General Anesthesia Versus Spinal Anesthesia in Patients of HELLP Syndrome

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.

Study Overview

• Status: Completed
• Conditions: HELLP Syndrome
• Intervention / Treatment: Procedure: Spinal Anesthesia; Procedure: General Anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71516
    • Assiut university hospital, Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2017
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 27, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Pregnancy Complications; Hypertension, Pregnancy-Induced; Syndrome; HELLP Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: SpinalHELLP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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