Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?

NCT04673253 | Completed

• 1 other identifier: AntalyaEAH03
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

All over the world, spinal anesthesia is widely used in cesarean sections due to its superiority over general anesthesia. Due to reasons such as increased sensitivity to local anesthetics and increased intra-abdominal pressure in pregnant women, the frequency of hypotension increases by up to 70%. As a result of the blockage of sympathetic vasoconstrictor fibers originating from T1-L2 segments, loss of peripheral resistance, venous ponding occurs, and cardiac output decreases. Also, the level required for cesarean operation is T4 or T5, and the possibility of affecting the cardiac accelerator fibers, so bradycardia due to the increase in parasympathetic activity may deepen the hypotension. If postspinal hypotension is not managed correctly, it may lead to maternal and fetal complications. In addition to classical methods such as fluid loading and prophylactic vasoconstrictor application to prevent hypotension in pregnant women after spinal anesthesia, techniques such as wrapping the lower extremity, lifting, or applying both together have been in question. Passive leg raise application is an easy method that allows the blood collected in the lower part of the body to participate in the central circulation with the effect of gravity. An increase in venous return occurs with the passage of blood from the lower extremities to the thorax. Thus, it leads to an increase in stroke volume and an increase in cardiac output. In this study, we aimed to determine the effectiveness of passive leg raising in preventing or reducing the depth of hypotension after spinal anesthesia in pregnant women who underwent cesarean section under spinal anesthesia.

Conditions

Hypotension

Keywords

cesarean section; hypotension; spinal anesthesia; passive leg raise

Outcome Measures

Primary Outcomes (10)

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  Before the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  1 minute after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  2 minutes after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  3 minutes after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  4 minutes after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  5 minutes after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  7 minutes after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  9 minutes after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  11 minutes after the spinal anesthesia in the supine position

• Systolic blood pressure

  Systolic blood pressure will be recorded from the monitor

  1 minute after the umblical cord clamping

Study Arms (2)

Passive leg raise

ACTIVE COMPARATOR

group for passive leg raise

Other: Passive leg Raise

Control

PLACEBO COMPARATOR

Other: control

Interventions

Passive leg Raise OTHER

The intervention will be performed immediately after spinal anesthesia, and passive leg raise will be performed using two standard pillows placed under the heel so that the leg is approximately 30 cm above the horizontal plane of the table. The passive leg raising position will continue until the cord is clamped.

Passive leg raise

control OTHER

The controlled group was positioned in the normal supine position.

Control

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parturients who are planned for the elective cesarean section

You may not qualify if:

• Failed spinal block
• Shift to general anesthesia
• Severe cardiac disease
• Hypertensive disorders of pregnancy

Sponsors & Collaborators

• Antalya Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 17, 2020
• Study Start: November 15, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)