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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

Tracking Information
First Submitted Date December 6, 2015
First Posted Date December 17, 2015
Last Update Posted Date December 17, 2015
Study Start Date December 2015
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 14, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 14, 2015)
Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering [ Time Frame: 3 months ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Spinal Anaesthesia and Severe Preeclampsia
Official Title Spinal Anesthesia in Severe Preeclampsia and Its Impact on Hemodynamics (Case Control Study)
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 Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Preeclampsia
Intervention 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.
Study Groups/Cohorts
  • preeclampsia
    spinal anaesthesia will be given for cesarean section
    Intervention: Procedure: spinal anaesthesia
  • normotensive
    spinal anaesthesia will be given for cesarean section
    Intervention: Procedure: spinal anaesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 14, 2015)
60
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT02633995
Other Study ID Numbers Mina
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party ahmed elsakka, Cairo University
Study Sponsor Kasr El Aini Hospital
Collaborators Not Provided
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
PRS Account Kasr El Aini Hospital
Verification Date December 2015