Effect of Position During Spinal Anesthesia on Hemodynamic Change in Cesarean Section

Study Overview
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Brief Summary
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Hypotension is the most common complications after spinal anesthesia especially in pregnant patients who undergoing cesarean section. Position during spinal anesthesia may be altering the hemodynamic. For right lateral decubitus, the enlarged uterus compresses inferior vena cava that may decrease venous return and cardiac output. This leads to hypotension.The hypothesis is the right lateral position during spinal anesthesia in pregnant women will be had hemodynamic changing more than the left lateral position. This objective is to compare hemodynamic change between left and right lateral position during spinal anesthesia in pregnant women undergoing cesarean section.

Detailed Description
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Study design: A randomized controlled trial Study setting: The study will be conducted in the operating rooms at Songklanagarind Hospital, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand Study period: The total duration of participation in the randomized study is up to the operative day. Study population: Pregnant patients undergoing cesarean section receiving spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml. Study sample: Inclusion criteria Signed informed consent Pregnancy Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml Elective and emergency surgery Exclusion criteria Contraindication for spinal anesthesia Complicated pregnancy such as maternal heart disease, eclampsia, severe fetal distress, abruption placenta, twin pregnancy, and placenta previa totalis Maternal height < 150 cm.

Official Title
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Effect of Position During Spinal Anesthesia on Hemodynamic Change in Pregnant Women Undergoing Cesarean Section: Randomized Trial

Conditions
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Hypotension

Intervention / Treatment
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* Procedure: Right
* Procedure: Left


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Term pregnancy Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml Exclusion Criteria: Contraindication for spinal anesthesia Height < 150 cm. Complicated pregnancy e.g. heart disease, preclampsia, eclampsia, diabetes millitus, twin, abrupt placenta, placenta pre via, and fetal distress Failed spinal anesthesia
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Right lateral decubitus position<br>Right lateral decubitus position during spinal anesthesia | Procedure: Right<br>* Right lateral decubitus position during spinal anesthesia<br>|
| Active Comparator: Left lateral decubitus position<br>Left lateral decubitus position during spinal anesthesia | Procedure: Left<br>* Left lateral decubitus position during spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypotension | Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline | after bupivacaine injection until 15 minutes after spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ephedrine consumption | Total amount of ephedrine receiving | intraoperative | 
| Apgar score at first minute and fifth minute |  | Child delivery at first minute and fifth minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lateral decubitus position, hypotension, cesarean section