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

NCT ID: NCT02253381

Last Updated: 2015-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2015-03-31

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.

Conditions

Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Right lateral decubitus position

Right lateral decubitus position during spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Right

Intervention Type: PROCEDURE

Right lateral decubitus position during spinal anesthesia

Left lateral decubitus position

Left lateral decubitus position during spinal anesthesia

Group Type: ACTIVE_COMPARATOR

Left

Intervention Type: PROCEDURE

Left lateral decubitus position during spinal anesthesia

Interventions

Right

Right lateral decubitus position during spinal anesthesia

Intervention Type: PROCEDURE

Left

Left lateral decubitus position during spinal anesthesia

Intervention Type: PROCEDURE

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Prince of Songkla University

OTHER

Sponsor Role: lead

Responsible Party

Panthila Rujirojindakul

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boonsin Tangtrakulwanish, MD

Role: STUDY_CHAIR

Ethical Committee

Locations

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

Hat Yai, Changwat Songkhla, Thailand

Countries

Thailand

Other Identifiers

REC: 57-195-08-1

Identifier Type: -

Identifier Source: org_study_id