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Finding the Appropriate Dose of drug Fentanyl to Reduce Changes in Heart Rate and Blood Pressure During Breathing Tube Insertion in Smokers With and Without High Blood Pressure.

Determination of ED90 and ED50 dose of Fentanyl for the Attenuation of Intubation Response in Smokers with and without Hypertension: A Biased coin up- and down Sequential Allocation Study - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105953
Enrollment
80
Registered
2026-03-11
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: -

Interventions

Intervention1: To determine the ED90 and ED50 of intravenous fentanyl for blunting the hemodynamic response (heart rate and mean arterial pressure) to laryngoscopy and intubation in smokers with and

Sponsors

Jawaharlal Institute of Postgraduate Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Elective surgery Age 18 years to 60 years Current smokers Controlled hypertension (For Group A) The American society of Anesthesiologists [ASA] Physical status I, II.

Exclusion criteria

Exclusion criteria: Ischemic Heart disease, Valvular heart disease , Arrhythmias Anticipated difficult airway Known autonomic neuropathy Patients on beta blockers BMI more than or equal to 35kg per m2 History of opioid use

Design outcomes

Primary

MeasureTime frame
To determine the ED90 and ED50 of intravenous fentanyl for blunting the hemodynamic response (heart rate and mean arterial pressure) to laryngoscopy and intubation in smokers with and without hypertension designed as group A and group B respectively.Timepoint: Mean arterial pressure and heart rate will be recorded at predefined time points. Baseline values will be taken as the average of two readings recorded at 1 minute and 2.5 minutes after arrival in the operating room. Measurements will also be recorded after fentanyl administration at 1 and 2 minutes, immediately before laryngoscopy, and after intubation at 1, 2 minutes.

Secondary

MeasureTime frame
To compare hemodynamic parameters during intubation between hypertensive & non hypertensive smokers. Timepoint: Hemodynamic parameters such as SBP,DBP,MAP,HR,SpO2 are recorded after fentanyl administration at 1 & 2 minutes, immediately before laryngoscopy & after intubation at 1, 2,5,10 minutes. ;To compare the incidence of adverse events as Arrhythmia, bradycardia, hypotension, desaturation, cough, bronchospasm during induction between the groups.Timepoint: Adverse events will be monitored from the time of fentanyl administration & subsequent intubation until the time of surgical incision.

Countries

India

Contacts

Public ContactDr Bavanash B

Jawaharlal institute of postgraduate medical education and research,puducherry

vishnu.narayanan.1993@gmail.com8547442182

Outcome results

None listed

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