Hemodynamic Protection of Preoperative Ondansetron 15 Minutes Before Spinal Anaesthesia in Caesarean Section

NCT04140058 | Completed Phase 3

• 1 other identifier: 2433/2016/10
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anaesthesia for caesarean section is the most commonly used anaesthetic choice in caesarean deliveries. This is usually associated with maternal hypotension and other adverse side effects. Prophylactic intravenous administration of ondansetron immediately and 5 minutes preoperatively have shown to provide a protective effect against hypotension while other studies have shown little effect on the incidence of blood pressure drop in healthy parturients. The investigators will study the effect of different doses and timing of intravenous ondansetron in full term obstetric patients undergoing elective lower segment caesarean section under spinal anaesthesia on the incidence and severity of hypotension and other adverse side effects in healthy parturients having the standard intrathecal plain bupivacaine and fentanyl.

Conditions

Hypotension; Nausea; Vomiting

Keywords

Ondansetron; hypotension; nausea and vomiting; cesarean section

Outcome Measures

Primary Outcomes (1)

• Usage of Ondansetron prophylactically to prevent a significant decrease in systolic, diastolic, and mean blood pressure after the induction of spinal anaesthesia.

  Baseline values of Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), and Mean Blood Pressure (MBP) were recorded. Ondansetron was given 15 minutes before induction of spinal anesthesia. After initiation of spinal anesthesia, the SBP, DBP, and MBP were recorded regularly until the end of the cesarean section by a blinded anaesthesiologist.

  1 year

Secondary Outcomes (1)

• Prevention of intraoperative nausea and vomiting.

  1 year

Study Arms (3)

group O4

ACTIVE COMPARATOR

Patients received 4mg ondansetron.

Drug: Ondansetron

group O6

ACTIVE COMPARATOR

Patients received 6mg ondansetron.

Drug: Ondansetron

group C

PLACEBO COMPARATOR

Patients received normal saline.

Drug: Normal saline

Interventions

Ondansetron DRUG

ondansetron was administered 20 minutes prior to spinal anesthesia.

group O4; group O6

Normal saline DRUG

Placebo of 10 mL normal saline was administered.

group C

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: full-term pregnant females undergoing cesarean section.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients who received spinal anesthesia for elective cesarean sections and meet the American Society of Anesthesiologist's (ASA) patient status classification I or II.

You may not qualify if:

• Patients ASA patient status classification III, IV or V
• Emergent cesarean sections
• Multiple parities (twins/triplets)
• More than 1,000 ml blood loss
• More than 6 mg ondansetron administered
• Patients presenting with a cardiac history (coronary artery disease, myocardial infarction, congestive heart failure, murmur, mitral valve prolapse/regurgitation, dysrhythmias, aortic stenosis/regurgitation)
• Patients presenting with preeclampsia
• Patients presenting for cesarean section with epidural due to failure to progress.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

Jordan University Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Hypotension; Nausea; Vomiting

Interventions

Ondansetron; Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Anesthesia and Intensive care

Study Record Dates

• First Submitted: October 13, 2019
• First Posted: October 25, 2019
• Study Start: January 2, 2016
• Primary Completion: January 2, 2017
• Study Completion: January 2, 2017
• Last Updated: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)