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
|
|
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
|
|
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. |