Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section
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|ClinicalTrials.gov Identifier: NCT02036697|
Recruitment Status : Terminated (Difficulty with patient recruitment.)
First Posted : January 15, 2014
Last Update Posted : November 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Complications; Cesarean Section Effects of; Anesthesia, Spinal and Epidural, in Pregnancy Hemodynamic Instability Personal Satisfaction||Drug: Bupivacaine 4.5 Drug: Bupivacaine 9 Drug: Morphine Drug: Fentanyl||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||December 2015|
Experimental: Low Dose Spinal
Hyperbaric bupivacaine 4.5mg with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be positioned right side down and head down 20-30 degrees for the dural puncture and then positioned supine in the left lateral tilt position after the anesthetic solution has been given. The OR table will be kept in 20-30 degrees head down for the cesarean section.
Drug: Bupivacaine 4.5
Bupivacaine hyperbaric, 4.5 mg
morphine 150 mcg.
Active Comparator: Control Spinal Group
Hyperbaric bupivacaine 1.2cc (9mg) with fentanyl 15mcg and preservative free morphine 150mcg.
The patient will be in the sitting position for the dural puncture and then positioned supine, in the left lateral tilt position after the anesthetic solution has been given. Once block height has been established the patient will be placed in 20-30 degrees trendelenberg for the cesarean section.
Drug: Bupivacaine 9
Bupivacaine hyperbaric, 9 mg
morphine 150 mcg.
- Recovery room length of stay [ Time Frame: Current recovery room average length of stay is 4 hours ]The primary endpoint is the expected reduction in the Recovery Room length of stay. Based on a predicted 50-100% reduction in length of stay, alpha 0.05, power of 80%, and given an anticipated drop-out rate of 10%, a sample size of n = 20 study patients per group is required.
- Hemodynamics [ Time Frame: Average duration of surgery is 100 minutes ]Intraoperative management during Cesarean section, Hemodynamics (BP, HR, Cardiac Index)
- Maternal satisfaction scores [ Time Frame: Average duration of recovery room stay is 4 hours. ]Post-operative maternal satisfaction scores, every 30 minutes until the patient is discharge ready from PACU.
- Bromage Scores [ Time Frame: Average recovery room length of stay is 4 hours ]Bromage Scores every 30 minutes until discharge from PACU.
- Sensory Levels [ Time Frame: Average recovery room length of stay is 4 hours ]Sensory levels will be measured every 30 minutes until discharge from PACU.
- Remifentanil PCA [ Time Frame: Intra-operatively. Average OR Time is 100 minutes. ]Total Remifentanil PCA dose will be recorded intraoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036697
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3E 0W2|
|Principal Investigator:||Stephen E Kowalski, MD||University of Manitoba|