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Spinal Anaesthesia and Severe Preeclampsia

NCT ID: NCT02633995

Last Updated: 2015-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Preeclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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preeclampsia

spinal anaesthesia will be given for cesarean section

spinal anaesthesia

Intervention Type PROCEDURE

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

spinal anaesthesia

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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ahmed elsakka

lecturer of anaesthesia faculty of medicine cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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maher fawzy, m.d.

Role: STUDY_DIRECTOR

department of anaesthesia faculty of medicine cairo university

nisreen refaie, m.d.

Role: STUDY_CHAIR

department of anaesthesia faculty of medicine cairo university

ahmed elsakka, m.d.

Role: STUDY_CHAIR

department of anaesthesia faculty of medicine cairo university

mina helmy

Role: PRINCIPAL_INVESTIGATOR

department of anaesthesia faculty of medicine cairo university

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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ahmed ib elsakka, m.d.

Role: CONTACT

Phone: 00201002414221

Email: [email protected]

mina ad helmy

Role: CONTACT

Email: [email protected]

Facility Contacts

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ahmed ib elsakka, m.d.

Role: primary

Other Identifiers

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Mina

Identifier Type: -

Identifier Source: org_study_id