COMPARING EFFICACY OF TWO DIFFERENT DOSES OF FENTANYL FOR PREVENTING HYPERTENSION AND TACHYCARDIA WHILE GIVING GENERAL AENESTHESIA

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/03/031837
• Lead Sponsor: Government of Gujarat

Brief Summary

- Laryngoscopy prior to intubation and intubation in itself produce significant hemodynamic stress response in the form of tachycardia and hypertensionwhich is usually transient, returns to base line within 10-15 minutes and well tolerated by healthy individuals without cardio-respiratory compromise but can prove disastrous in the patient with cardiac and neurological diseases.

- Among opioids, fentanyl citrate has been identified as a most effective agent for this purpose. Fentanyl is effective in blunting  stress response to intubation and has been used for this purpose in different doses titrationranging from 1.5µg/kg to 6µg/kg in different studies.

- In most of the studies, investigators assessed response of fentanyl in normotensive population to prevent hemodynamic stress response to intubation. Their findings cannot be applied to the hypertensive population which behave quite differently than normotensive group.

- This prompted us to plan the present study to evaluate the efficacy and safety of two different doses of fentanyl (2µg and 3µg) to prevent hemodynamic stress response to laryngoscopy and intubation in controlled hypertensive patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-15
• Last Update Posted: 2021-04-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Informed written consent.
• Patients posted for elective surgery under general Anesthesia requiring endotracheal intubation.
• ASA physical status || Well controlled primary idiopathic hypertension(blood pressure less then or equal to 140/90) with maximum three anti hypertensive medications excluding beta blockers.
• No end organ involvement due to hypertension.
• BMI less then or equal to 25.
• Modified Mallampati classification | and ||.

Exclusion Criteria

• Patient refusing for consent.
• Patients with diabetes, COPD, renal disease, cardiac diseases like IHD, valvular heart disease, AV conduction block, aortic stenosis, left ventricular failure etc.
• Patient on drugs(sedatives,opioids,anti-psychotic drugs and beta blockers).
• Anticipated difficult intubation.
• BMI more then or equal to 25.
• Intubation attempt lasting longer than 15 seconds.
• Patient on more than 3 anti hypertensive medications.
• Defaulter of taking anti hypertensive medications as per schedule.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Variation in heart rate, systolic blood pressure, diastolic blood pressure, ST-T changes, cardiac rhythm changes	From injection of intravenous fentanyl to 20 minutes after endotracheal intubation

Secondary Outcome Measures

Name	Time	Method
To asses sedative effect of fentanyl and to observe any complications	From injection of intravenous fentanyl to 60 minutes after endotracheal extubation

Trial Locations

Locations (1)

Civil hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Civil hospital

🇮🇳Ahmadabad, GUJARAT, India

DR DHANANJAY BARAIYA

Principal investigator

9574775664

ddbaraiya5664@gmail.com