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Trial record 33 of 153 for:    severe preeclampsia AND Pregnancy Complications

Spinal Anaesthesia and Severe Preeclampsia

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ClinicalTrials.gov Identifier: NCT02633995
Recruitment Status : Unknown
Verified December 2015 by ahmed elsakka, Cairo University.
Recruitment status was:  Recruiting
First Posted : December 17, 2015
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
ahmed elsakka, Cairo University

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 %.

Condition or disease Intervention/treatment
Preeclampsia 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Spinal Anesthesia in Severe Preeclampsia and Its Impact on Hemodynamics (Case Control Study)
Study Start Date : December 2015
Estimated Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Percentage of participants showing significant hemodynamic changes in response to spinal anesthesia as detected by hemodynamic monitors (blood pressure, heart rate and oxygen saturation) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633995


Contacts
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Contact: ahmed ib elsakka, m.d. 00201002414221 ahmedsakka2@hotmail.com
Contact: mina ad helmy dr_mina20002010@yahoo.com

Locations
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Egypt
Cairo University Recruiting
Cairo, Egypt
Contact: ahmed ib elsakka, m.d.    00201002424221    ahmedsakka2@hotmail.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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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

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Responsible Party: ahmed elsakka, lecturer of anaesthesia faculty of medicine cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT02633995     History of Changes
Other Study ID Numbers: Mina
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs