Skip to main content
OpenTrials
Completed

NCT Number: NCT02253381

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Right

Procedure

Right lateral decubitus position during spinal anesthesia

Left

Procedure

Left lateral decubitus position during spinal anesthesia

Primary outcomes

  1. 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

  1. Ephedrine consumption

    Time frame: intraoperative

    Total amount of ephedrine receiving

  2. Apgar score at first minute and fifth minute

    Time frame: Child delivery at first minute and fifth minute

Sponsors and collaborators

Lead sponsor

Prince of Songkla University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 1, 2014
Registry last updated
Apr 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.