We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00892996
Recruitment Status : Unknown
Verified May 2009 by Mahidol University.
Recruitment status was:  Active, not recruiting
First Posted : May 5, 2009
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:
Mahidol University

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
Pregnancy PONV Drug: dexamethasone Drug: dexamethasone 5 mg

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

Study Type : Interventional  (Clinical Trial)
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 2009
Estimated Primary Completion Date : April 2010
Estimated Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section [ Time Frame: 24 hrs post operatively ]

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Siriraj institutional review board, mahidol university
ClinicalTrials.gov Identifier: NCT00892996     History of Changes
Other Study ID Numbers: Si 9091/2552(EC2)
First Posted: May 5, 2009    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009

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

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Dexamethasone acetate
Dexamethasone
Ondansetron
Metoclopramide
Morphine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Central Nervous System Depressants