General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome

Conditions
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HELLP Syndrome

Intervention / Treatment
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* Procedure: Spinal Anesthesia
* Procedure: General Anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Spinal Anesthesia<br>Spinal anesthesia will be used to anesthetize patients in this group for caesarian section | Procedure: Spinal Anesthesia<br>* 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.<br>|
| Active Comparator: General Anesthesia<br>Standardized General Anesthesia will be used to anesthetize patients in this group for caesarian section | Procedure: General Anesthesia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of perioperative mortality in both groups. | Maternal | up to one week postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurence bradycardia | heart rate less than 50 beat/min | up to 24 hours postoperative | 
| occurrence of tachycardia | heart rate more than 120 beats/min | up to 24 hours postoperative | 
| occurrence of hypotension | mean arterial blood pressure < 40% of the baseline | up to 24 hours postoperative | 
| occurrence of hypertension | mean arterial blood pressure > 40% of the baseline | up to 24 hours postoperative | 
| incidence of cerebral hemorrhage | detected by CT in patients with neurological deficits | up to one week postoperative |