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Ondansetron vs Ondansetron Plus Dexamethasone for Relieving Intrathecal Morphine Side Effects After C-section

NCT02793843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2017-11-06

No results posted yet for this study

Summary

Background: Common adverse side effects related to the use of neuraxial opioids in the obstetric population include nausea, vomiting, and pruritus. Serotonin (5-HT3) receptor antagonists, in particular ondansetron, have been identified as possible antipruritic agents. It was reported that dexamethasone plus ondansetron is more effective than ondansetron for prevention of postoperative nausea and vomiting but no additional effect on treating pruritus.

Objectives: The purpose of this study is to compare the effect of prophylactic ondansetron versus ondansetron plus dexamethasone after cesarean section on pruritus and postoperative nausea and vomiting (PONV).

Methods: A prospective randomized double blind study that will be conducted between June 2016 and June 2017. Patients will be randomly allocated into two groups. The first group will receive 4 mg intravenous (IV) ondansetron while the other group will receive 4 mg IV ondansetron plus 8 mg dexamethasone.

Conditions

Interventions

DRUG

Ondansetron (Zofran)

Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia

DRUG

Dexamethasone (Decadron)

Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia

OTHER

Spinal anesthesia

Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)

Sponsors & Collaborators

  • Makassed General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-06-15
Completion
2017-07-30

Countries

  • Lebanon

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02793843 on ClinicalTrials.gov