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CTRI Number  CTRI/2025/02/080067 [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, Active Controlled Trial 
Public Title of Study   A study to compare how well intravenous dexmedetomidine and intravenous preservative free lignocaine reduces changes in blood pressure and heart rate during administration of general administration with endotracheal tube  
Scientific Title of Study   A study to compare intravenous dexmedetomodine with intravenous preservative free lignocaine for attenuation of hemodynamic responses to 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 Rathod 
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 Sumandeep Vidyapeeth Waghodia Pipariya Gujarat India 391760

Vadodara
GUJARAT
391760
India 
Phone  9429317676  
Fax    
Email  rathodharsh2310@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 Sumandeep Vidyapeeth Waghodia Pipariya Gujarat India 391760

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 Sumandeep Vidyapeeth Waghodia Pipariya Gujarat India 391760

Vadodara
GUJARAT
391760
India 
Phone  9646500158  
Fax    
Email  sara.cinosh@gmail.com  
 
Source of Monetary or Material Support  
Smt. Bhikiben Kanjibhai Shah medical institue and research centre, waghodia, pipariya, vadodara, gujarat, India Pincode 391760 
 
Primary Sponsor  
Name  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre 
Address  Waghodia, 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 Harsh Rathod  Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre  Anaesthesia Department General OT complex 2nd floor Dhiraj Hospital Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre Sumandeep Vidyapeeth Waghodia Pipariya Gujarat India 391760
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 Dexmedetomidine 1mcg/kg  intravenous infusion of dexmedetomidine 1mcg/kg in 100 ml NS over 15 to 20 minutes 5 minutes before induction of general anaesthesia 
Comparator Agent  intravenous preservative free 2% lignocaine 1.5mg/kg  intravenous preservative free 2% lignocaine 1.5mg/kg 5 minutes before induction of general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients willing to give written and informed consent
male and females of age group 18 to 55 years of age
patients belonging to ASA physical status 1 and 2
patients posted for elective surgeries under general anaesthesia 
 
ExclusionCriteria 
Details  patients unwilling to participate in the study
patients with crdiovascular, cerebrovascular, hepatic and renel diseases
patients having arrhytmias or heart block
psychiatric patients
pregnancy and lactating patients
patients taking beta blockers
history of allergy to the study drugs
BM! more than 30
patients with ASA physical status of 3 and above
patients with suspected difficult airway and Mallampatti grade 3 and 4 
 
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 study hemodynamic response during laryngoscopy and endotracheal intuabtion   baseline
after administration of the test drug
after induction
at laryngoscopy and intubation
at 1 min after intubation
at 3 mins after intubation
at 5 mins after intubation 
 
Secondary Outcome  
Outcome  TimePoints 
to study sedation status using RAMSAY sedation score  post operatively for every 30 minutes till RAMSAY sedation score of 2 is achieved 
 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 STUDY TO COMPARE INTRAVENOUS DEXMEDETOMIDINE WITH INTRAVENOUS PRESERVATIVE FREE LIGNOCAINE FOR ATTENUATION OF HEMODYNAMIC RESPONSES TO LARYNGOSCOPY AND ENDOTRACHEAL INTUBATION

 

AIM: The aim of the study will be to compare intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine for attenuation of hemodynamic response during laryngoscopy and endotracheal intubation.

 

OBJECTIVE:

1.To compare heart rate using intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia.

2. To compare systolic blood pressure, diastolic blood pressure and mean arterial blood pressure using intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia.

3. To compare Spo2 using intravenous Dexmedetomidine with intravenous preservative free 2% lignocaine during laryngoscopy and endotracheal intubation in patients undergoing surgeries under general anaesthesia

 

INCLUSION CRITERIA:

Patients willing to sign written & informed consent.

Male or female patients between ages of 18 to 55 years.

Patients belonging to American Society of Anaesthesiologists (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 cardiovascular, cerebrovascular, hepatic and renaldiseases.

Patients having arrhythmias or heart block.

 Psychiatric patients.

Pregnancy & lactating women.

 Patients taking beta blockers.

History of allergy to the study drugs.

 BMI >30

 Patients with ASA physical status III and above.

Patient with suspected difficult airway and mallampatti Grade III and IV.

 

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 D and Group L of 30 patients each:

 

Group D (n=30): Patients will receive intravenous dexmedetomidine (1mcg/kg) in 100ml normal saline over 15-20 minutes 5 minutes before induction of general anaesthesia.

Group L (n=30): Patients will receive intravenous preservative free 2% lignocaine (1.5 mg/kg) 5 minutes before 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 by me at baseline, after administration of test drug, after induction, during laryngoscopy and intubation and at 1,3,5 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 and Comparative 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; chi “square test will be used. p value <0.05 will be considered statistically significant.

 

 

Likely outcome/ Benefit of the study: This prospective and comparative 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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