| CTRI Number |
CTRI/2020/09/027752 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
20/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessing the effects of intravenous dexmedetomidine on heart rate, blood pressure and bispectral index during endotracheal intubation under general anaesthesia |
|
Scientific Title of Study
|
Effects of intravenous dexmedetomidine on intubation response and bispectral index under general anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sachin S |
| Designation |
Junior Resident |
| Affiliation |
Nitte University |
| Address |
Dept. of Anaesthesiology and Critical Care,First Floor, K S Hegde Medical Academy,P.O. Nityanandanagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9483625398 |
| Fax |
|
| Email |
sachinshanmukhappa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gayathri Bhat |
| Designation |
Professor |
| Affiliation |
Nitte University |
| Address |
Dept. Of Anaesthesiology and Critical Care, First Floor, K S Hegde Medical Academy, P.O. Nityanandanagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448467181 |
| Fax |
|
| Email |
gaibhat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gayathri Bhat |
| Designation |
Professor |
| Affiliation |
Nitte University |
| Address |
Dept. Of Anaesthesiology and Critical Care, First Floor, K S Hegde Medical Academy, P.O. Nityanandanagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448467181 |
| Fax |
|
| Email |
gaibhat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. Of Anaesthesiology and Critical Care, First Floor, K S Hegde Medical Academy, P.O. Nityanandanagar, Deralakatte, Mangaluru |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Dept. Of Anaesthesiology & Critical care, P.O. Nityanandanagar, Deralakatte, Mangaluru-575018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sachin S |
K S Hegde Medical Academy |
Dept. Of Anaesthesiology and Critical Care, First Floor, K S Hegde Medical Academy, P.O. Nityanandanagar, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
9483625398
sachinshanmukhappa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KSHEMA Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H60-H95||Diseases of the ear and mastoid process, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine 1mcg/kg loading dose 10-15 minutes before induction of anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA PS I and II |
|
| ExclusionCriteria |
| Details |
Anticipated difficult airway
Patients on beta blockers
Pregnant and lactating patients
Patients refusal
Allergic to drugs used in the study
Baseline heart rate less than 50 bpm |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effects of dexmedetomidine on heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure and bispectral index during intubation response
|
From baseline to ten minutes post intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess any adverse reactions such as sedation, arrthymias etc
|
Baseline
Before induction
Before laryngoscopy
Soon after laryngoscopy and intubation
Every minute after intubation till the next 10 minutes
|
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
11/09/2020 |
| 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) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
BACKGROUND
Laryngoscopy and intubation being noxious stimuli,
elicits remarkable sympathetic activity. It causes abrupt rise in the blood pressure
and heart rate which returns to baseline values after cessation of the stimulus.
Aim:
To assess the effectiveness of dexmedetomidine in attenuating intubation response with bispectral index
(BIS) monitoring
Objectives:
Primary objective is to observe the BIS index along
with haemodynamic changes during laryngoscopy and intubation. The adverse
effects like sedation and arrhythmias are noted as secondary objectives.
Method:
After approval of Institutional Ethics Committee, 40 patients
belonging to American
Society of Anaesthesiologists (ASA) class I, II, aged 18 to 60 years will be included with informed consent.
Patients will be divided into group D (Dexmedetomidine) and group C(Control), and IV
infusion of dexmedetomidine 1mcg/kg in 100ml of normal saline and plain 100 ml
normal saline will be given to respective groups over 15-20 min before induction. Haemodynamic
parameters like HR, SBP, DBP, MAP and BIS
index will be monitored
and documented at baseline, before induction, before laryngoscopy, post
intubation, every minute after intubation till the next 10 minutes. Mann Whitney U test will be used for
Statistical analysis of the mean changes of the above parameters. Chi
Square test will be used for analysis of age, sex, weight, duration of laryngoscopy
in both the groups.
|