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to compare the effect of fentanyl in heamodymanic changes during laryngoscopy and intubation(general anaesthesia) in normotensive vs hypertensive patient

â??Clinical evaluation of efficacy and safety of 3 µg/kg Fentanyl to prevent haemodynamic stress response during laryngoscopy and intubarion in normotensive v/s hypertensive population: A prospective, double blind clinical study.â??

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/07/009103
Enrollment
100
Registered
2017-07-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- patient under going surgery which requires general anasthesia

Interventions

Intervention1: 3 µg/kg fentanyl during laryngoscopy and intubation in hypertensive population: 3 µg/kg fentanyl 5 minute before to laryngoscopy and intubation in hypertensive population to prevent

Sponsors

Department of Anaesthesiology Sir T Hospital Bhavnagar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: NORMOTENSIVE PATIENT: 1 Age:20 to 50 years 2 Gender: Male and Female 3 ASA physical status I and II 4 Patient posted for elective surgery under general anaesthesia requiring endotracheal intubation 5 Surgery duration less than two hours 6 BMI 7 Informed written consent for participation in study. 8 Modified Mallampatti Classification I and II HYPERTENSIVE PATIENT: 1 Age:20 to 50 years 2 Gender: Male and Female 3 ASA physical status II(well controlled primary Idiopathic hypertension (blood pressure medications excluding β blocker) No end organ involvement due to hypertension. 4 Patient posted for elective surgery under general anaesthesia requiring endotracheal intubation 5 Surgery duration less than two hours 6 BMI 7 Informed written consent for participation in study. 8 Modified Mallampatti Classification I and II

Exclusion criteria

Exclusion criteria: 1 Patient refusing consent 2 Patient with Diabetes ,COPD, Renal disease, Cardiac diseases like IHD, Valvular heart disease, AV conduction block, LVF & Psychiatric illness etc. 3 Patient on drugs likes sedatives, opioids, anti-psychiatrics and β blockers. 4 ASA physical status III and above. 5 Anticipated difficult intubation. 6 BMI 25>=kg/m2 7 Intubation attempt lasting more than 20seconds 8 Patient on more than 3 antihypertensive medications. 9 Defaulter of taking antihypertensive medication as per schedule

Design outcomes

Primary

MeasureTime frame
To assess the efficacy and safety of fentanyl in attenuating hemodynamic stress response to laryngoscopy and endotracheal intubation in normotensive v/s controlled hypertensive patients in respect to following parameters: 1. Heart Rate (HR) 2. Systolic Blood Pressure (SBP) 3. Diastolic Blood Pressure (DBP) 4. Mean Arterial Pressure (MAP) 5. Change in cardiac rhythmTimepoint: base line-15 minute after premedication-5 minute after fentanyl-during laryngoscopy and intubation-after intubation(1,3,5,10,15,20,30,45,60,90,120 minute)-at the time of extubation-after extubation

Secondary

MeasureTime frame
-To assess the sedative effect of fentanyl. -To observe complication if any in both groups. Timepoint: base line-15 minute after premedication-5 minute after fentanyl-during laryngoscopy and intubation-after intubation(1,3,5,10,15,20,30,45,60,90,120 minute)-at the time of extubation-after extubation

Countries

India

Contacts

Public ContactDr DC Tripathi

Govt. Medical College, Bhavnagar.

drtripathi1961@yahoo.co.in9428408718

Outcome results

None listed

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