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Clinical Trials/NCT02253381
NCT02253381
Completed
Not Applicable

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

Prince of Songkla University1 site in 1 country140 target enrollmentOctober 2014
ConditionsHypotension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension
Sponsor
Prince of Songkla University
Enrollment
140
Locations
1
Primary Endpoint
Hypotension
Status
Completed
Last Updated
11 years ago

Overview

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 1. Signed informed consent 2. Pregnancy 3. Spinal anesthesia with 0.5% bupivacaine and 0.2 mg morphine total volume 2.2 ml 4. Elective and emergency surgery Exclusion criteria 1. Contraindication for spinal anesthesia 2. Complicated pregnancy such as maternal heart disease, eclampsia, severe fetal distress, abruption placenta, twin pregnancy, and placenta previa totalis 3. Maternal height \< 150 cm.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
March 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Panthila Rujirojindakul

Dr

Prince of Songkla University

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

Outcomes

Primary Outcomes

Hypotension

Time Frame: after bupivacaine injection until 15 minutes after spinal anesthesia

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

Secondary Outcomes

  • Apgar score at first minute and fifth minute(Child delivery at first minute and fifth minute)
  • Ephedrine consumption(intraoperative)

Study Sites (1)

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