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

Makassed General Hospital

Status: Completed

Conditions: Cesarean Section; Pruritus

Treatments: Drug: Ondansetron (Zofran); Drug: Dexamethasone (Decadron); Other: Spinal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT02793843

2432016

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 194 patients

Sex: Female

Ages: 19 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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194 participants in 2 patient groups

Ondansetron

Active Comparator group

Treatment:

Drug: Ondansetron (Zofran)

Other: Spinal anesthesia

Ondansetron+ dexamethasone

Experimental group

Treatment:

Drug: Dexamethasone (Decadron)

Drug: Ondansetron (Zofran)

Other: Spinal anesthesia