Post-anesthesia Recovery Clinical Trial
Official title:
Electroencephalographic Effects of Ketamine During Isoflurane Maintenance and Recovery
Ketamine effect on isoflurane anesthesia This study is designed to study the effect of
ketamine on isoflurane anesthesia. As both drugs are hypnotic and are used to cause sleep
during surgery and other painful procedures, it was long believed that the actions of two
drugs add to each other. For example if a man received both drugs, this man will become awake
from anesthesia much later than if this man was given either of them alone.
However recent studies showed that this is not the case and ketamine can cause fast recovery
from hypnotic effects of isoflurane. This was confirmed in animals.
The aim of current study is to investigate if this effect applies for humans, using a state
of art brain monitoring device in wide use nowadays called BIS or bispectral index. This
device can also shed some light on how ketamine can cause, if any, fast recovery from
isoflurane anesthesia. Simply, by studying electrical wave coming from brain to head skin.
In an animal study, the authors found that intraperitoneal injection of a sub-anesthetic dose
of ketamine amidst isoflurane anesthesia in rats induced early recovery. A finding the
authors explained, to be due to increased NMDA mediated increase of acetyl choline secretion
in the prefrontal area of rats' brains. This rise, in the authors opinion, antagonized the
GABA mediated isoflurane anesthesia resulting in hastened recovery. Meanwhile, the authors
found association between hastened recovery and increased Electroencephalographic gamma (EEG
γ) wave fronto-parietal projection. This is compatible with cognitive unbinding explanation
of unconsciousness during anesthesia.
In current proposed study, the investigator will examine tow hypothesis:
Recovery time:
If the recovery hastening effect of sub anesthetic ketamine on recovery from isoflurane
anesthesia is also present in human patients. The assumption will be that ketamine either
prolong or has no effect on recovery time from isoflurane anesthesia. The claim well be that
ketamine will decrease the recovery time.
Put in statistical terms:
H0: recovery with ketamine ≥ recovery without ketamine. H1: recovery with ketamine ˂ recovery
without ketamine. 2. EEG (γ) wave activity: As the investigator will record EEG activity
during the procedure via Bispectral monitor, the investigator will analyze the records for
presence of enhanced (γ) activity during recovery. the investigator aim is also to detect any
significant difference in (γ) wave amplitude or other characteristics between isoflurane only
and ketamine group.
The assumption will be that (γ) activity will either show no difference between the two
groups or be lower than in ketamine group than isoflurane group during recovery. The claim
will be increased (γ) activity with ketamine group during recovery.
Put in statistical terms:
H0: (γ) activity with ketamine ≤ isoflurane only. H1: (γ) activity with ketamine > isoflurane
only. N.P: as the sampling frequency of EEG data exported from BIS Vista is 128Hz, the upper
limit of the current study of (γ) activity will necessarily be 64Hz.
Sample size calculation:
the mean measured variable of the current study will be the recovery time. Recovery time will
be defined as the time between stop of isoflurane inhalation until recovery of verbal
response to name called every 30 seconds. A 30% reduction in recovery time in ketamine group
as compared with isoflurane is considered to be statically significant enough to reject the
null hypothesis of recovery time. According to one study , recovery time from isoflurane only
anesthesia is around 12 minutes so the sample size calculation will be as following:
Equation:
n>((ᶻ "1- α ̸2" +ᶻ"1-β" )"2" σ"2" )/δ"2" Where n = sample size required for each group, ᶻ
"1-α" = the value for the standard normal distribution for (1-α̸2) percentile, ᶻ "1-β" =the
standard normal distribution for 100(1-β) percentile, δ"2" = the difference to detect, σ"2" =
the variance in the underling 2 population.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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| Completed |
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