Effects of Ondansetron on Hemodynamics in Cesarean Section Under Spinal Anesthesia

NCT03629522 | Completed Phase 4

• 1 other identifier: C/SOP2018
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

BACKGROUND: Spinal anesthesia (SA) induced maternal hypotension is the most frequent and troublesome complication in cesarean section (CS), compromising both maternal and neonatal well-being. Many strategies have been used to prevent its occurrence but no single technique has been confirmed to be completely effective. the investigators hypothesized that ondansetron, a serotonin-receptor-antagonist, could have beneficial effects on maternal hemodynamics during CS under SA. METHODS: In this prospective double-blind placebo-controlled study, one hundred healthy parturients were randomized to receive either 8 mg of intravenous ondansetron (group O) or the same volume of saline (group S), 5 minutes prior to the induction of SA. All women received a coloading volume of 500 ml of saline. Maternal hemodynamics: blood pressure, heart rate and cardiac output (CO) were measured with a non-invasive device based on pulse wave transit time: the esCCO device Nihon Kohden hemodynamic monitor. Ephedrine was administered to treat hypotension (systolic blood pressure less than 80% of baseline).

Conditions

Ondansetron; Cesarean Section; Spinal Anesthesia; Hemodynamics

Outcome Measures

Primary Outcomes (1)

• hypotension

  decrease of systolic blood pressue with more than 25% from baseline values

  5 min after spinal anesthésia

Secondary Outcomes (2)

• escco

  5 min after spinal anesthésia

• ephedrine consumption

  during 2 hours of anesthetic time

Study Arms (2)

ondansetron group

ACTIVE COMPARATOR

Ondansetron 8Mg/4mL Injection: administration of a bolus of 8 mg intravenous Ondansetron diluted in 10 ml of saline solution (0,09%) 5 minutes before spinal anesthesia

Drug: Ondansetron 8Mg/4mL Injection

control group

PLACEBO COMPARATOR

administration of 10 ml of saline solution (0,09%) 5 minutes before spinal anesthesia

Drug: Ondansetron 8Mg/4mL Injection

Interventions

Ondansetron 8Mg/4mL Injection DRUG

investigators administrated intravenously Ondansetron 8 mg 5 minutes before spinal anesthesia.

Also known as: OD-C/S

control group; ondansetron group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parturients eligible for the present study are women who:
• are scheduled for elective cesarean section under spinal anesthesia
• aged between 20 to 40 years
• are with an American Society of Anesthesiologist (ASA) physical status of I-II
• are with a normal liver and renal function and fetal screening, and with no medical history of heart disease.
• are with a single fetus.

You may not qualify if:

• Refusal to participate.
• Contraindication to spinal anesthesia
• Age \<20 or \>40 years.
• Obesity (body mass index (BMI) at term \>35 kg/m2).
• History of hypersensitivity to study's drugs.
• History of long QT syndrome
• Hypertensive disorders of pregnancy.
• Women receiving selective serotonin reuptake inhibitors or migraine medications.
• Urgent cesarean section.
• Multiple pregnancies.
• Failure of spinal anesthesia.
• Conversion to general anesthesia.
• The occurrence of an anesthetic or surgical complication.

Sponsors & Collaborators

• University Hospital, Mahdia: lead

Study Sites (2)

Mahdia University Hospital

Mahdia, 5100, Tunisia

Location

Ministry of Health

Tunis, 1002, Tunisia

Location

MeSH Terms

Interventions

Ondansetron; Injections

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; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• bechir haddad, professor

  tunisian Ministry of Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: an anesthesia nurse ; not included in the analysis, verified the allocation and prepared the syringe fulled with ondansetron or saline solution
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Model Details: Ondansetron group (group O): 8mg(10 ml) of Ondansetron administrated 5 minutes before spinal anesthesia control group (group C): saline solution 0,9%(10ml)

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: August 14, 2018
• Study Start: August 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 30, 2017
• Last Updated: August 14, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)