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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 April 2016 |
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Main ID: |
NCT02732197 |
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Date of registration:
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04/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension
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Scientific title:
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Effects of Sedation on Spinal Anesthesia-induced Maternal Hypotension in Preoperatively Anxious Parturients Undergoing Urgent Category-1 Cesarean Section: A Historical Cohort Study |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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102 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02732197 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Retrospective
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Cenk Sahan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Design and conduct the study, review and analyze the data, and write the manuscript |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Urgent category-1 C/S
- ASA physical status I-II
- Aged between 18 and 35 years
- Term (=37 weeks) singleton pregnancy
- BMI <40 kg/m2
- Height >150 cm or <180 cm
- High preoperative anxiety scores (visual analogue scale for anxiety (VAS-A) =70)
- Spinal anesthesia with thiopental sodium sedation
- Spinal anesthesia without any sedation
Exclusion Criteria:
- Preoperative prehydration
- Placenta previa
- Placenta accreta
- Hypertension
- Pregnancy-induced hypertension
- Urgent category =2
- General anesthesia
- Spinal anesthesia with sedation other than thiopental sodium
Age minimum:
18 Years
Age maximum:
35 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Sedation
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Maternal Hypotension
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Preoperative Anxiety
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Cesarean Section
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Spinal Anesthesia
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Intervention(s)
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Drug: No sedation
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Drug: Sedation
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Primary Outcome(s)
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Maximum systolic arterial pressure (SAP) reductions from the baseline values
[Time Frame: 0-10 minutes]
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Secondary Outcome(s)
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Incidence of maternal nausea
[Time Frame: 0-30 minutes]
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Newborn Apgar score 5th min
[Time Frame: 5th min]
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Atropine requirement
[Time Frame: 0-30 minutes]
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Incidence of maternal hypotension
[Time Frame: 0-30 minutes]
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Newborn Apgar score 1st min
[Time Frame: 1st min]
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Ephedrine requirement
[Time Frame: 0-30 minutes]
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Incidence of maternal vomiting
[Time Frame: 0-30 minutes]
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Incidence of maternal bradycardia
[Time Frame: 0-30 minutes]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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