STUDY OBJECTIVE Primary Objective To study the requirement of propofol
for induction immediately, 5 and 7 mins after fentanyl administration Secondary Objective To compare post induction hemodynamic
changes, incidence of hypotension and fluid bolus requirement To compare the incidence of movement,
vocalization and additional propofol requirement To compare incidence of apnea following
induction STUDY DESIGN - Randomized Clinical Trial INCLUSION
CRITERIA Adult patients aged between 18 and 65 years ASA-I & II physical status Elective procedures under general anaesthesia EXCLUSION
CRITERIA Patient not willing to be in the study group Contraindication to GA ASA-III & IV physical status BMI > 35 kg/m2 Anticipated difficult airway Pregnant patients History of allergy to study drug Drug abuse including chronic alcoholics Emergency procedures METHODOLOGY 1) All the patients will undergo routine pre-operative assessment in the
pre-anaesthetic clinic. 2) Informed written consent will be obtained. 3) Patients will be randomized using a computer‑generated random
numbers into one of the 3 groups 4) Patients will receive the premedication drugs Tab. Ranitidine 150mg
and Tab. Alprazolam 0.5mg, night before surgery and in the morning of surgery. 5) On arrival to the operative room an IV access with 18 or 20 Gauge IV
cannula will be secured. 6) In the operating room, standard preinduction monitors including
electrocardiography, pulse oximetry, and noninvasive blood pressure will be
attached and baseline heart rate and blood pressure will be recorded, followed
by recordings at one‑minute intervals. 7) IV infusion with Ringer’s Lactate will be started at 10 ml/kg/hr and
preoxygenated with 100% of Oxygen (O2) for 3 minutes 8) Fentanyl 2 mcgs/kg TBW will be administered. 9) Group 1 – Patients will be administered with Propofol, immediately
after Fentanyl administration 10) Group 2 – Patients will be administered with Propofol, 5 min after
Fentanyl administration 11) Group 3 – Patients will be administered with Propofol, 7 min after
Fentanyl administration 12) Anaesthesiologist posted in the operating room will inject fentanyl
and the time will be noted 13) An independent anaesthesiologist will be called in to start propofol
injection using infusion pump according to group randomization. 14) The anaesthesiologist who administers propofol will start the
pre-loaded propofol infusion at 300 ml/hr while communicating verbally with the
patient and will note the dose required to produce loss of verbal response. 15) After checking for adequate ventilation, the patients will receive
muscle relaxant – Inj. Atracurium 0.5mg/kg or Inj. Vecuronium 0.1mg/kg body
weight IV. 16) In case of movement or vocalization, additional doses of propofol in aliquots of 20 mg will be
administered and the total dose administered will be noted 17) Incidence of apnea will be recorded 18) Pulse rate (PR), Systolic BP (SBP), Diastolic BP (DBP), Mean
Arterial Pressure (MAP),and SpO2 will be noted every 2 minutes from fentanyl
administration till induction of anaesthesia. 19) In case of hypotension following induction, IV bolus of 300 ml
Ringer’s lactate will be given. 20) Hypotension not responding to fluid bolus will be treated using IV
Phenylephrine 21) Occurrence of hypotension, bradycardia, requirement of fluid
boluses, vasopressors and apnea following induction will be recorded.
END POINT - Loss of verbal response will be the endpoint of
induction following propofol administration |