Spinal Anaesthesia and Severe Preeclampsia

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

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 %.

Study Overview

• Status: Unknown
• Conditions: Preeclampsia
• Intervention / Treatment: Procedure: spinal anaesthesia

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: ahmed ib elsakka, m.d.; Phone Number: 00201002414221; Email: ahmedsakka2@hotmail.com
• Study Contact Backup: Name: mina ad helmy; Email: dr_mina20002010@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: ahmed ib elsakka, m.d.; Phone Number: 00201002424221; Email: ahmedsakka2@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

two equal groups (n=30), Pregnant females with severe pre-eclampsia : (group A) and normotensive parturients (group B) presenting for full term delivery with caesarean section using spinal anesthesia at Kasr Al Aini hospital in the duration of 3 months from december 2015 to march 2016 will be included.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
preeclampsia; spinal anaesthesia will be given for cesarean section	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.
normotensive; spinal anaesthesia will be given for cesarean section	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital
• Investigators: Study Director: maher fawzy, m.d., department of anaesthesia faculty of medicine cairo university; Study Chair: nisreen refaie, m.d., department of anaesthesia faculty of medicine cairo university; Study Chair: ahmed elsakka, m.d., department of anaesthesia faculty of medicine cairo university; Principal Investigator: mina helmy, department of anaesthesia faculty of medicine cairo university

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): February 1, 2016

Study Registration Dates

• First Submitted: December 6, 2015
• First Submitted That Met QC Criteria: December 14, 2015
• First Posted (Estimate): December 17, 2015

Study Record Updates

• Last Update Posted (Estimate): December 17, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: Mina