| CTRI Number |
CTRI/2023/09/057959 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
21/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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 |
|
Scientific Title of Study
|
Comparative evaluation on effect of oral Tizanidine versus oral Clonidine on attenuation of haemodynamic response to laryngoscopy in patients undergoing spine surgery : A prospective randomized double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rishabh Verma |
| Designation |
PG JR1 |
| Affiliation |
Ananta Institute Of Medical Science And Research Centre |
| Address |
room no-2041, second floor, OT complex, Department of Anaesthesia, Ananta institute of medical science and research centre, Rajsamand, 313202
room no-2041, second floor, OT complex, Department of Anaesthesia, Ananta institute of medical science and research centre, Rajsamand, 313202
Rajsamand
RAJASTHAN
313202
India |
| Phone |
8871401020 |
| Fax |
|
| Email |
rv10041997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sakshi Thakore |
| Designation |
Assistant Professor |
| Affiliation |
Ananta Institute Of Medical Science And Research Centre |
| Address |
room no-2041, second floor, OT complex, Department of Anaesthesia, Ananta institute of medical science and research centre, Rajsamand, 313202
room no-2041, second floor, OT complex, Department of Anaesthesia, Ananta institute of medical science and research centre, Rajsamand, 313202
Rajsamand
RAJASTHAN
313202
India |
| Phone |
9571241824 |
| Fax |
|
| Email |
drsakshiarora88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Thakore |
| Designation |
Assistant Professor |
| Affiliation |
Ananta Institute Of Medical Science And Research Centre |
| Address |
room no-2041, second floor, OT complex, Department of Anaesthesia, Ananta institute of medical science and research centre, Rajsamand, 313202
room no-2041, second floor, OT complex, Department of Anaesthesia, Ananta institute of medical science and research centre, Rajsamand, 313202
Rajsamand
RAJASTHAN
313202
India |
| Phone |
9571241824 |
| Fax |
|
| Email |
drsakshiarora88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ananta Institute Of Medical Science And Research Centre, NH-8, Nathdwara, Dist-Rajsamand (313202) |
|
|
Primary Sponsor
|
| Name |
Ananta Institute Of Medical Science And Research Centre |
| Address |
Ananta institute of medical science and research centre,Rajsamand |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sakshi Thakore |
Ananta institute of medical science and research centre |
Room no-2041, second floor, Department of Anaesthesia, OT complex, Ananta institute of medical science and research centre, Rajsamand
Rajsamand
RAJASTHAN |
9571241824
drsakshiarora88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIMSRC-Institutional Ethical committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oral Clonidine |
tab.Clonidine 100mcg,orally single dose, one hour before the induction of anaesthesia with a sip of water. Patient will be followed intraoperatively and postopretively 6 hourly for 24 hours. |
| Intervention |
oral Tizanidine |
tab. Tizanidine 4mg, orally single dose, one hour before the induction of anaesthesia with a sip of water. Patient will be followed intraoperatively and postopretively 6 hourly for 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for spine surgery under general anaesthesia.
Belonging to ASA (American Society of Anaesthesiology) class I, II |
|
| ExclusionCriteria |
| Details |
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
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Time of administration of first rescue analgesic. |
visual analouge score at 1,2,6,12,18,24 hours. |
| 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
|
Ramsay sedation score at 1,2,6,12,18,24 hours |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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) |