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

NCT ID: NCT02793843

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-07-30

Brief Summary

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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.

Detailed Description

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A prospective randomized double blind study will be conducted between June 2016 and June 2017. The sealed envelope technique will be used to randomly allocate females scheduled for elective cesarean section into two groups. After obtaining informed consent, all eligible patients will receive spinal anesthesia. The first group will receive 4 mg intravenous (IV) ondansetron with 2 ml saline while the other group will receive 4 mg IV ondansetron plus 8 mg (2 ml) dexamethasone.

Conditions

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Pruritus Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ondansetron

Group Type ACTIVE_COMPARATOR

Ondansetron (Zofran)

Intervention Type DRUG

Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia

Spinal anesthesia

Intervention Type OTHER

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

Ondansetron+ dexamethasone

Group Type EXPERIMENTAL

Ondansetron (Zofran)

Intervention Type DRUG

Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia

Dexamethasone (Decadron)

Intervention Type DRUG

Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia

Spinal anesthesia

Intervention Type OTHER

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

Interventions

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Ondansetron (Zofran)

Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia

Intervention Type DRUG

Dexamethasone (Decadron)

Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia

Intervention Type DRUG

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)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiology physical status 1 and 2
* Scheduled for elective c-section surgery under spinal anesthesia

Exclusion Criteria

* Patients with cardiac and psychological problems
* Patients who take sedatives or narcotics
* Patient who have allergy to study drugs
Minimum Eligible Age

19 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Makassed General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zoher Naja

Chairperson of Anesthesia and Pain Management Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Makassed General Hospital

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Other Identifiers

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2432016

Identifier Type: -

Identifier Source: org_study_id