Effect of Position During Spinal Anesthesia on Hemodynamic Change in Cesarean Section
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2014
CompletedFirst Posted
Study publicly available on registry
October 1, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 29, 2015
April 1, 2015
5 months
September 27, 2014
April 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Ephedrine consumption
intraoperative
Apgar score at first minute and fifth minute
Child delivery at first minute and fifth minute
Study Arms (2)
Right lateral decubitus position
ACTIVE COMPARATORRight lateral decubitus position during spinal anesthesia
Left lateral decubitus position
ACTIVE COMPARATORLeft lateral decubitus position during spinal anesthesia
Interventions
Eligibility Criteria
You may qualify if:
- Signed informed consent
- Term pregnancy
- Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of anesthesiology, Faculty of Medicine, Prince of Songkla University
Hat Yai, Changwat Songkhla, 90110, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boonsin Tangtrakulwanish, MD
Ethical Committee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
September 27, 2014
First Posted
October 1, 2014
Study Start
October 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 29, 2015
Record last verified: 2015-04