Clinical trial NCT03111446: 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
Overall status: COMPLETED
Phase: NA
Conditions: HELLP Syndrome
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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):

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

Primary outcomes:
measure: The incidence of perioperative mortality in both groups.
timeFrame: up to one week postoperative
Secondary outcomes:
measure: occurence bradycardia
timeFrame: up to 24 hours postoperative
measure: occurrence of tachycardia
timeFrame: up to 24 hours postoperative
measure: occurrence of hypotension
timeFrame: up to 24 hours postoperative
measure: occurrence of hypertension
timeFrame: up to 24 hours postoperative
measure: incidence of cerebral hemorrhage
timeFrame: up to one week postoperative
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university hospital, Faculty of medicine
Study officials:
References: