Spinal Anaesthesia and Severe Preeclampsia

NCT02633995 | Unknown

• 1 other identifier: Mina
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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 %.

Conditions

Preeclampsia

Outcome Measures

Primary Outcomes (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)

  3 months

Secondary Outcomes (1)

• Percentage of participants showing short term adverse side effects in response to spinal anesthesia as nausea, vomiting and shivering

  3 months

Study Arms (2)

preeclampsia

spinal anaesthesia will be given for cesarean section

Procedure: spinal anaesthesia

normotensive

spinal anaesthesia will be given for cesarean section

Procedure: spinal anaesthesia

Interventions

spinal anaesthesia 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; preeclampsia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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 .

You may not qualify if:

• Age : \<18 years
• Obese patients with BMI \> 35 Kg/m2
• Preterm delivery
• Patients with contraindication to spinal anesthesia.
• Patients in active labor

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• maher fawzy, m.d.

  department of anaesthesia faculty of medicine cairo university

  STUDY DIRECTOR

• 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

  STUDY CHAIR

• mina helmy

  department of anaesthesia faculty of medicine cairo university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed ib elsakka, m.d.

CONTACT

00201002414221; ahmedsakka2@hotmail.com

mina ad helmy

CONTACT

dr_mina20002010@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anaesthesia faculty of medicine cairo university

Study Record Dates

• First Submitted: December 6, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: February 1, 2016
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

EG (1)