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CTRI Number  CTRI/2019/08/020584 [Registered on: 06/08/2019] Trial Registered Prospectively
Last Modified On: 05/05/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   To see the effectiveness of a drug (dexmedetomidine) given by two methods (in vein or nose) in decreasing the rise of pulse rate and blood pressure while giving anaesthesia. 
Scientific Title of Study   A comparative study of intravenous versus intranasal dexmedetomidine for attenuation of haemodynamic response to laryngoscopy and intubation in adults undergoing elective surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anjali Kochhar 
Designation  Assistant Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of anaesthesia and intensive care, VMMC and Safdarjung Hospital, New Delhi

South
DELHI
110029
India 
Phone  9999197721  
Fax    
Email  kochharanjali0@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjali Kochhar 
Designation  Assistant Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of anaesthesia and intensive care, VMMC and Safdarjung Hospital, New Delhi
262,Narmada Apartments,New Delhi

DELHI
110029
India 
Phone  9999197721  
Fax    
Email  kochharanjali0@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anjali Kochhar 
Designation  Assistant Professor 
Affiliation  VMMC and Safdarjung Hospital 
Address  Department of anaesthesia and intensive care, VMMC and Safdarjung Hospital, New Delhi
262,Narmada Apartments,New Delhi

DELHI
110029
India 
Phone  9999197721  
Fax    
Email  kochharanjali0@gmail.com  
 
Source of Monetary or Material Support  
VMMC and Safdarjung Hospital, New Delhi 
 
Primary Sponsor  
Name  VMMC and Safdarjung Hospital 
Address  VMMC and Safdarjung Hospital, New Delhi 
Type of Sponsor  Government 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 Anjali Kochhar  Surgery OT ,Department of Anaesthesia ,Main OT Complex   Safdarjung Hospital ANSARI Nagar New Delhi-29
South
DELHI 
9999197721

kochharanjali0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, VMMC and Safdarjung Hospital,NEW DELHI  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intranasal Dexmedetomidine   Dexmedetomidine (1µgkg-1), nasal instillation, 30 minutes before induction of anaesthesia. 
Comparator Agent  Intravenous Dexmedetomidine  Dexmedetomidine (0.5 µgkg-1), given intravenously over 10 minutes, before induction of anaesthesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Adult patients (18-65 years), of either sex, having ASA physical status I
2.Undergoing elective surgery under general anaesthesia with tracheal intubation.

 
 
ExclusionCriteria 
Details  1.Patients having any nasal pathology
2.Predicted difficult laryngoscopy/ intubation
3.Pregnancy
4.Known allergy to study medication 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of intravenous with intranasal dexmedetomidine for attenuation of haemodynamic response to laryngoscopy and tracheal intubation with regard to heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure at various time points  Haemodynamic parameters heart rate, systolic blood pressure, diastolic blood pressure and mean arterial pressure), oxygen saturation (SpO2) and end tidal carbon dioxide (EtCO2) will be recorded at 1.baseline
2.after nasal pre-medication (at 10 and 20 min),
3. 5 and 10 min of intravenous infusion of study drug/pre-induction,
4.post-induction,
5. 3 min post induction
6. post-intubation (at 1,3,5 and 10 min) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pre-induction sedation score

2. Induction dose of propofol  
1.Sedation score (Ramsay sedation score) will be recorded at
a)baseline in the pre-operative area
b)before induction of anaesthesia
c) at recovery.
2.Induction dose of propofol required until loss of verbal contact will be noted at the time of injecting propofol 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   15/09/2019 
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="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study will help us to find out effective of intravenoyus versus nasal dexmedetomidine in blunting of hameodynamic response to intubation. It is important to blunt haemodynamic response to intubation as it can have deleterious effects in patents with cardiac disease or hypertension.
 
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