Spinal Anaesthesia and Severe Preeclampsia

Preeclampsia Clinical Trial

Official title:

Spinal Anesthesia in Severe Preeclampsia and Its Impact on Hemodynamics (Case Control Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02633995
• Other study ID #: Mina
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2015
• Last updated: December 14, 2015
• Start date: December 2015

Study information

• Verified date: December 2015
• Source: Kasr El Aini Hospital
• Contact: ahmed ib elsakka, m.d.
• Phone: 00201002414221
• Email: ahmedsakka2[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The use of spinal anesthesia in pre-eclamptic pregnant woman is of considerable benefit, as these patients present particular hazards with general anaesthesia, such as concerns for rapid airway control and cerebral blood flow alterations during induction of general anaesthesia and intubation However, the incidence of hypotension is high during spinal anesthesia for Cesarean section and it may approach values up to 95 %.

Description:

The parturient will be allocated into one of two equal groups (n=30), a severe preeclampsia group (A) and a normotensive group (B). All will receive colload (500 ml voluven) as a coload via wide bore (16 Gauge ) cannula within 5-10 minutes during induction of spinal anesthesia. Standard monitoring with electrocardiography, automated non-invasive arterial pressure (NIAP) measurement, and pulse oximetry will be performed. Systolic arterial pressure (SAP), mean arterial pressure (MAP) and diastolic arterial pressure (DAP) will be monitored. Baseline values will be recorded in the supine position. Central venous line will be inserted in severe preeclampsia group and central venous pressure will be measured every 10 minutes.

Spinal anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age: 18 - 40 years

• Severely Pre-eclamptic females, severe pre-eclampsia is defined as hypertension( BP > 159/109) ,proteinuria ( urinary protein excretion of greater than 5 gm per day) and oliguria(<500 ml in 24 hours) with at least one maternal organ dysfunction .

Exclusion Criteria:

• Age : <18 years

• Obese patients with BMI > 35 Kg/m2

• Preterm delivery

• Patients with contraindication to spinal anesthesia.

• Patients in active labor

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Procedure:
• spinal anaesthesia
regional anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants showing significant hemodynamic changes in response to spinal anesthesia as detected by hemodynamic monitors (blood pressure, heart rate and oxygen saturation)		3 months	No
Secondary	Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering		3 months	No