| CTRI Number |
CTRI/2024/09/073422 [Registered on: 05/09/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Two Drugs for Reducing Heart Rate and Blood Pressure During Intubation in General Anesthesia |
|
Scientific Title of Study
|
A comparative study between nebulized magnesium sulphate and dexmedetomidine for attenuation of hemodynamic response to larngoscopy and endotracheal intubation a double blinded randomized control study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
P Abenaya |
| Designation |
1st yr PG |
| Affiliation |
Sri Venkateshwaraa medical college hospital and research center |
| Address |
Department of Anesthesiology
SVMCH RC
2nd floor OT complex
NO 13-A Pondy Villupuram Main road Ariyur Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7867987511 |
| Fax |
|
| Email |
abenayaabe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.R.Jayashridevi |
| Designation |
Professor |
| Affiliation |
Sri Venkateshwaraa medical college hospital and research center |
| Address |
Department of Anesthesiology
SVMCH RC
2nd floor OT complex
NO 13-A Pondy Villupuram Main road Ariyur Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P Abenaya |
| Designation |
1st yr PG |
| Affiliation |
Sri Venkateshwaraa medical college hospital and research center |
| Address |
Department of Anesthesiology
SVMCH RC
2nd floor OT complex
NO 13-A Pondy Villupuram Main road Ariyur Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
7867987511 |
| Fax |
|
| Email |
abenayaabe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwaraa medical college hospital and research cener,No 13 A, Pondy villupuram main road,Ariyur, Puducherry,India,605102 |
|
|
Primary Sponsor
|
| Name |
P Abenaya |
| Address |
Department of Anaesthesiology
SVMCH RC
2nd floor OT complex
13-A Pondy Villupuram main road, Ariyur, Puducherry 605107 |
| 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 P Abenaya |
Sri Venkateshwara Medical College hospital and research center |
Department of Anaesthesiology, OT complex, 2nd floor,no 1, Pondy Villupuram main road, Ariyur
Pondicherry
PONDICHERRY |
7867987511
abenayaabe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committe (Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
comparative study between nebulized magnesium sulphate and dexmedetomidine for attenuation of hemodynamic response to laryngoscopy and intubation |
Group A:nebulized Dexmedetomidine 1mcg/kg response noted for decrease in hemodynamic response to laryngoscopy and intubation,
total duration of the study is approx 30 minutes |
| Comparator Agent |
comparative study between nebulized magnesium sulphate and dexmedetomidine for attenuation of hemodynamic response to laryngoscopy and intubation |
Group B:nebulized Magnesium sulphate 1mg/kg response noted for decrease in hemodynamic response to laryngoscopy and intubation,
total duration of the study is approx 30 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Between 18 and 60 years
ASA grade 1 and 2
Modified mallampatti grading 1 and 2 |
|
| ExclusionCriteria |
| Details |
known case of drug allergies
uncontrolled hypertension
pregnant patients |
|
|
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 alteration in heart rate from baseline pre nebulization to 1 minute after intubation in response to laryngoscopy and endotracheal intubation |
0 min, 1 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the alteration in heart rate at other time points and observe alteration in systolic blood pressure, diastolic blood pressure, mean arterial pressure at |
HR-2 min after intubation,5min after intubation, 10 min after intubation
BP- 0 min pre nebulization
1,2,5,10 minute post intubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
25/09/2024 |
| 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="1"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [abenayaabe@gmail.com].
- For how long will this data be available start date provided 10-09-2024 and end date provided 10-03-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
During laryngoscopy and endotracheal inubation, patients may have increase in heart rate and blood pressure. To attenuate this response we are using 2 drugs namely Dexmedetomidine and Magnesium sulphate in a nebulized form. This study aims to compare between Dexmedetomidine and Magnesium sulphate. Magnesium sulphate inhibits catecholamine release from adrenal glands, reduces serum epinephrine and cause decrease in atrial contraction, bradycardia and vasodilation Dexmedetomidine has sympatholytic,sedative, amnestic, analgesic effects |