Clinical Trial: General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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 ch
Sponsor: Assiut University

Current Primary Outcome: The incidence of perioperative mortality in both groups. [ Time Frame: up to one week postoperative ]

Maternal


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Assiut University

Dates:
Date Received: March 27, 2017
Date Started: April 15, 2017
Date Completion: September 1, 2017
Last Updated: April 7, 2017
Last Verified: April 2017