| CTRI Number |
CTRI/2023/12/060483 [Registered on: 04/12/2023] Trial Registered Prospectively |
| Last Modified On: |
12/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of dexmedetomidine mist inhalation to magnesium sulfate in terms of how blood pressure and hear rate responds when a doctor inserts a tube into windpipe and how often the patient gets sore throat after surgery |
|
Scientific Title of Study
|
EFFECT OF NEBULIZATION WITH DEXMEDETOMIDINE VERSUS MAGNESIUM SULPHATE ON HEMODYNAMIC RESPONSE DURING LARYNGOSCOPY AND INTUBATION AND INCIDENCE OF POST OPERATIVE SORE THROAT |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Fateh Pal Singh Gill |
| Designation |
Resident Anaesthesiology |
| Affiliation |
Dr. D Y Patil Medical College and Research Centre |
| Address |
Dr. D Y Patil Medical College, Hospital and Research Centre.
Department of Anaesthesiology
Pune
MAHARASHTRA
411018
India |
| Phone |
02067116499 |
| Fax |
|
| Email |
gillfateh13@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C M Suryawanshi |
| Designation |
Professor and HOD Department of Anaesthesiology |
| Affiliation |
Dr. D Y Patil Medical College and Research Centre, Department of Anaesthesiology |
| Address |
Dr. D Y Patil Medical College, Hospital and Research Centre.
Department of Anaesthesiology
Pune
MAHARASHTRA
411018
India |
| Phone |
02067116499 |
| Fax |
|
| Email |
Chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr C M Suryawanshi |
| Designation |
Professor and HOD Department of Anaesthesiology |
| Affiliation |
Dr. D Y Patil Medical College and Research Centre, Department of Anaesthesiology |
| Address |
Dr. D Y Patil Medical College, Hospital and Research Centre.
Department of Anaesthesiology.
Pune
MAHARASHTRA
411018
India |
| Phone |
02067116499 |
| Fax |
|
| Email |
Chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy; high tech ot; 5th floor |
|
|
Primary Sponsor
|
| Name |
Dr Fateh Pal Singh Gill |
| Address |
Dr. D Y Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune |
| Type of Sponsor |
Private 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 Fateh Pal Singh Gill |
Hightech OT complex, 5th floor, hightech building |
Department of Anaesthesia, Dr D Y Patil Medical College, Hospital and Research Center, Pimpri, Pune
Pune
MAHARASHTRA |
9996646526
gillfateh13@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS SUB-COMMITTEE Dr. D.Y. Patil Medical College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ASA 1 and ASA 2 patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Laryngoscopy and inubation |
Laryngoscopy and intubation with endotracheal tube will be done for patients posted for surgery under general anaesthesia |
| Comparator Agent |
Nebulization with dexmedetomedine |
Preoperative nebulization with dexmedetomedine and its effect on hemodynamic response during laryngoscopy and intubation and incidence of post operative sore throat |
| Comparator Agent |
Nebulization with magnesium sulphate |
Preoperative nebulization with magnesium sulphate and its effect on hemodynamic response during laryngoscopy and intubation and incidence of post operative sore throat |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA grade I or II fit patients.
2. Patients aged between 18 and 60 years of age.
3. Patients undergoing surgeries under general anaesthesia.
4. Haemodynamically stable patients with all routine investigations within normal limits and without any comorbidities.
5.Written informed consent from the concerned patient.
|
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to participate in the study.
2.Patients with ASA grade III and above physical status.
3.Patients who are aged less than 18 and more than 60 years of age.
4. Patients who are posted for emergency procedures.
5. Patients with known allergy to the study drugs.
6. Patients with difficult intubation.
7. Patients who are obese.
8. Patients who have psychiatric, neurological, neuromuscular or cardiovascular disease or impairment of hepatic or renal function. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the attenuation of pressor responses to laryngoscopy and endotracheal intubation with preoperative nebulization with dexmedetomidine and incidence of post operative sore throat |
Pre intubation, scopy 0 minutes, every 1 minute upto 10 minutes post intubation, after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the attenuation of pressor responses to laryngoscopy and endotracheal intubation with preoperative nebulization with dexmedetomidine and incidence of post operative sore throat |
Pre intubation, scopy 0 minutes, every 1 minute upto 10 minutes post intubation, after extubation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 1 |
|
Date of First Enrollment (India)
|
15/12/2023 |
| 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="3"
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
|
It is a randomized, prospective, comparative, double blinded study where in pre operative nebulization with dexmedetomedine and magnesium sulphate are compared for the attenuation of hemodynamic response during laryngoscopy and edotracheal intubation before a surgical procedure under general anaesthesia. |