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General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome

Primary Purpose

HELLP Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Spinal Anesthesia
General Anesthesia
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HELLP Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Patients with class (II) (12) HELLP syndrome scheduled for elective caesarian section:

Diagnosis of HELLP syndrome was based on the clinical diagnosis of preeclampsia and the following laboratory abnormalities (13):

  1. Hemolysis: characteristic peripheral blood smear, serum lactic dehydrogenase (LDH) ≥ 600 U/ l, total bilirubin ≥ 1.2 mg /dl, decreased hemoglobin and hematocrit.
  2. Elevated liver enzymes, defined as aspartate aminotransferase (AST). ≥ 70 U/ l, alanin aminotransferase (ALT) ≥ 50 U/ l and lactate dehydrogenase (LDH) ≥ 600 U/ l.
  3. Low platelet count: class 2 HELLP having a platelet nadir between > 50000 and 100000 mm-3.

Exclusion Criteria:

  1. Emergency cases
  2. Placenta praevia
  3. Cardiovascular or cerebrovascular disease.
  4. Morbid obesity with a BMI ≥40
  5. Gestational age <36 or >41 weeks
  6. Platelet counts less than 50000 mm-3; class 1 HELLP and class 3 HELLP having platelet count more than 100 000 mm-3

Sites / Locations

  • Assiut university hospital, Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Spinal Anesthesia

General Anesthesia

Arm Description

Spinal anesthesia will be used to anesthetize patients in this group for caesarian section

Standardized General Anesthesia will be used to anesthetize patients in this group for caesarian section

Outcomes

Primary Outcome Measures

The incidence of perioperative mortality in both groups.
Maternal

Secondary Outcome Measures

occurence bradycardia
heart rate less than 50 beat/min
occurrence of tachycardia
heart rate more than 120 beats/min
occurrence of hypotension
mean arterial blood pressure < 40% of the baseline
occurrence of hypertension
mean arterial blood pressure > 40% of the baseline
incidence of cerebral hemorrhage
detected by CT in patients with neurological deficits

Full Information

First Posted
March 27, 2017
Last Updated
May 17, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03111446
Brief Title
General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome
Official Title
General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
December 1, 2017 (Actual)
Study Completion Date
January 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Anesthesia for caesarian section in patients with HELLP syndrome is a challenge. Measures should be taken during caesarian delivery to guard against the maternal and fetal complications associated with HELLP syndrome.
Detailed Description
The choice of anesthesia for caesarian section in parturient with HELLP syndrome is a debate. The low platelet count, associated with HELLP syndrome, has often favored the choice of general anesthesia for the caesarian delivery of these parturient. However, general anesthesia in such cases; is not a risk-free approach. General anesthesia is associated with increased risk of difficult airways, stress response to intubation and aspiration. It is also thought to have an effect on the fetus with the potential placental transfer of inhalational anesthetics prior to delivery. Regional anesthesia is widely regarded as a means of providing analgesia for cesarean section.it also avoids the above-mentioned risks associated with general anesthesia. Regional anesthesia for caesarian section in patients with HELLP syndrome has been used by some researchers in many centers with encouraging results. The lowest platelet count at which one can safely administer neuraxial anesthesia for labour and delivery is controversial. Published studies are few and sample sizes small. Criteria developed at the University of Mississippi, as of 2006: "For a patient to merit a diagnosis of HELLP syndrome, class 1 requires severe thrombocytopenia (platelets ≤50,000/μl), evidence of hepatic dysfunction (AST and/or ALT ≥70 IU/l), and evidence suggestive of hemolysis (total serum LDH ≥600 IU/l); class 2 requires similar criteria except thrombocytopenia is moderate (>50,000 to ≤100,000/μl); and class 3 includes patients with mild thrombocytopenia (platelets >100,000 but ≤150,000/μl), mild hepatic dysfunction (AST and/or ALT ≥40 IU/l), and hemolysis (total serum LDH ≥600 IU/L). The researchers chose to investigate class 2 HELLP syndrome as class 3 proved to be safe with regional anesthesia while class 1 seemed to be high risk and un-ethical to do spinal anesthesia with very low platelets count with lack of any evidence to its safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HELLP Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spinal Anesthesia
Arm Type
Active Comparator
Arm Description
Spinal anesthesia will be used to anesthetize patients in this group for caesarian section
Arm Title
General Anesthesia
Arm Type
Active Comparator
Arm Description
Standardized General Anesthesia will be used to anesthetize patients in this group for caesarian section
Intervention Type
Procedure
Intervention Name(s)
Spinal Anesthesia
Intervention Description
Spinal needle 25G with Quincke's bevel will be used. It will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 20 mcg fentanyl (total volume 2.4 ml) at the L3-4 interspace. The parturient will be returned to the supine position with a left lateral tilt of 15° to facilitate left uterine displacement. The upper sensory block level will be checked 5 min after the spinal injection by assessing the loss of cold sensation from alcohol swabs, to ensure that a Th6 sensory block level has been achieved.
Intervention Type
Procedure
Intervention Name(s)
General Anesthesia
Intervention Description
Pre-oxygenation with oxygen 100% via a tight fitting mask rapid sequence technique. Induction is by thiopental (5 mg kg lean body weight) and succinylcholine1.5 mg kg body weight), cricoid pressure should be applied before consciousness is lost and kept in place until confirmation of tracheal intubation with capnography and the cuff of the tracheal tube is inflated. Auscultating the chest helps exclude endobronchial intubation. At this point, surgery may commence.
Primary Outcome Measure Information:
Title
The incidence of perioperative mortality in both groups.
Description
Maternal
Time Frame
up to one week postoperative
Secondary Outcome Measure Information:
Title
occurence bradycardia
Description
heart rate less than 50 beat/min
Time Frame
up to 24 hours postoperative
Title
occurrence of tachycardia
Description
heart rate more than 120 beats/min
Time Frame
up to 24 hours postoperative
Title
occurrence of hypotension
Description
mean arterial blood pressure < 40% of the baseline
Time Frame
up to 24 hours postoperative
Title
occurrence of hypertension
Description
mean arterial blood pressure > 40% of the baseline
Time Frame
up to 24 hours postoperative
Title
incidence of cerebral hemorrhage
Description
detected by CT in patients with neurological deficits
Time Frame
up to one week postoperative

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Parturients with HELLP syndrome presented for elective caesarian section
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with class (II) (12) HELLP syndrome scheduled for elective caesarian section: Diagnosis of HELLP syndrome was based on the clinical diagnosis of preeclampsia and the following laboratory abnormalities (13): Hemolysis: characteristic peripheral blood smear, serum lactic dehydrogenase (LDH) ≥ 600 U/ l, total bilirubin ≥ 1.2 mg /dl, decreased hemoglobin and hematocrit. Elevated liver enzymes, defined as aspartate aminotransferase (AST). ≥ 70 U/ l, alanin aminotransferase (ALT) ≥ 50 U/ l and lactate dehydrogenase (LDH) ≥ 600 U/ l. Low platelet count: class 2 HELLP having a platelet nadir between > 50000 and 100000 mm-3. Exclusion Criteria: Emergency cases Placenta praevia Cardiovascular or cerebrovascular disease. Morbid obesity with a BMI ≥40 Gestational age <36 or >41 weeks Platelet counts less than 50000 mm-3; class 1 HELLP and class 3 HELLP having platelet count more than 100 000 mm-3
Facility Information:
Facility Name
Assiut university hospital, Faculty of medicine
City
Assiut
ZIP/Postal Code
71516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome

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