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

Primary Purpose

Hypotension

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Right
Left
Sponsored by
Prince of Songkla University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring lateral decubitus position, hypotension, cesarean section

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of anesthesiology, Faculty of Medicine, Prince of Songkla University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Right lateral decubitus position

Left lateral decubitus position

Arm Description

Right lateral decubitus position during spinal anesthesia

Left lateral decubitus position during spinal anesthesia

Outcomes

Primary Outcome Measures

Hypotension
Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline

Secondary Outcome Measures

Ephedrine consumption
Total amount of ephedrine receiving
Apgar score at first minute and fifth minute

Full Information

First Posted
September 27, 2014
Last Updated
April 27, 2015
Sponsor
Prince of Songkla University
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1. Study Identification

Unique Protocol Identification Number
NCT02253381
Brief Title
Effect of Position During Spinal Anesthesia on Hemodynamic Change in Cesarean Section
Official Title
Effect of Position During Spinal Anesthesia on Hemodynamic Change in Pregnant Women Undergoing Cesarean Section: Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Prince of Songkla University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
lateral decubitus position, hypotension, cesarean section

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right lateral decubitus position
Arm Type
Active Comparator
Arm Description
Right lateral decubitus position during spinal anesthesia
Arm Title
Left lateral decubitus position
Arm Type
Active Comparator
Arm Description
Left lateral decubitus position during spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
Right
Intervention Description
Right lateral decubitus position during spinal anesthesia
Intervention Type
Procedure
Intervention Name(s)
Left
Intervention Description
Left lateral decubitus position during spinal anesthesia
Primary Outcome Measure Information:
Title
Hypotension
Description
Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline
Time Frame
after bupivacaine injection until 15 minutes after spinal anesthesia
Secondary Outcome Measure Information:
Title
Ephedrine consumption
Description
Total amount of ephedrine receiving
Time Frame
intraoperative
Title
Apgar score at first minute and fifth minute
Time Frame
Child delivery at first minute and fifth minute

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boonsin Tangtrakulwanish, MD
Organizational Affiliation
Ethical Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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

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