Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section

Cesarean Clinical Trial

Official title:

Norepinephrine Versus Ephedrin for Prevention of Post Spinal Anesthesia in Cesarean Section

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03719625
• Other study ID #: prophylactic vasopressors
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2, 2019
• Est. completion date: May 30, 2019

Study information

• Verified date: October 2018
• Source: Mongi Slim Hospital
• Contact: Asma Ben Souissi, assistant professor
• Phone: 0021698336883
• Email: bsouissiasma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration.

The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

Description:

Spinal anesthesia is still the gold standard anesthetic method for elective and urgent cesarean section, the post spinal hypotension remains the most frequent complication of this procedure and is still responsible of considerable maternel and fetal morbidity. It is recommanded to prevent this post spinal hypotension with fluid coloading and prophylactic vasopressors administration. The prophylactic use of norepinephrin and phenylephrin has been validated by several studies, but few data are published concerning the comparaison between norepinephrin and ephedrine as preventive vasopressors in cesarean section; these molecules act on alpha and beta adrenergic receptors and could provide better maternal hemodynamics in parturients undergoing cesarean section under spinal anesthesia.

The aim of this study is to compare the efficency and the safety of norepinephrin and ephedrin prophylactic administration to reduce the incidence of post spinal hypotension in cesarean section.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 30, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• full termed parturients scheduled for elective or semi urgent cesarean section under spinal anesthesia

• AGE>15 years

• ASA II status

• No history of hypertension, preeclampsia or cardiopathy

• BMI<40

Exclusion Criteria:

• cesarean section under genearl anesthesia or epidural analgesia during labor

Related Conditions & MeSH terms

• Cesarean
• Hypotension
• Maternal Hypotension Syndrome
• Obstetric Labor Complications

Intervention

Drug:
• Ephedrine
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
• Norepinephrine
Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post spinal hypotension	decrease of systolic arterial blood pressure > 20% baseline	during the first 20 minutes after spinal anesthesia
Secondary	Lowest systolic blood pressure	Lowest systolic blood pressure recorded after spinal anesthesia	uring the first 20 minutes after spinal anesthesia
Secondary	Incidence of bradycardia	heart rate<50 beats/min	during the first 20 minutes after spinal anesthesia
Secondary	incidence of nausea and/or vomiting	incidence of nausea and/or vomiting	during the first 20 minutes after spinal anesthesia
Secondary	Apgar score	Apgar score at 1 min, 5 min, 10 min	20min after spinal anesthesia
Secondary	fetal ph	fetal ph	20min after spinal anesthesia
Secondary	fetal blood lactates	fetal blood lactates	20min after spinal anesthesia