Intravenous Ondansetron to Attenuate the Hypotensive, Bradycardic Response to Spinal Anesthesia in Healthy Parturients

NCT01414777 | Completed Phase 2

• 1 other identifier: 14583
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that given prophylactically, intravenous ondansetron will attenuate the drop in blood pressure and heart rate frequently seen after spinal anesthesia. Eighty-six American Society of Anesthesiologists (ASA) physical status I or II in preoperative patient assessment, parturients age of 18 to 45 years scheduled to undergo elective caesarean section will be enrolled. Patients will be randomized to 2 groups: the ondansetron group, receiving 8 mg intravenous ondansetron diluted in 10 mL of saline; or the placebo group, who were administered 10 mL of saline given 5 minutes prior to performing the spinal anesthetic. Investigational Pharmacy will randomize and dispense study drug. Baseline measurements of vital signs will be taken. Otherwise standard management will then be used:

• Patients must be NPO for 8 hours
• Pulse oximetry, EKG monitoring, noninvasive blood pressure at a minimum of every 3 minutes, more frequently if decided by the provider.
• Standard lumbar puncture in a sitting position the L3-L4 or L4-L5
• Whitacre pencil-point, 25 gauge
• Injectate: 2 mL of 0.75% hyperbaric bupivacaine, 100 mcg preservative free morphine, 20 mcg fentanyl
• Immediately after completing the subarachnoid injection, patients will be laid supine with left lateral uterine displacement The sensory level of anesthesia will be assessed in the standard fashion every five minutes using ice. The motor component will tested using the Bromage scale for spinal anesthesia (0, no paralysis; 1, inability to lift the thigh \[only knee/feet\]; 2, inability to flex the knee \[only feet\]; 3, inability to move any joint in the legs).

Conditions

Hypotension; Pregnancy

Keywords

c-section; Hypotension after spinal anesthesia for C-section

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability"

  hypotension \& bradycardia will be recorded from the placement of the spinal through the end of surgical c-section

  day 1

Secondary Outcomes (5)

• dosage of vasopressors administered

  day one

• number of episodes of nausea

  24 hours after surgery

• occurrence & intensity of itching

  24 hours after surgery

• pain scores reported by the patient

  24 hours after surgery

• dosage of anticholinergics administered

  24 hours after surgery

Study Arms (2)

ondansetron

EXPERIMENTAL

ondansetron 8 mg IV will be administered prior to placement of the spinal anesthesia

Drug: ondansetron

Placebo

PLACEBO COMPARATOR

Ondansetron 8 mg IV or Placebo will be administered prior to placement of the spinal anesthestic

Drug: placebo

Interventions

ondansetron DRUG

Ondansetron 8mg IV or placebo will be administered prior to placement of the spinal anesthetic

Also known as: epidural

ondansetron

placebo DRUG

placebo or ondansetron 8mg IV will be administered prior to placement of the spinal anesthetic

Also known as: epidural

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Elective Caesarean section
• Consent to be in the study
• Age 18-45
• ASA 1 or 2

You may not qualify if:

• Patient refusal
• Patients with known allergy to ondansetron will be excluded
• Contraindications to spinal anesthetic
• Known Coagulopathy (acquired e.g. anticoagulation or existing such as liver disease; using patient history, physical examination to determine bleeding risks, a platelet count under 100 or a PT INR over 1.4)
• Severely altered anatomy (e.g. post surgical changes)
• Existing neurological deficits (Women with a history of migraine or tension headache will be allowed to enroll. More severe conditions with daily life limiting symptoms will be excluded. Examples include epilepsy, pseudotumor cerebri, prior stroke with persistent neurologic deficits, or any motor or sensory neuropathy with existing deficits)
• Skin infection overlying site

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (31)

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MeSH Terms

Conditions

Hypotension

Interventions

Ondansetron; Injections, Epidural

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

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; Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jordan Hackworth, MD

  University of Virginia Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: August 11, 2011
• Study Start: November 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

US (1)