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CTRI Number  CTRI/2025/02/080072 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 28/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare how well dexmedetomidine reduces the changes in blood pressure and heart rate when given intravenously in two different doses during administration of general anaesthesia with endotracheal tube.  
Scientific Title of Study   A Prospective study to compare the efficacy to compare the efficacy of two different doses of intravenous Dexmedetomidine in attenuating the hemodynamic responses during laryngoscopy and endotracheal 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  Harsh Chandreshbhai Rathod 
Designation  PG resident 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department General OT Complex 2nd floor Dhiraj Hospital Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre Waghodia Piparia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9429317676  
Fax    
Email  rathodharsh2310@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sara Mary Thomas 
Designation  Professor and Head of Department 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department General OT Complex 2nd floor Dhiraj Hospital Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre Waghodia Piparia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sara Mary Thomas 
Designation  Professor and Head of Department 
Affiliation  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Anaesthesia Department General OT Complex 2nd floor Dhiraj Hospital Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre Waghodia Piparia Vadodara Gujarat

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Source of Monetary or Material Support  
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodia, Piparia, Vadodara, Gujarat, India, 391760 
 
Primary Sponsor  
Name  Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Waghodia, Piparia, Vadodara, Gujarat, India, 391760 
Type of Sponsor  Private 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 Harsh Rathod  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre  2nd Floor,General ot complex,Anesthesia Department,Dhiraj hospital,Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre ,Sumandeep vidyapeeth Wagodhia , Pipariya, Vadodara GUJARAT 391760 India
Vadodara
GUJARAT 
9429317676

rathodharsh2310@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous infusion of Demedetomidine 1mcg/kg  Inj. Dexmedetomidine 1mcg/kg intravenously as an infusion in 100ml Normal Saline 30 minutes prior to induction of general anaesthesia. 
Comparator Agent  Intravenous infusion of Dexmedetomidine 1.5mcg/kg  e Inj. Dexmedetomidine 1.5mcg/kg intravenously as an infusion in100ml Normal Saline 30 minutes prior to induction of general anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to sign informed consent
Male or female patients between 18 to 60 years of age
Patients belonging to American Society of Anesthesiologists physical status I and II
Patients posted for elective surgeries under general anaesthesia
 
 
ExclusionCriteria 
Details  Patients unwilling to participate in the study
Patients with Body Mass Index more than 30 kg/m2
Patients with history of muscular disorder myositis or any local infection
Patients with cardiovascular diseases arrhythmias heart blocks or taking beta blockers
Patients with cerebrovascular, hepatic and renal diseases.
Psychiatric patients.
Patients with history of allergy to an α-2 adrenergic agonist
Pregnancy & lactating women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
to check efficacy of dexmedetomidine for blunting hemodynamic resonse during laryngoscopy and intubation via intravenous route in two different doses  baseline
every 15 minutes after administrating drug
at induction
at laryngoscopy
at 3 mins
at 5 mins
at 7 mins 
 
Secondary Outcome  
Outcome  TimePoints 
to study sedation status post operatively  post operatively sedation status will be assessed every 30 minutes for 3 hours by RAMSAY sedation score 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   28/02/2025 
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)   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   A prospective study to compare to compare the efficacy of two different doses of intravenous dexmedetomidine in attenuating hemodynamic responses during laryngoscopy and endotracheal intubation. 

AIM
 To compare the efficacy of two different doses of intravenous Dexmedetomidine on attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation inpatients undergoing general anaesthesia.

Objective 
1. To compare the efficacy in attenuating heart rate during laryngoscopy and endotracheal intubation. 
2. To compare the efficacy in attenuating blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure) during laryngoscopy and endotracheal intubation. 
3. To compare post operative sedation between the study groups by RAMSAY Sedation Score.

Inclusion Criteria 
Patients willing to sign informed consent.  Male or female patients between 18 to 60 years of age. 
Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II. 
Patients posted for elective surgeries under general anaesthesia.

Exclusion Criteria:
 Patients unwilling to participate in the study. 
 Patients with Body Mass Index more than 30 kg/m2 . 
Patients with history of muscular disorder myositis or any local infection 
Patients with cardiovascular diseases, arrhythmias, heart blocks, or taking betablockers. 
 Patients with cerebrovascular, hepatic and renal diseases. 
Psychiatric patients. 
 Patients with history of allergy to an α-2 adrenergic agonist 
Pregnancy & lactating women.

We will be conducting this study on 30 adults aged 18-60 years belonging to grade I & II of American Society of Anesthesiologists (ASA) classification who will undergo elective surgeries under general anaesthesia. They will be randomly allocated using computer generated random numbers into 2 groups Group A and Group B of 15 patients each: 
 Group A: patients will receive Inj. Dexmedetomidine 1mcg/kg intravenously as an infusion in 100ml Normal Saline 30 minutes prior to induction of general anaesthesia. 
Group B: patients will receive Inj. Dexmedetomidine 1.5mcg/kg intravenously as an infusion in 100ml Normal Saline 30 minutes prior to induction of general anaesthesia. 
Drugs will be administered by the consultant Anesthesiologist present in the operation theatre.

Monitoring of parameters i.e.HR, SBP, DBP, MAP, SPO2 will be noted at baseline, every 15 mins after intravenous injection of test drug till induction, after giving inducing agents, during laryngoscopy and intubation and at 1,3,5 & 7 minutes after intubation.

Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Instituteand Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Design- Prospective Observational Study 

Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee for duration of 18 months. 

SAMPLE SIZE : 60  patients 

Data will be collected & tabulated. Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency andpercentage. As regard to numerical variables; tests like unpaired student “t test and/or ANNOVA will be used whenever appropriate for between-groups comparisons, while for categorical variables; chii“square test will be used. p value <0.05 will be considered statistically significant.

Likely outcome/ Benefit of the study:
This prospective and observational study will help us to compare the efficacy between two different doses of intravenous Dexmedetomidine in attenuating hemodynamic responses to laryngoscopyand endotracheal intubation inpatients undergoing surgeries under generalanaesthesia and will enable us to know which dose of the dexmedetomidine drug is most beneficial in giving balanced general anaesthesia by having better outcomes in hemodynamics.  
 
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