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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02253381
• Other study ID #: REC: 57-195-08-1
• Status: Completed
• Phase: N/A
• First received: September 27, 2014
• Last updated: April 27, 2015
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension

Intervention

Procedure:
• Right
Right lateral decubitus position during spinal anesthesia
• Left
Left lateral decubitus position during spinal anesthesia

Locations

Country	Name	City	State
Thailand	Department of anesthesiology, Faculty of Medicine, Prince of Songkla University	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypotension	Systolic blood pressure lower than 90 mmHg or decrease more than 20% of baseline	after bupivacaine injection until 15 minutes after spinal anesthesia	Yes
Secondary	Ephedrine consumption	Total amount of ephedrine receiving	intraoperative	Yes
Secondary	Apgar score at first minute and fifth minute		Child delivery at first minute and fifth minute	Yes