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

Primary Purpose

Pregnancy, PONV

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
dexamethasone
dexamethasone 5 mg
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Intrathecal morphine, Cesarean section, Nausea and vomiting, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Anesthesiology department, Siriraj hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Active Comparator

Active Comparator

Arm Label

1

2

3

4

Arm Description

Metoclopramide 10 mg intravenous

Ondansetron 8 mg intravenous

dexamethasone 5 mg and metoclopramide 10 mg

dexamethasone 5 mg and ondansetron 8 mg IV

Outcomes

Primary Outcome Measures

nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section

Secondary Outcome Measures

Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction

Full Information

First Posted
May 3, 2009
Last Updated
May 3, 2009
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT00892996
Brief Title
Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section
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 Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
April 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, PONV
Keywords
Intrathecal morphine, Cesarean section, Nausea and vomiting, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Metoclopramide 10 mg intravenous
Arm Title
2
Arm Type
No Intervention
Arm Description
Ondansetron 8 mg intravenous
Arm Title
3
Arm Type
Active Comparator
Arm Description
dexamethasone 5 mg and metoclopramide 10 mg
Arm Title
4
Arm Type
Active Comparator
Arm Description
dexamethasone 5 mg and ondansetron 8 mg IV
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Other Intervention Name(s)
Dexamo
Intervention Description
Metoclopramide 10 mg and dexamethasone 5 mg intravenous
Intervention Type
Drug
Intervention Name(s)
dexamethasone 5 mg
Other Intervention Name(s)
Dexamo
Intervention Description
Ondansetron 8 mg and dexamethasone 5 mg IV
Primary Outcome Measure Information:
Title
nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section
Time Frame
24 hrs post operatively
Secondary Outcome Measure Information:
Title
Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction
Time Frame
24 Hrs post operatively

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patchareya Nivatpumin, M.D.
Organizational Affiliation
Anesthesiology department, Siriraj hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anesthesiology department, Siriraj hospital, Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
17275282
Citation
Wu JI, Lo Y, Chia YY, Liu K, Fong WP, Yang LC, Tan PH. Prevention of postoperative nausea and vomiting after intrathecal morphine for Cesarean section: a randomized comparison of dexamethasone, droperidol, and a combination. Int J Obstet Anesth. 2007 Apr;16(2):122-7. doi: 10.1016/j.ijoa.2006.11.004. Epub 2007 Feb 1.
Results Reference
background
PubMed Identifier
34002866
Citation
Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.
Results Reference
derived

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

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