To compare the heart rate and blood pressure changes during start of anaesthesia by giving two different drugs orally clonidine and tizanidine before the surgery

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/09/057959
• Lead Sponsor: Ananta Institute Of Medical Science And Research Centre

Brief Summary

Laryngoscopy and endotracheal intubation causes a rise in heart rate and blood pressure.  Tizanidine is an imidazoline derivative and a centrally acting alpha-2 receptor agonist.  Administration of Tizanidine  result in hemodynamic stability and decrease the myocardial ischemia.  It attains the steady-state concentration within 24 to 48 hours after administration.  Clonidine is an antihypertensive medication that acts on alpha-adrenergic and imidazoline receptor agonists.   A 100µg oral clonidine tablet reaches a steady state in  around 60 minutes and has a bioavailability of 55-87%. In this study we are comparing oral Tizanidine and oral Clonidine on attenuation of haemodynamic response to laryngoscopy in patients undergoing spine surgery.  

METODOLOGY: A prospective randomised double blind study will be carried out on 82 (ASA I AND II) patients aged,18-60 years,scheduled for elective spine surgery under general anaesthesia.Group T,patients will receive oral Tizanidine 4 mg and Group C,patients will receive oral Clonidine 100 mcg 1 hour before the induction of anaesthesia. Haemodynamic response will be monitered 1,3,5,7,10, then every 10 min till 30 min and then every 15 min till 1 hour and then every 30 min till end of surgery.Postoperatively pain and sedation score will be accessed at every 1 hours till 2 hours, then at 6 hours and then every 6 hours toll 24 hour after the end of surgery



Objectives: The primary objective of the study is to compare the effects of oral Clonidine versus oral Tizanidine on haemodynamic response to laryngoscopy in patients undergoing Spine Surgery. Secondary objectives are duration of analgesia, severity of pain as assessed by visual analogue score (VAS)and sedation score as assessed by Ramsay sedation score(RSS)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-10
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patients scheduled for spine surgery under general anaesthesia.
• Belonging to ASA (American Society of Anaesthesiology) class I, II.

Exclusion Criteria

• History of cardiovascular diseases e.g. Ischemic heart disease, conduction defects, etc.
• BMI <20 and >30 Uncontrolled hypertension and Diabetes Pregnant or lactating women.
• Drug allergy.
• Surgical complications (bleeding, dura puncture,nerve, vessel or organ injury) Surgery duration >3 hours.
• Patient’s baseline heart rate <60 bpm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the the haemodynamic response to laryngoscopy and endotracheal intubation in two groups including heart rate(HR),systolic blood pressure(SBP),diastolic blood pressure(DBP),mean arterial pressure(MAP)	values of Heart rate and blood pressure will be recorded preoperatively, and 1,3,5,7,10 min then every 10 min till 30 min after laryngoscopy.

Secondary Outcome Measures

Name	Time	Method
To compare severity of pain in 2 groups using Visual analogue score(VAS) for 24 hours	visual analouge score at 1,2,6,12,18,24 hours.
To compare post-operative Ramsay sedation score (RSS) in 2 groups
Time of administration of first rescue analgesic.	visual analouge score at 1,2,6,12,18,24 hours.

Trial Locations

Locations (1)

Ananta institute of medical science and research centre; 🇮🇳 Rajsamand, RAJASTHAN, India

Ananta institute of medical science and research centre

🇮🇳Rajsamand, RAJASTHAN, India

Dr Sakshi Thakore

Principal investigator

9571241824

drsakshiarora88@gmail.com