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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673253
• Other study ID #: AntalyaEAH03
• Status: Completed
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: February 2021
• Source: Antalya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Parturients who are planned for the elective cesarean section

Exclusion Criteria:

• Failed spinal block

• Shift to general anesthesia

• Severe cardiac disease

• Hypertensive disorders of pregnancy

Related Conditions & MeSH terms

• Hypotension

Intervention

Other:
• Passive leg Raise
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.
• control
The controlled group was positioned in the normal supine position.

Locations

Country	Name	City	State
Turkey	University of Health Sciences, Antalya Training and Research Hospital	Antalya

Sponsors (1)

Lead Sponsor	Collaborator
Antalya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	Before the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	1 minute after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	2 minutes after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	3 minutes after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	4 minutes after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	5 minutes after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	7 minutes after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	9 minutes after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	11 minutes after the spinal anesthesia in the supine position
Primary	Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	1 minute after the umblical cord clamping