Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy Clinical Trial

Official title:

Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03488277
• Other study ID #: Mater1
• Status: Recruiting
• Phase: N/A
• First received: March 22, 2018
• Last updated: March 28, 2018
• Start date: January 10, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2018
• Source: Mongi Slim Hospital
• Contact: Mhamed Sami Mebazaa, professor
• Phone: 0021622252589
• Email: msmebazaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:

LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.

Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil.

Description:

Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups:

LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction.

Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil. we will record the demographic data, pre and intraoperative hemodynamic parameters, the dose of ephedrine required to treat post spinal hypotension and fetal parameters: pH and blood lactates

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• full term parturients

• age> 18 Y

• scheduled of elective or urgent cesarean section under spinal anesthesia

Exclusion Criteria:

• patients who had general anesthesia

Related Conditions & MeSH terms

• Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
• Hypotension

Intervention

Other:
• leg elevation
intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels

Locations

Country	Name	City	State
Tunisia	Mongi Slim Hospital	La Marsa	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post spinal hypotension	change of systolic blood pressure from baseline< 90 mmHg	during the first 30minutes after the spinal anesthesia
Secondary	Lowest systolic blood pressure	the lowest systolic blood pressure observed after spinal anesthesia	during the first 30 minutes following spinal anesthesia
Secondary	ephedrine consumption	total dose of Ephedrine received to treat post spinal hypotension	during the first 30 minutes following the spinal anesthesia
Secondary	Fetal ph	fetal ph measured with blood gas analysis	30 minutes after spinal anesthesia
Secondary	Fetal blood lactates	fetal blood lactates (mmol/L) measured with blood gas analysis	30 minutes after spinal anesthesia