Hemodynamic Instability Clinical Trial
Official title:
Hemodynamic Effects of Low Dose Spinal Anesthesia for Cesarean Section
Verified date | May 2016 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 30 |
Est. completion date | December 2015 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Adult females having elective, repeat cesarean sections who have given informed consent. Exclusion Criteria: - • Contraindications to dural puncture - BMI >40 - Elective C/S presenting in labour or with rupture of membranes - Placenta previa or accrete |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor)
Country | Name | City | State |
---|---|---|---|
Canada | Health Sciences Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Maternal satisfaction scores | Post-operative maternal satisfaction scores, every 30 minutes until the patient is discharge ready from PACU. | Average duration of recovery room stay is 4 hours. | No |
Other | Bromage Scores | Bromage Scores every 30 minutes until discharge from PACU. | Average recovery room length of stay is 4 hours | No |
Other | Sensory Levels | Sensory levels will be measured every 30 minutes until discharge from PACU. | Average recovery room length of stay is 4 hours | No |
Other | Remifentanil PCA | Total Remifentanil PCA dose will be recorded intraoperatively. | Intra-operatively. Average OR Time is 100 minutes. | No |
Primary | Recovery room length of stay | 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. | Current recovery room average length of stay is 4 hours | No |
Secondary | Hemodynamics | Intraoperative management during Cesarean section, Hemodynamics (BP, HR, Cardiac Index) | Average duration of surgery is 100 minutes | No |
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