NCT00892996

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

May 5, 2009

Status Verified

May 1, 2009

Enrollment Period

11 months

First QC Date

May 3, 2009

Last Update Submit

May 3, 2009

Conditions

PregnancyPONV

Keywords

Intrathecal morphineCesarean sectionNausea and vomitingPrevention

Outcome Measures

Primary Outcomes (1)

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

    24 hrs post operatively

Secondary Outcomes (1)

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

    24 Hrs post operatively

Study Arms (4)

1

NO INTERVENTION

Metoclopramide 10 mg intravenous

2

NO INTERVENTION

Ondansetron 8 mg intravenous

3

ACTIVE COMPARATOR

dexamethasone 5 mg and metoclopramide 10 mg

Drug: dexamethasone

4

ACTIVE COMPARATOR

dexamethasone 5 mg and ondansetron 8 mg IV

Drug: dexamethasone 5 mg

Interventions

dexamethasoneDRUG

Metoclopramide 10 mg and dexamethasone 5 mg intravenous

Also known as: Dexamo
3
dexamethasone 5 mgDRUG

Ondansetron 8 mg and dexamethasone 5 mg IV

Also known as: Dexamo
4

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Hyperemesis gravidarum
  • Patient ongoing treatment with antiemetic drugs
  • Allergy to Metoclopramide,Ondansetron and Dexamethasone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology department, Siriraj hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 17275282BACKGROUND

  • 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.

    PMID: 34002866DERIVED

MeSH Terms

Conditions

Postoperative Nausea and VomitingNauseaVomiting

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Patchareya Nivatpumin, M.D.

    Anesthesiology department, Siriraj hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2009

First Posted

May 5, 2009

Study Start

May 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2011

Last Updated

May 5, 2009

Record last verified: 2009-05

Locations

TH(1)