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Effect of two different dose of Fentanyl to decrease adverse effect of intubation

Comparative study of two different doses of Injection Fentanyl citrate 2 µg/kg and 4 µg/kg Intravenous in attenuation of hemodynamic responses during intubation - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/06/069395
Enrollment
50
Registered
2024-06-24
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Inj. Fentanyl 4 microgram/kg iv before intubation: To assess the efficacy and safety of 4 µg /kg of Inj.Fentanyl iv as premedication before 5 minutes in attenuating hemodynamic stress

Sponsors

Goverment of Gujarat
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients posted for elective surgery under general anaesthesia requiring endotracheal intubation. ASA physical status I and II BMI :18-30 kg/m2. Modified Mallampatti classification I & II

Exclusion criteria

Exclusion criteria: Patient refusing for consent. Patients with Diabetes, COPD, Renal disease, Valvular heart disease, AV conduction block, Aortic stenosis, Left ventricular failure etc. Patients on Medications (sedatives, opioids, anti-psychiatric drugs and ß blocker) Anticipated difficult intubation BMI =30kg/m2 Intubation attempt lasting longer than 20 seconds

Design outcomes

Primary

MeasureTime frame
Parameters compared will be: Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP)Timepoint: Time frame will be Baseline measures , at the time of premedication , after induction , after laryngoscopy and intubation, 1 mins, 3 mins, 5 mins and 10 mins.

Secondary

MeasureTime frame
(1) Intra operative : HR, SBP, DBP, MAP Timepoint: Time frame will be 20 mins , 30 mins, 40 mins , 50 mins, 60 mins;(2) Post operative complications: Sedation, Respiratory depression, chest wall rigidity, Bradycardia, Hypotension, Pruritus, Nausea, VomitingTimepoint: Time frame will be 20 mins , 30 mins, 40 mins , 50 mins, 60 mins

Countries

India

Contacts

Public ContactDr Shakuntala J Goswami

B.J.Medical College and Civil Hospital Ahmedabad

dhrumit09@yahoo.com9327021192

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026