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

Pregnancy Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00892996
• Other study ID #: Si 9091/2552(EC2)
• Status: Active, not recruiting
• Phase: N/A
• First received: May 3, 2009
• Last updated: May 3, 2009
• Start date: May 2009
• Est. completion date: April 2011

Study information

• Verified date: May 2009
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 2011
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• PONV
• Postoperative Nausea and Vomiting
• Pregnancy
• Vomiting

Intervention

Drug:
• dexamethasone
Metoclopramide 10 mg and dexamethasone 5 mg intravenous
• dexamethasone 5 mg
Ondansetron 8 mg and dexamethasone 5 mg IV

Locations

Country	Name	City	State
Thailand	Anesthesiology department, Siriraj hospital, Mahidol University	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. Epub 2007 Feb 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nausea and vomiting after spinal anesthesia with intrathecal morphine in cesarean section		24 hrs post operatively	Yes
Secondary	Secondary outcome measurement 1. Sedation score 2. Pain score 3. Itching symptom 4. Patient satisfaction		24 Hrs post operatively	Yes