| CTRI Number |
CTRI/2023/12/060709 [Registered on: 22/12/2023] Trial Registered Prospectively |
| Last Modified On: |
20/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A scientific experiment to study the attenuation of intubation response with dexmeditomedine nebulization & sublingual nitroglycerin spray |
|
Scientific Title of Study
|
Attenuation of hemodynamic response to laryngoscope & endotracheal intubation with preinduction dexmeditomedine nebulization versus sublingual nitroglycerin spray in patients undergoing elective surgeries - a prospective randomised comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hemalatha S |
| Designation |
Post graduate |
| Affiliation |
Mysore medical college and research institute |
| Address |
2 nd floor department of anaesthesiology new stone building KR Hospital Mysore medical College and research institute Mysore
2 nd floor department of anaesthesiology new stone building KR Hospital Mysore medical College and research institute Mysore
Bangalore
KARNATAKA
570001
India |
| Phone |
9535991848 |
| Fax |
|
| Email |
nesarahema2396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B C Vijayalakshmi |
| Designation |
Professor |
| Affiliation |
Mysore Medical College and Research Institute |
| Address |
Mysore Medical College and Research Institute, Irwin road, Mysuru
Mysore Medical College and Research Institute, Irwin road, Mysuru
Mysore
KARNATAKA
570001
India |
| Phone |
9886239622 |
| Fax |
|
| Email |
vijayanagaraj@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemalatha S |
| Designation |
Post graduate |
| Affiliation |
Mysore medical college and research institute |
| Address |
2 nd floor department of anaesthesiology new stone building KR Hospital Mysore medical College and research institute Mysore
2 nd floor department of anaesthesiology new stone building KR Hospital Mysore medical College and research institute Mysore
Bangalore
KARNATAKA
570001
India |
| Phone |
9535991848 |
| Fax |
|
| Email |
nesarahema2396@gmail.com |
|
|
Source of Monetary or Material Support
|
| KR Hospital, Irwin Road, Devarajan Mohalla, Yadavagiri, Mysore, Karnataka 570001 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology |
| Address |
2 nd floor department of anaesthesiology new stone building KR Hospital Mysore medical College and research institute Mysore 570001 |
| 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 |
| Hemalatha S |
KR Hospital , Mysore |
KR Hospital attached to MMCRI , Irwin Road, Devaraja mohalla, Mysore-570001
Mysore
KARNATAKA |
9535991848
nesarahema2396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Mysore medical College and research institute and associated hospitals Mysore 570021 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group D |
Nebulization with dexmeditomedine 1 µg/kg diluted to 5ml of normal saline 30 minutes before induction of anaesthesia |
| Comparator Agent |
Group N |
Sublingual nitroglycerin spray 2puffs (800 µg) 2 minutes before induction of anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 - 60 years
Both genders
ASA grade I and II |
|
| ExclusionCriteria |
| Details |
Patient refusal
Pregnancy
Emergency surgery
Patient with anticipated difficult airway
Modified mallampatti III and IV
Laryngoscope and intubation time >20s
Obese patients with BMI >30kg/m2
H/o chronic hepatic renal or cardiac disease
H/o drug allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Attenuation of intubation response with dexmeditomedine nebulization versus sublingual nitroglycerin spray |
Baseline
At induction
1 min after induction
2 min after induction
3 min after induction
At intubation
1 min after intubation
2 min after intubation
3 min after intubation
5 min after intubation
10 min after intubation
15 min after intubation
30 min after intubation
At extubation
5 min after extubation
10 min after extubation
15 min after extubation
20 min after extubation
25 min after extubation
30 min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects of dexmeditomedine and nitroglycerin |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/12/2023 |
| 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="6"
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
|
This study is a prospective randomised comparative study for attenuation of hemodynamic response to laryngoscopy and endotracheal intubation with preinduction dexmeditomedine nebulization versus sublingual nitroglycerin spray in patients undergoing elective surgeries |