| CTRI Number |
CTRI/2024/07/070396 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effects of nebulized dexmedetomidine versus nebulized magnesium sulphate on reducing intubation response |
|
Scientific Title of Study
|
Comparison of hemodynamic effects of nebulized dexmedetomidine versus nebulized magnesium sulphate on attenuation of stress response during laryngoscopy and tracheal intubation- A randomized control trial |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yuvaraj karthikeyan |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesiology, Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9597113780 |
| Fax |
|
| Email |
yuvarajkarthi1997@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesiology, Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Balaji Kuppuswamy |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anesthesiology, Christian Medical College, Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
7406777127 |
| Fax |
|
| Email |
balooswamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Christain Medical College, Vellore- 632004 Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Yuvaraj karthikeyan |
| Address |
Dr Yuvaraj Karthikeyan, Department of Anesthesiology, Christian Medical College,Vellore- 632004, Tamilnadu, India |
| Type of Sponsor |
Other [self] |
|
|
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 Yuvaraj Karthikeyan |
Christian Medical College |
Department of Anesthesiology, Christian Medical College, Vellore Vellore TAMIL NADU |
9597113780
yuvarajkarthi1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board and Ethics Committee of CMC Vellore |
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 |
| Intervention |
Nebulized Dexmedetomidine |
Nebulized dexmedetomidine 1mcg per kg over 15 minutes, 10minutes prior to induction and Hemodynamic responses to laryngoscopy is observed |
| Comparator Agent |
Nebulized Magnesium sulphate |
Nebulized Magnesium sulphate 10mg per kg over 15 minutes, 10minutes prior to induction and hemodynamic responses to laryngoscopy is observed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery and belonging to ASA physical status I to II
|
|
| ExclusionCriteria |
| Details |
Patients with difficult airway, uncontrolled hypertension, heart disease with ejection fraction less than 40%, body mass index more than 35 kg/m2, history suggestive of hypersensitivity to drugs used during the study, bradycardia- heart rate less than 50 beats per minute, any heart block, hepatic impairment, renal impairment and pregnancy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic effects of preoperative nebulized dexmedetomidine and nebulized magnesium sulphate on laryngoscopy and intubation stress response attenuation |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the requirement of additional anesthetic drugs(fentanyl, propofol)in order to maintain the hemodynamics within 20% of baseline values |
1 hour |
|
|
Target Sample Size
|
Total Sample Size="164" Sample Size from India="164"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/08/2024 |
| 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="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The purpose of this study is to compare the effect of preoperative nebulised dexmedetomidine and nebulized magnesium sulphate on hemodynamic responses to laryngoscopy and endobronchial intubation . Patients coming for elective surgery meeting the required inclusion criteria will be enrolled for this study. Information about the study will be conveyed and consent obtained in the preoperative period. Patients will be divided into two groups by computer-generated block randomization: Group A will receive dexmedetomidine(1mcg/kg body weight diluted with normal saline 4ml administered over 10-15 minutes ) and Group B will receive nebulized magnesium sulphate (10mg/kg with normal saline 4ml administered over 10-15 minutes) All patients will have standard ASA monitoring with one intravenous (IV) lines. Five minutes after completion of nebulization with the study drug, all patients will be induced with IV propofol upto 2mg/kg, fentanyl 2 mcg/kg, lignocaine 1.5mg/kg and vecuronium 0.1 mg/kg, in accordance with the current standard of care given in our hospital. Anesthesia will be maintained with isoflurane to get a MAC of 1 until tracheal intubation. After 3 minutes of mask ventilation, laryngoscopy and endotracheal tube insertion. Episodes of hypotension will be treated with a bolus of Ephedrine hydrochloride 5mg or Phenylephrine 25-50 mcg . Bradycardia will be treated with 0.3-0.6 mg atropine bolus. Any hypertension or tachycardia will be treated with additional doses of propofol and/or fentanyl. Systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), and heart rate (HR), will be recorded at baseline and regular intervals. All incidences of hypertension, hypotension , tachycardia and bradycardia will be documented and the number of doses of rescue medication administered will be noted. |