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CTRI Number  CTRI/2020/07/026647 [Registered on: 17/07/2020] Trial Registered Prospectively
Last Modified On: 19/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two doses of dexmedetomedine against lignocaine in decreasing the stress response to laryngoscopy and intubation 
Scientific Title of Study   Comparative study between lignocaine and two different doses of dexmedetomidine on the attenuation of hemodynamic stress response in patients posted for elective oncosurgeries 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nevin Philip Mancha 
Designation  Postgraduate 
Affiliation  Kidwai Memorial Institute of Oncology 
Address  Room 105, Department of Anesthesiology and pain relief, Kidwai Memorial Institute of Oncology, Dr M H Marigowda road, Hombegowda nagar, Bengaluru
Room 105, Department of Anesthesiology and pain relief, Kidwai Memorial Institute of Oncology, Dr M H Marigowda road, Hombegowda nagar, Bengaluru
Bangalore
KARNATAKA
560 029
India 
Phone  9655747324  
Fax    
Email  philvin1991@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V B Gowda 
Designation  Professor, Anesthesiology 
Affiliation  Kidwai Memorial Institute of Oncology 
Address  Room 105, Department of Anesthesiology and pain relief, Kidwai Memorial of Institute, Dr M H Marigowda road, Hombegowda nagar, Bengaluru

Bangalore
KARNATAKA
560 029
India 
Phone  9845259264  
Fax    
Email  vbchethana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nevin Philip Mancha 
Designation  Postgraduate 
Affiliation  Kidwai Memorial Institute of Oncology 
Address  Room 105, Department of Anesthesiology and pain relief, Kidwai Memorial of Institute, Dr M H Marigowda road, Hombegowda nagar, Bengaluru

Bangalore
KARNATAKA
560 029
India 
Phone  9655747324  
Fax    
Email  philvin1991@gmail.com  
 
Source of Monetary or Material Support  
Room 105, Department of Anesthesiology and pain relief, Kidwai Memorial Institute of Oncology, Dr M H Marigowda road, Hombegowda nagar, Bengaluru, Bangalore - 560 029 
 
Primary Sponsor  
Name  Kidwai memorial insitute of Oncology 
Address  Room number 105 , Department of Anesthesiology and Pain Relief, Kidwai Memorial institute of Oncology, Dr M H Marigowda Road, Homebgowda Nagar, Bangalore, Karnataka, 560 029 
Type of Sponsor  Research institution and hospital 
 
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 Nevin Philip Mancha  Kidwai Memorial Institute of Oncology  Room number 105, Department of Anesthesiology and Pain relief, Kidwai Memorial institute of oncology, Dr M H Marigowda Road, Hombegowda nagar, Bengaluru, Karnataka 560 029
Bangalore
KARNATAKA 		 9655747324

philvin1991@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, (2) ICD-10 Condition: C50-C50||Malignant neoplasms of breast, (3) ICD-10 Condition: C15-C26||Malignant neoplasms of digestive organs, (4) ICD-10 Condition: C30-C39||Malignant neoplasms of respiratory and intrathoracic organs, (5) ICD-10 Condition: C40-C41||Malignant neoplasms of bone and articular cartilage, (6) ICD-10 Condition: C43-C44||Melanoma and other malignant neoplasms of skin, (7) ICD-10 Condition: C45-C49||Malignant neoplasms of mesothelial and soft tissue, (8) ICD-10 Condition: C51-C58||Malignant neoplasms of female genital organs, (9) ICD-10 Condition: C60-C63||Malignant neoplasms of male genital organs, (10) ICD-10 Condition: C64-C68||Malignant neoplasms of urinary tract, (11) ICD-10 Condition: C69-C72||Malignant neoplasms of eye, brain and other parts of central nervous system, (12) ICD-10 Condition: C73-C75||Malignant neoplasms of thyroid and other endocrine glands, (13) ICD-10 Condition: C76-C80||Malignant neoplasms of ill-defined, other secondary and unspecified sites, (14) ICD-10 Condition: C7A-C7A||Malignant neuroendocrine tumors, (15) ICD-10 Condition: C7B-C7B||Secondary neuroendocrine tumors, (16) ICD-10 Condition: C81-C96||Malignant neoplasms of lymphoid, hematopoietic and related tissue, (17) ICD-10 Condition: D00-D09||In situ neoplasms, (18) ICD-10 Condition: D10-D36||Benign neoplasms, except benign neuroendocrine tumors, (19) ICD-10 Condition: D37-D48||Neoplasms of uncertain behavior, polycythemia vera and myelodysplastic syndromes, (20) ICD-10 Condition: D3A-D3A||Benign neuroendocrine tumors, (21) ICD-10 Condition: D49-D49||Neoplasms of unspecified behavior,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dexmedetomidine 0.5 mcg/kg   Dose: Dexmedetomdine 0.5 mcg/kg diluted in 100 ml Normal saline, Duration: Given over 10 mins as infusion prior to induction Frequency: Bolus infusion( Once only ) Route of administration : Intravenous route  
Intervention  Dexmedetomidine 1 mcg/kg  Dose:Dexmedetomidine 1 mcg/kg diluted in 100 ml Normal saline, Duration:Given over 10 mins as infusion, 10 mins prior to induction, Frequency: Bolus infusion( once only), Route of administration: Intravenous route 
Comparator Agent  Lignocaine 1.5 mg/kg  Dose: Lignocaine 1.5 mg/kg diluted in 10 ml Normal saline, Duration: Bolus dose 3 mins prior to induction Frequency: Bolus dose, Route of administration: Intravenous  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients consenting for study
American society of anesthesiologists (ASA) status 1 and 2
Patients undergoing elective oncosurgeries 
 
ExclusionCriteria 
Details  Patient refusal
History of allergy to study drug
Patients on Calcium channel blockers, beta blockers, ACE inhibitors
Anticipated difficult airway
More than two attempts at intubation
History of Cerebrovascular accident, Ischemic Heart disease, Chronic Obstructive lung disease, Chronic Hypertension
Impaired Renal function tests
Impaired Liver function tests 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
No increase in Heart rate, Systolic blood pressure, Diastolic blood pressure, Mean arterial pressure with the intervention drug as compared to the baseline  Baseline values
Before induction
before intubation
1 min after intubation
3 mins after intubation
5 mins after intubation
10 mins after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
Development of Hypotension and Bradycardia with Study drug  Baseline before study drug administration
Before induction
Before intubation
1 min after induction
3 mins after induction
5 mins after induction
10 mins after induction 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
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   N/A 
Date of First Enrollment (India)   20/07/2020 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Hemodynamic stress response or the Pressor response to laryngoscopy  and intubation is very detrimental in cancer patients as they are weak due to the malignancy itself and due to concurrent treatment like Radiotherapy and chemotherapeutic drugs many of which have major side effects

There is always a need for an agent to overcome this response without any adverse effects

Dexmedetomidine is an alpha 2 adrenoceptor agonist which has the capability to totally blunt the hemodynamic stress response during laryngoscopy and intubation. But, Higher loading doses have known to cause side effects like Bradycardia and Hypotension which maybe counter productive in cancer patients as it leads to other complications that may alter intraoperative management and thereby postoperative recovery.. Hence if lower doses of dexmedetomidine can blunt this hemodynamic response without the side effects of bradycardia and hypotension, it would be of great help in the intraoperative management and early post op recovery of the cancer patient

Lignocaine is a local anesthetic which has been known to reduce the hemodynamic stress response to laryngoscopy and intubation but not blunt it completely. We want to give an active drug instead of a placebo as it may be of some benefit to the already ailing cancer patients.
 
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