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CTRI Number  CTRI/2024/05/066906 [Registered on: 07/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Camparision between Dexmedetomidine and Fentanyl in supressing hemodynamic responses during Laryngoscopy and Intubation.  
Scientific Title of Study   Comparison between Dexmedetomidine and Fentanyl in attenuation of hemodynamic responses during Laryngoscopy and Intubation – A Prospective Randomized Controlled Study 
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 G AnilKumar  
Designation  PG student 
Affiliation  District Hospital Bellary 
Address  Department of Anesthesiology District Hospital, Bellary.

Bellary
KARNATAKA
583101
India 
Phone  7330644346  
Fax    
Email  anil.gowni72@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mallanna BP 
Designation  MD Anesthesiology, Senior Consultant and HOD, Department of Anesthesiology 
Affiliation  District Hospital Bellary 
Address  Department of Anesthesiology District Hospital, Bellary

Bellary
KARNATAKA
583101
India 
Phone  9845652555  
Fax    
Email  drmallanna@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mallanna BP 
Designation  MD Anesthesiology, Senior Consultant and HOD, Department of Anesthesiology 
Affiliation  District Hospital Bellary 
Address  Department of Anesthesiology District Hospital, Bellary

Bellary
KARNATAKA
583101
India 
Phone  9845652555  
Fax    
Email  drmallanna@yahoo.com  
 
Source of Monetary or Material Support  
District Hospital Bellary 
 
Primary Sponsor  
Name  G AnilKumar 
Address  Department of Anesthesiology District Hospital Bellary 
Type of Sponsor  Other [DNB Medical Institute] 
 
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 
G AnilKumar  District Hospital Bellary  Department of Anaesthesiology
Bellary
KARNATAKA 
7330644346

anil.gowni72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vijayanagar Institute of Medical Sciences, Ballari INSTITUTIONAL ETHICS COMMITTEE, VIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J039||Acute tonsillitis, unspecified, (2) ICD-10 Condition: H701||Chronic mastoiditis, (3) ICD-10 Condition: J349||Unspecified disorder of nose and nasal sinuses,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DEXMEDETOMIDINE  Patients under trail are given 0.5micrograms/kg of Dexmedetomidine 15minutes before intubation and observing supressor hemodynamic responses of Dexmedetomidine to laryngoscopy and intubation at 1minute, 3minutes, 5minutes, 7minutes and 10 minutes after intubation. 
Comparator Agent  Fentanyl  Patients under trail are given 2 micrograms/kg of Fentanyl 15minutes before intubation and observing supressor hemodynamic responses of Fentanyl to laryngoscopy and intubation at 1minute, 3minutes, 5minutes, 7minutes and 10 minutes after intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)ASA Physical status I and II patients.
2)Weight 50 to 100kg.
3)Airway of Mallampati Grade I and II 
 
ExclusionCriteria 
Details  1)Patients with severe hypertension, ischemic heart disease, arrhythmias, on beta blockers, atrioventricular dysfunction.
2)Pregnants, full stomach patients and emergency surgeries.
3)Patients in which duration of laryngoscopy took greater than 30seconds. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
camparing changes in Heart Rate.  Compare which among these drugs Dexmedetomidine 0.5mcg/kg and Fentanyl 2mcg/kg in attenuating stress response like Heart Rate to laryngoscopy and endotracheal intubation is best. 
 
Secondary Outcome  
Outcome  TimePoints 
1)Changes in Other hemodynamic parameters like SBP, DBP, MAP, SPO2 during the process
2)To look for any adverse effects during the interventions. 
1)Changes in Other hemodynamic parameters like SBP, DBP, MAP, SPO2 at 1minute, 3minutes, 5minutes, 7minutes & 10 minutes after intubation
2)To look for any adverse effects during the interventions 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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 3/ Phase 4 
Date of First Enrollment (India)   14/05/2024 
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 Applicable 
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   Title “Comparison between Dexmedetomidine and Fentanyl in attenuation of hemodynamic response during Laryngoscopy and Intubation – A Prospective Randomized Controlled Study”. 
Need for Study
 Introduction 
 Endotracheal intubation is an important procedure practiced in the field of anesthesia. Laryngoscopy and endotracheal intubation increase the plasma concentration of catecholamines due to sympathetic stimulation which can result in tachycardia and hypertension in most of the individuals1 . Due to imbalance in oxygen demand and supply to the heart, this stress response can be detrimental to an extent leading to myocardial infarction, pulmonary oedema, arrhythmias, cerebrovascular accidents such as hemorrhage and other complications in susceptible patients. Various drug regimens and techniques have been used from time to time for attenuating the stress response to laryngoscopy and intubation, including opioids, barbiturates, benzodiazepines, beta blockers, calcium channel blockers, vasodilators, etc2 . Traditionally used drugs like lignocaine, fentanyl, esmolol etc. are either not fully effective or may results in considerable adverse effects3 . Dexmedetomidine and Fentanyl are studied and known to decrease the hemodynamic response during intubation in various doses. There have been little investigations in comparing the efficacy of Dexmedetomidine and Fentanyl in attenuating hemodynamic response during intubation and also different studies yielded conflicting results. So the current study may fill the lacunae in research to find out which one is best among these drugs in attenuating hemodynamic responses during laryngoscopy and intubation.
Design of study :- Prospective, Comparative and Randomized Controlled Study. Grouping & details of grouping:-  Patients will be randomly grouped into two groups of 33 each. Group D - 0.5mcg/kg of Dexmedetomidine Group F - 2mcg/kg of Fentanyl. Study Period: 1-7-2023 to 30-6-2024
Procedure/ Technique After clinical approval of institutional ethical committee and taking informed and written consent, the sample size is calculated using COHEN’S – D method. All patients selected based on the inclusion criteria under study will undergo preanesthetic evaluation including detailed history, clinical examination and appropriate investigations depending on age, sex and disease of the patient. Patients will be randomly grouped into three groups of 36 each. Group (D) will receive 0.5mcg/kg of Dexmedetomidine diluted to 10ml with normal saline, Group (F) will receive 2mcg/kg of Fentanyl diluted to 10ml with normal saline, and Group (M) will receive 30mg/kg of Magnesium sulfate diluted to 10ml with normal saline, over 10 minutes intravenously. All patients will be assessed serially for the following parameters like Heart Rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP), Saturation of Peripheral Oxygen (SPO2) at 1, 3 and 5 minutes. After preoxygenation for 3 minutes, IV Propofol 2mg/kg is used as an induction agent and neuromuscular block is achieved with Vecuronium 0.1mg/kg. Oxygenation and depth of anesthesia were maintained by mask ventilation with 100% Oxygen and Isoflurane to maintain a minimum alveolar concentration of 1 through anesthesia work station. Intubation done and confirmation of its position done by auscultation and capnography. The patient is put on the volume control mode on a ventilator to maintain EtCO2 of 30-35 mmHg. At 1 min, 3 min, 5 min, 7 min and 10 min after laryngoscopy and intubation, hemodynamic parameters are recorded. Any fall in SBP to < 20% of basal levels is planned to treat with IV Mephentermine 3 to 6 mg and bradycardia with HR < 60 beats/min with IV atropine 0.6mg. No form of stimulus is given during this period. Analgesics such as Paracetamol, Pentazocine and Morphine are given to all three groups after 10min. The surgery commences after 10 min of intubation. Patients are extubated at the end of surgery. Sample size: Sample size for the study is determined by using COHEN’S – D method for paired Comparison between Dexmedetomidine and Fentanyl in attenuation of Heart Rate during Laryngoscopy and Intubation before and after drug administration.
Primary Objective:- Compare which among these drugs Dexmedetomidine 0.5mcg/kg and Fentanyl 2mcg/kg in attenuating stress response like Heart Rate to laryngoscopy and endotracheal intubation is best. Secondary Objective:- Other hemodynamic parameters like SBP, DBP, MAP, SPO2.  To look for any adverse effects during the interventions.
 
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