The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia

Study Overview
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Brief Summary
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The aim of this study was to examine the effect of keeping the patient in a sitting position for 1 minute after spinal anaesthesia in elective caesarean operations, primarily on the formation of hypotension and secondarily on nausea-vomiting, the need for ephedrine and the block characteristics.

Official Title
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The Effects of Keeping the Patient in a Sitting Position for One Minute After Spinal Anesthesia on Hypotension, Nausea-vomiting and Ephedrine Consumption

Conditions
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Hypotension, Spinal Anaesthesia

Intervention / Treatment
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* Procedure: sitting position
* Procedure: supine position


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18 - 45 years, ASA physical status I - II, BMI of 25-30 who were undergoing elective CS Exclusion Criteria: vertebral anomaly, peripheral vascular disease, cardiovascular or psychiatric disorder, severe anemia, coagulopathy infection in the intervention region

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br>12.5 mg 0.5% hyperbaric bupivacaine | Procedure: sitting position<br>* keeping the patient in a sitting position after spinal anaesthesia<br>|
| Active Comparator: Group 2<br>10 mg 0.5% hyperbaric bupivacaine | Procedure: supine position<br>* keeping the patient in supine position after spinal anaesthesia<br>|
| Active Comparator: Group 3<br>12.5 mg 0.5% hyperbaric bupivacaine | Procedure: supine position<br>* keeping the patient in supine position after spinal anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic arterial hypotension | reduction of >25% in the basal systolic arterial pressure | every 3 minutes until the delivery and every 5 minutes until the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory block | assesment of the time to reach T12 level with pin prick test | 10 minutes after spinal block | 
| ephedrine requirement time | the time to first administration of ephedrine as minutes after spinal block | 1 hour after spinal block | 
| amount of ephedrine | administrated total ephedrine dosage as mg during surgery | 1 hour after spinal block | 
| surgeon and patient satisfaction | 1= poor, 2=fair, 3= good, 4= very good | 24 hours after spinal block | 
| motor block | time to Bromage Score 0 after applying spinal block | 24 hours after spinal block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ephedrine, spinal anaesthesia