Intraoperative Awareness Clinical Trial
Official title:
Evaluation of Closed Loop Anaesthesia Delivery System for Propofol Anaesthesia in Pediatric Cardiac Surgery
The purpose of the study is to evaluate and compare the feasibility, efficacy and safety of IAADS (Improved Anaesthetic Agent Delivery System) for propofol anaesthesia against manual control using bispectral index in paediatric patients undergoing open heart surgery under cardio-pulmonary bypass.
Automated drug delivery has gained considerable interest in recent times. It is carried out
by specially programmed electro-mechanical devices where dose rate adjustment is made
independent of human intervention. The desired target is chosen by the clinician. The closed
loop system depends upon a feedback signal to modify the rate of drug delivery. These have
an advantage that they are able to overcome the individual pharmacokinetic and
pharmacodynamic differences as well as the differing levels of surgical stimulation.
Majority of studies on closed loop delivery of hypnotics has been done using propofol.
CLADS(Closed loop anesthesia delivery system) is a BIS guided closed loop anaesthesia
delivery system developed at PGIMER (Post graduate institute of medical education and
research), Chandigarh and has been used successfully for administration of propofol in
various situations, eg, non-cardiac surgery, cardiac surgery, post-operative sedation and
high altitude. The system used will be IAADS, Improved anesthetic agent delivery system -
the present and updated version of CLADS), a pharmacokinetic-pharmacodynamic model based
adaptive system . There are only a few studies/reports regarding closed loop delivery of
muscle relaxants in children. In this study, the efficacy of IAADS will be compared with
manual control for administration of propofol using BIS as a control variable during
induction and maintenance of anaesthesia in children undergoing elective open heart surgery.
After approval from the Institutional ethics committee and written informed parental
consent, 40 children, aged 5-18 years and ASA physical status II-III, planned for elective
open heart surgery under general anaesthesia will be studied. Patients will be randomly
allocated to one of two groups - the manual group and the IAADS group using
computer-generated random numbers in sealed opaque envelopes. Exclusion criteria will be:
patients weighing more than ±30% of ideal body weight, those with neurological/psychological
disorders, on psychoactive medications, belonging to NYHA class IV, those with severe
stenotic valvular lesions, with known allergy to propofol or any of its constituents, having
severe pulmonary arterial hypertension, with cyanotic congenital heart disease and those who
may require deep hypothermic circulatory arrest for repair. The investigator will be present
during the procedure for data collection purpose only and was not involved in the conduct of
anaesthesia. Patients will be premedicated with oral midazolam syrup 0.25mg/kg 30 minutes
before shifting to operating room. EMLA cream will be applied to the site of venipuncture
for at least one hour. Intravenous access will be obtained in the operating room. Routine
physiological monitoring will be commenced (pulse oximetry, electrocardiography,
non-invasive blood pressure). BIS will be obtained by disposable sensors (Aspect Medical
System Inc. MA USA) attached to the forehead of the patients. The children resisting venous
cannula placement will be excluded from the study and subjected to inhalational induction.
Before induction, patients will receive fentanyl 3µg/kg over three minutes. In automatic
mode, IAADS will calculate and titrate the initial and subsequent propofol infusion rate
according to the weight of the patient, the risk status, the target BIS value which will be
set at 50 for all cases. In manual mode, infusion rate will be determined by the attending
anaesthesiologist according to the weight of the patient and target BIS of 50, with the aim
to maintain BIS within 40-60. After loss of consciousness, patients will receive 0.1mg/kg of
vecuronium bromide and trachea will be intubated after 4 minutes. The lungs will be
ventilated with 100% O2; tidal volume and respiratory rate will be adjusted to maintain an
EtCO2 of 30-35 mm Hg. Central venous catheter and arterial cannula will be inserted
subsequently.
Analgesia will be maintained with infusion of fentanyl at 1µg/kg/hr and additional boluses
of 1µg/kg will be administered before skin incision, sternotomy and commencement of
cardio-pulmonary bypass. Muscle relaxation will be maintained with vecuronium bromide.
Tachycardia and hypertension will be treated with fentanyl bolus, esmolol, nitroglycerine as
appropriate. Hypotension will be treated with fluid bolus, phenylephrine, inotropes as
appropriate. Significant bradycardia will be treated with atropine sulphate. During CPB,
infusion of fentanyl and propofol will be continued. MAP will be maintained between 30-50 mm
Hg and any deviation from these limits will be treated with phenylephrine boluses or
nitroglycerine infusion. Propofol will be administered as per IAADS protocol in automatic
group and manually in control group. The number of times propofol infusion rate that will
needed to be changed in the manual group will be noted.
After skin closure, fentanyl and propofol infusion will be stopped, study protocol will be
terminated and the patients will be shifted to ICU without antagonizing the muscle relaxant
for elective mechanical ventilation. Patients will be given propofol infusion for
postoperative sedation and will be extubated when standard criteria for weaning and
extubation will be met. The children will be subjected to a structured interview as
described by Lopez et a for conscious awareness; on second day after surgery and
approximately one month later.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)
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