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

Cesarean Section Clinical Trial

Official title:

A Randomized Study Evaluating Preventive Role of Ondansetron Versus Ondansetron Plus Dexamethasone for Postoperative Side Effects of Intrathecal Morphine Injection in Patients Undergoing Elective C-section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02793843
• Other study ID #: 2432016
• Status: Completed
• Phase: N/A
• First received: June 3, 2016
• Last updated: November 2, 2017
• Start date: June 2016
• Est. completion date: July 30, 2017

Study information

• Verified date: November 2017
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: July 30, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Pruritus

Intervention

Drug:
• Ondansetron (Zofran)
Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia
• 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)

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pruritus assessed through questionnaire		24 hours postoperatively
Secondary	Post operative nausea and vomiting assessed through questionnaire		24 hours postoperatively