Authors
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Dr Chetan Dessai -More
Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2026
INTERVENTION: Intervention1: Target Controlled Infusion of Propofol: Propofol administered via TCI pump using the Eleveld pharmacokinetic model, targeting an effect‐site concentration of 4 mcg/ml for induction of general anaesthesia Control Intervention1: Bolus Propofol: Propofol administered as a manual bolus injection at 2 mg/kg body weight, given over 15 20 seconds for induction of general anaesthesia CONDITION: Health Condition 1: H712‐ Cholesteatoma of mastoid Health Condition 2: H728‐ Other perforations of tympanic membrane Health Condition 3: K402‐ Bilateral inguinal hernia, withoutobstruction or gangrene Health Condition 4: K429‐ Umbilical hernia without obstruction or gangrene Health Condition 5: K801‐ Calculus of gallbladder with othercholecystitis Health Condition 6: N602‐ Fibroadenosis of breast Health Condition 7: N925‐ Other specified irregular menstruation Health Condition 8: N800‐ Endometriosis of uterus Health Condition 9: N850‐ Endometrial hyperplasia Health Condition 10: N200‐ Calculus of kidney Health Condition 11: N819‐ Female genital prolapse, unspecified PRIMARY OUTCOME: To compare Mean Arterial Pressure between two groups at t0, t3, t5, t7 and tx.Timepoint: t0 is baseline, pre‐induction, t3 is 3 min after fentanyl, just before propofol, t5 is 2 min after propofol, t7 is 4 min after propofol, tx is immediately after intubation SECONDARY OUTCOME: To compare BIS between two groups at t0, t3, t5, t7 & txTimepoint: t0 is baseline, pre‐induction, t3 is 3 min after fentanyl, just before propofol, t5 is 2 min after propofol, t7 is 4 min after propofol, t Xis immediately after intubation To compare diastolic BP between two groups at t0, t3, t5, t7 & txTimepoint: t0 is baseline, pre‐induction, t3 is 3 min after fentanyl, just before propofol, t5 is 2 min after propofol, t7 is 4 min after propofol, t Xis immediately after intubation To compare heart rate between two groups at t0, t3, t5, t7 & tx.Timepoint: t0 is baseline, pre‐induction, t3 is 3 min after fentanyl, just before propofol, t5 is 2 min after propofol, t7 is 4 min after propofol, t Xis immediately after intubation To compare SpO2 between two groups at t0, t3, t5, t7 & txTimepoint: t0 is baseline, pre‐induction, t3 is 3 min after fentanyl, just before propofol, t5 is 2 min after propofol, t7 is 4 min after propofol, t Xis immediately after intubation To compare systolic BP between two groups at t0, t3, t5, t7 & txTimepoint: t0 is baseline, pre‐induction, t3 is 3 min after fentanyl, just before propofol, t5 is 2 min after propofol, t7 is 4 min after propofol, t Xis immediately after intubation To compare time required for loss of eyelash refle Xbetween both groups.Timepoint: Time interwal from t3 which is strting propofol in both groups till eyelash refle Xis lost. To compare total propofol consumption during induction.Timepoint: Calculated before indunction based on body weight for Bolus group & for TCI group it is noted from the total drug delivered by TCI during induction INCLUSION CRITERIA: 1. Age 18 to 65 years 2. ASA status I or II 3. BMI 18 to 30 4. Willingness to participate in study
Epistemonikos ID: 7e8071c66be27ddde9b35e6ccd918fd88f4c2d62
First added on: Oct 08, 2026