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Spinal Anaesthesia and Severe Preeclampsia

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02633995
Enrollment
60
Registered
2015-12-17
Start date
2015-12-31
Completion date
Unknown
Last updated
2015-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preeclampsia

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.

Interventions

PROCEDUREspinal 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.

Sponsors

Kasr El Aini Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering3 months

Countries

Egypt

Contacts

Primary Contactahmed ib elsakka, m.d.
ahmedsakka2@hotmail.com00201002414221
Backup Contactmina ad helmy
dr_mina20002010@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026