Spinal Anaesthesia and Severe Preeclampsia

• Conditions: Preeclampsia
• Interventions: Procedure: spinal anaesthesia

• Registration Number: NCT02633995
• Lead Sponsor: Kasr El Aini Hospital

Brief 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 %.

Detailed 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.

Study Timeline

• Status Verified: 2015-12
• Study Start: 2015-12
• Study First Submitted: 2015-12-06
• Study First Submitted QC: 2015-12-14
• Last Update Submitted: 2015-12-14
• Study First Posted: 2015-12-17
• Last Update Posted: 2015-12-17
• Primary Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
preeclampsia	spinal anaesthesia	spinal anaesthesia will be given for cesarean section
normotensive	spinal anaesthesia	spinal anaesthesia will be given for cesarean section

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering	3 months

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt