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
|
|
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
|
|
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. |