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To compare Dexmedetomidine and Fentanyl on effective concentration of Propofol for the insertion of airway device.

Comparision of the Effect Between Dexmedetomidine And Fentanyl on Median Effective Concentration (EC 50) of Propofol for I gel insertion: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/03/018003
Enrollment
90
Registered
2019-03-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N201- Calculus of ureter

Interventions

Intervention1: Group D: Group D - would receive intravenous dexmedetomidine 0.5 mcg/kg over 5 mins prior to induction Control Intervention1: Group F: Group F - would receive intravenous fentanyl 1.5 m

Sponsors

Ankur Luthra
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. American Society of Anesthesiologists physical status I or II 2. Age of 20ââ?¬â??60 years 3. Either gender 4. Estimated operation time of ââ?°Â¤ 2 hours and anaesthesia time of ââ?°Â¤ 3 hours 5. Written informed consent to undergo the therapeutic regimen

Exclusion criteria

Exclusion criteria: 1. Renal dysfunction (serum creatinine > 1.2mg/dl) 2. Liver dysfunction (liver enzymes twice the normal range or higher) 3. History of chronic use of sedatives/ narcotics or analgesics/Beta blockers 4. BMI more than 30 kg/m2 or less than 15 kg/m2 5. Allergy to study medication

Design outcomes

Primary

MeasureTime frame
EC 50 of propofol: The effective concentration of propofol will be recorded in all groups and will be used to calculate the EC50Timepoint: EC 50 of propofol: The effective concentration of propofol will be recorded in all groups just before insertion of I-gel airway and will be used to calculate the EC50

Secondary

MeasureTime frame
Degree of sedation by RASS scaleTimepoint: Every 10 min from arrival in post anaesthesia care unit till discharge;Emergence timeTimepoint: At the end of surgery to eye opening;Haemodynamic indices including Systolic Blood Pressure, Diastolic blood pressure and Mean Arterial Pressure, Heart Rate, Oxygen saturationTimepoint: From preoperative to Discharge every 10 minutes;Intraoperative MAC requirementTimepoint: Every 10 minutes intraoperatiely;Occurrence of any adverse events and duration of stayTimepoint: In Post anaesthesia care unit postoperatively;Time to remove the airway deviceTimepoint: At the end of surgery;Total Propofol requirement for induction in each group Timepoint: After induction

Countries

India

Contacts

Public ContactAnkur Luthra

Post Graduate Institute of Medical Education and Research, Chandigarh

zazzydude979@gmail.com01722756500

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 23, 2026