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CTRI Number  CTRI/2025/02/081425 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 27/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation 
Scientific Title of Study   Effect of Oral Melatonin, Oral Clonidine and Oral Pregabalin Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anurag 
Designation  Post graduate resident 
Affiliation  Sardar Patel Medical College Bikaner Rajasthan India 
Address  Department of Anaesthesia Sardar Patel Medical College Bikaner Rajasthan India

Bikaner
RAJASTHAN
334001
India 
Phone  9460569487  
Fax    
Email  anumbbs13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anita Pareek 
Designation  Addditional Principal and Head of Department 
Affiliation  Sardar Patel Medical College Bikaner Rajasthan India 
Address  Department of Anaesthesia Sardar Patel Medical College Bikaner Rajasthan India

Bikaner
RAJASTHAN
334001
India 
Phone  9828101281  
Fax    
Email  dranitapareek23@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anita Pareek 
Designation  Addditional Principal and Head of Department 
Affiliation  Sardar Patel Medical College Bikaner Rajasthan India 
Address  Department of Anaesthesia Sardar Patel Medical College Bikaner Rajasthan India

Bikaner
RAJASTHAN
334001
India 
Phone  9828101281  
Fax    
Email  dranitapareek23@gmail.com  
 
Source of Monetary or Material Support  
Sardar Patel Medical College Bikaner 334001 Rajasthan India 
 
Primary Sponsor  
Name  Sardar Patel Medical College Bikaner 
Address  Department of Anaesthesia Sardar Patel Medical College Bikaner 334001 Rajasthan India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anurag  Sardar Patel Medical College Bikaner  Department of Anaesthesia OT A BLOCK PBM HOSPITAL Sardar Patel Medical College Bikaner Rajasthan India
Bikaner
RAJASTHAN 
9460569487

anumbbs13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics and Research Board, Sardar Patel Medical College, Bikaner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: C269||Malignant neoplasm of ill-definedsites within the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Direct Laryngoscopy and Tracheal Intubation  Premedication 60 min prior to procedure 
Comparator Agent  Oral Melatonin vs Oral Clonidine vs Oral Pregabalin  Effect of Oral Melatonin 6mg, Oral Clonidine 0.2mg and Oral Pregabalin 150mg Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation ,60 min. prior to procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Elective surgery under general endotracheal anesthesia
 
 
ExclusionCriteria 
Details  1. Anticipated difficult intubation.
2. Modified Mallampati grade III/IV.
3. Patient’s refusal to participate in the study.
4. Patient receiving treatment with either of the study drug i.e., Melatonin or Clonidine; or having any known allergy to these drugs.
5. Patients receiving treatment for any cardiac illness, pregnancy, renal disease, liver disease, morbid obesity, bleeding disorder, thyroid disorder, etc.
6. Patients on anti-hypertensives, oral hypoglycemic, anti-depressants, anti-convulsant, anti-psychotics, thyroid medications, and birth control pills.
7. Pregnant and lactating females.
8. Patients with prolonged laryngoscopy time (more than 30 s)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To Compare Effect of Oral Melatonin, Oral Clonidine and Oral Pregabalin Premedication on Attenuation of Hemodynamic Response to Direct Laryngoscopy and Tracheal Intubation.

Hemodynamic changes like HR, SBP, DBP and MBP 
At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Requirement of intraoperative rescue Propofol doses and need for antihypertensive drug.

Post-operative side effects.

 
Till the drug effect is over 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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)   11/03/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 are essential procedures required in elective case as well as emergency resuscitative settings. It is required to secure patients airway as well as to provide oxygenation and ventilation. Despite being a critical part of anaesthesia, it is still not free from hazard. These two are considered as noxious stimuli. Laryngoscopy alone generates same pressor response as can be seen by laryngoscopy followed by intubation. Hemodynamic stress response from airway instrumentation are due to sympathetic adrenergic response caused by epi pharyngeal and para pharyngeal stimulation leading to significant rise in the catecholamine level. This leads to various responses in various physiological systems of the body such as tachycardia, hypertension, arrhythmia, bronchospasm, increased intracranial pressure, elevation in intraocular pressure, etc. These hemodynamic changes usually peak at 1 to 2 min following laryngoscopy and tracheal intubation, and persist for 5–10 mins. Various methods to attenuate sympathetic response to laryngoscopy and tracheal intubation are being used and research for better drug is going on. All the above mentioned drugs have shown beneficial effects of blunting hemodynamic responses to laryngoscopy and tracheal intubation.

 
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