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CTRI Number  CTRI/2024/12/078117 [Registered on: 16/12/2024] Trial Registered Prospectively
Last Modified On: 16/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective 
Study Design  Other 
Public Title of Study   A study to compare how well dexmedetomidine reduces changes in blood pressure and heart rate when given in two different doses intramuscularly during administration of general anaesthesia with endotracheal tube 
Scientific Title of Study   A prospective study to compare the efficacy of two different doses of intramuscular dexmedetomidine in attenuating 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  Milloni Shah 
Designation  Resident doctor 
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
391760
India 
Phone  9930241415  
Fax    
Email  millonishah17@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sara Mary Thomas 
Designation  Head of Department and Professor 
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
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sara Mary Thomas 
Designation  Head of Department and Professor 
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
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, Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760  
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 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 Milloni Shah  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
Vadodara
GUJARAT 
09930241415

millonishah17@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 
Comparator Agent  Intramuscularly dexmedetomidine 1 mcg/kg  Inj. Dexmedetomidine 1mcg/kg intramuscular 60 minutes prior to induction of general anaesthesia 
Intervention  Intramuscularly dexmedetomidine 1.5mcg/kg   Inj. Dexmedetomidine 1.5mcg/kg intramuscular 60 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 (ASA) 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 ≥ 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 response during laryngoscopy and intubation in two different doses via intramuscular route.  baseline
after test drug administration at 15 minutes, 30 minutes, 45 minutes and one hour
after induction
at laryngoscopy and intubation
1 min after intubation
3 mins after intubation
5 minutes after intubation
7 minutes after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To study sedation score or any other side effects  post-operatively sedation status will be assessed every 30 minutes by RAMSAY sedation score till a score of less than or equal to 3 will be achieved.  
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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)   27/12/2024 
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)
Modification(s)  
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 the efficacy of two different doses of intramuscular dexmedetomidine in attenuating the hemodynamic responses during laryngoscopy and endotracheal intubation.

 

Aim:

To compare the efficacy of two different doses of intramuscular Dexmedetomidine on attenuation of hemodynamic responses to laryngoscopy and endotracheal intubation in patients undergoing general anaesthesia.

 

Objective:

To compare the efficacy in attenuating heart rate during laryngoscopy and endotracheal intubation.

To compare the efficacy in attenuating blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure) during laryngoscopy and endotracheal intubation.

To compare post operative sedation between the study groups by RAMSAY Sedation Score.

 

Group A: patients will receive inj. Dexmedetomidine 1mcg/kg intramuscularly 60 minutes prior to induction of anesthesia.

Group B patients will receive inj. Dexmedetomidine 1.5mcg/kg intramuscularly 60 minutes prior to induction of anesthesia 

Drug 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 i.m injection of test drug till induction, after giving inducing agents, during laryngoscopy and intubation and at 1,3,5 & 7 minutes after intubation.

 

Post-operatively, sedation status will be assessed half hourly by RAMSAY Sedation Score (RSS) till a score of ≤ 3 is achieved.

 

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 ≥ 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.

 

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

 

Study Design- Prospective, Observational and Comparative Study

 

 

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

 

Statistical analysis:

Numerical variables will be presented as mean & standard deviation (SD) while categorical variables will be presented as frequency and percentage. 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; chi–square test will be used. p value <0.05 will be considered statistically significant.

 

Likely outcome/ Benefits of the study:

This prospective and observational study will help us to compare the efficacy between two different doses of intramuscular Dexmedetomidine in attenuating hemodynamic responses to laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia 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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