Comparison of orally given pregabalin and clonidine in reducing the blood pressure and heart rate response to laryngoscopy and endotracheal intubation in patients undergoing thyroid surgeries

Not yet recruiting

• Conditions: Disorder of thyroid, unspecified,

• Registration Number: CTRI/2020/03/023933
• Lead Sponsor: MOSC Medical College Kolenchery

Brief Summary

Direct laryngoscopy and tracheal intubation are employed as gold standard for conduct of safe general anaesthesia for thyroidectomy  surgeries. But both these procedures are noxious stimuli leading to hemodynamic fluctuations , higher myocardial oxygen demend , increased catecholamines and cardiac arrythmias. This is a concern in all patients particularly in cardiac and cerebrovascular diseases. Several techniques are employed to prevent the hemodynamic responses following laryngoscopy and intubation such as deepening the plain of anesthesia,use of vasodilators, lignocaine, betablockers calcium channel blockers and opiods. All these agents have various side effects.if no specific measures are taken , heart rate can increase from 26 to 66 percentage depending on the method of intubation and systemic blood pressure can increase from 36 to 45 percentage which maybe due to variation in balance between sympathetic and parasympathetic outflow or receptor hypersensitivity. Clonidine posses several properties to make it a valuable premedicant to attenuate the hemodynamic response of laryngoscopy and tracheal intubation. Pregabalin is a voltage gated calcium channel inhibitor with analgesic , anxiolytic and anticonvulsant properties making it a useful oral premedicant. Hence,we are conducting the present double blinded , randomised controlled trial to evaluate the effectiveness of oral pregabalin to clonidine in attenuating hemodynamic changes during direct laryngoscopy and tracheal intubation.

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Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-20
• Last Update Posted: 2020-10-03

Recruitment & Eligibility

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

Inclusion Criteria

ASA I AND II PATIENTS WITH BMI 18 TO 30 UNDERGOING THYROIDECTOMY UNDER GENERAL ANESTHESIA.

Exclusion Criteria

KNOWN ALLERGY TO STUDY DRUGS THYROID WITH RETROSTERNAL EXTENSION PATIENT REFUSAL FOR PARTICIPATION IN THE STUDY PATIENTS ON LONG TERM TREATMENT WITH ANALGESICS SEDATIVES BETA BLOCKERS AND ANTICONVULSANTS PREGNANT WOMEN.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare oral Pregabalin with Clonidine in blunting the pressor response to direct laryngoscopy and endotracheal intubation by monitoring the changes in heart rate and blood pressure	1;3;5;7;10 minutes after intubation

Secondary Outcome Measures

Name	Time	Method
To assess the effect of oral pregabalin and clonidine on preoperative anxiety and sedation using standard scoring systems.
To evaluate the intra operative hemodynamic profile by monitoring heart rate, blood pressure and postoperative analgesia	30 minutes interval for 6 hours after surgery

Trial Locations

Locations (1)

MOSC Medical College Kolenchery; 🇮🇳 Ernakulam, KERALA, India

MOSC Medical College Kolenchery

🇮🇳Ernakulam, KERALA, India

DR SAM PHILLIP

Principal investigator

9447209010

drsam_p@hotmail.com