24 Hrs post operatively ] [ Designated as safety issue: Yes ]

Enrollment: 120
Study Start Date: May 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Dexamo

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892996

Locations
Thailand
Anesthesiology department, Siriraj hospital, Mahidol University
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Patchareya Nivatpumin, M.D. Anesthesiology department, Siriraj hospital, Mahidol University
  More Information

Publications:
Responsible Party: Siriraj institutional review board, mahidol university
ClinicalTrials.gov Identifier: NCT00892996     History of Changes
Other Study ID Numbers: Si 9091/2552(EC2)
Study First Received: May 3, 2009
Last Updated: May 3, 2009
Health Authority: Thailand: Food and Drug Administration

Keywords provided by Mahidol University:
Intrathecal morphine
Cesarean section
Nausea and vomiting
Prevention

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Vomiting
Nausea
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Metoclopramide
Morphine
Ondansetron
Analgesics
Analgesics, Opioid
Anti-Anxiety Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Antipruritics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dermatologic Agents
Dopamine Agents
Dopamine Antagonists
Enzyme Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014