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Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section

NCT02036697 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-11-08

No results posted yet for this study

Summary

We propose to study the effects on hemodynamics (blood pressure, cardiac output, and central venous pressure) of two doses of bupivacaine for spinal anesthesia during cesarean section: a higher dose of 12 mg to a lower dose of 4.5 mg. We will examine recovery times, incidence of hypotension, and compare pain control and maternal satisfaction during and after cesarean section.

We hypothesize that low dose bupivacaine spinal anesthesia will provide equivalent anesthesia for cesarean section compared to conventional dose bupivacaine, with less hypotension, faster recovery time, and enhanced maternal satisfaction. Maternal satisfaction will be assessed by self-reported pain scores, incidence of nausea and vomiting, shivering, and ability to interact with baby in the OR.

Conditions

  • Complications; Cesarean Section
  • Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
  • Hemodynamic Instability
  • Personal Satisfaction

Interventions

DRUG

Bupivacaine 4.5

Bupivacaine hyperbaric, 4.5 mg

DRUG

Bupivacaine 9

Bupivacaine hyperbaric, 9 mg

DRUG

Morphine

morphine 150 mcg.

DRUG

Fentanyl

15 mcg

Sponsors & Collaborators

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Stephen E Kowalski, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-06-30
Completion
2015-12-31

Countries

  • Canada

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02036697 on ClinicalTrials.gov