Rapid Reversal of CNS-Depressant Drug Effect Prior to Brain Death Determination
Status:
Withdrawn
Trial end date:
2021-07-21
Target enrollment:
Participant gender:
Summary
Current standard of care prior to determination of brain death in subjects with suspected
anoxic brain injury is to exclude complicating medical conditions that may confound clinical
assessment (such as severe electrolyte, acid base, endocrine or circulatory disturbance),
achieve normothermia and normal systolic blood pressure over 100 mmHg (with or without
vasopressor use), exclude the presence of neuromuscular blocking agents (with the presence of
a train of 4 twitches with maximal ulnar nerve stimulation) as well as to exclude the
presence of CNS depressant drug effects. At the present time the latter is done by history,
drug screen and allowing enough time for paralytic and sedative drugs to be metabolized and
cleared from the body. Clearance is calculated by using 5 times the drug's half-life assuming
normal hepatic and renal functions. Half-life can also be prolonged in subjects who have been
treated with induced hypothermia. Literature search revealed articles with general guidelines
and approaches to brain death, but none addressed pharmacological reversal of sedative drugs
Phase:
Early Phase 1
Details
Lead Sponsor:
Prisma Health-Midlands Sameh Hanna, MD
Treatments:
Central Nervous System Depressants Flumazenil Naloxone