| CTRI Number |
CTRI/2025/01/079170 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare preoperative nebulisation with Fentanyl or Dexmedetomidine or Magnesium Sulphate in blunting hemodynamic response to Laryngoscopy and Tracheal intubation in 171 participants chosen randomly. |
|
Scientific Title of Study
|
A randomised comparative study of pre-op nebulization with Fentanyl, Dexmedetomidine or Magnesium Sulphate for blunting haemodynamic response to Laryngoscopy and Tracheal intubation |
| 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 Subashini KJ |
| Designation |
Junior Resident -2 |
| Affiliation |
Grant Goverment Medical College and Sir JJ Hospital. |
| Address |
Department of Anaesthesiology,6th floor, Main building, Grant Government Medical College and Sir JJ Hospital, Byculla.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
|
| Fax |
|
| Email |
subared983@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukriti Atram |
| Designation |
Associate Professor |
| Affiliation |
Grant Government Medical college and Sir JJ Hospital. |
| Address |
Department of Anesthesiology, 6th floor, Main Building, Grant Government Medical College AND Sir JJ Hospital, Byculla.
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sukriti Atram |
| Designation |
Associate Professor |
| Affiliation |
Grant Government Medical College and Sir JJ Hospital. |
| Address |
Department of Anesthesiology, 6th floor, Main Building, Grant Government Medical College And Sir JJ Hospital, Byculla.
MAHARASHTRA
400008
India |
| Phone |
9004083034 |
| Fax |
|
| Email |
sukritiatram@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department OF Anesthesiology, Grant Government Medical College And Sir JJ Hospital, Byculla, Mumbai 400008 |
|
|
Primary Sponsor
|
| Name |
Dr Subashini KJ |
| Address |
Department of Anesthesiology, Grant Government Medical college and Sir JJ Hospital, Byculla, Mumbai-400008 |
| 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 SUBASHINI KJ |
Grant Government Medical College and Sir JJ Hospital. |
Department of Anesthesiology, 6th Floor, Main Building.
Mumbai
MAHARASHTRA |
9952154491
subared983@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF ETHICS COMMITEE,GRANT GOVERNMENT MEDICAL COLLEGE,MUMBAI,400008 |
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 |
| Comparator Agent |
Pre-operative nebulization with Dexmedetomidine. |
Nebulization with Injection Dexmedetomidine 1 mcg/kg of body weight diluted in 5ml 0.9% Normal Saline as Group-B for 15 to 20 minutes with oxygen flow of 6 liters per minute and vitals during pre-nebulization (T01), post nebulization (T02), pre-intubation (T03), during laryngoscopy (TL), during intubation (TI), and after 1 min (T1), 2 min (T2), 3 min (T3), 5 min (T4), 10 min (T5), 15 min (T6), 20 min (T7), 25 min (T8), 30 min (T9), 1st hr(T10), 2nd hr (T11) of intubation will be recorded. |
| Comparator Agent |
Pre-operative nebulization with Fentanyl. |
Nebulization with injection Fentanyl 1 mcg/kg of body weight diluted in 5ml 0.9% Normal Saline as Group-A for 15 to 20 minutes with oxygen flow of 6 liters per minute and vitals during pre-nebulization (T01), post nebulization (T02), pre-intubation (T03), during laryngoscopy (TL), during intubation (TI), and after 1 min (T1), 2 min (T2), 3 min (T3), 5 min (T4), 10 min (T5), 15 min (T6), 20 min (T7), 25 min (T8), 30 min (T9), 1st hr(T10), 2nd hr (T11) of intubation will be recorded. |
| Comparator Agent |
Pre-operative nebulization with Magnesium Sulphate. |
Nebulization with Injection Magnesium Sulphate 40 mg/kg of body weight diluted in 5ml 0.9% Normal Saline as Group-C for 15 to 20 minutes with oxygen flow of 6 liters per minute and vitals during pre-nebulization (T01), post nebulization (T02), pre-intubation (T03), during laryngoscopy (TL), during intubation (TI), and after 1 min (T1), 2 min (T2), 3 min (T3), 5 min (T4), 10 min (T5), 15 min (T6), 20 min (T7), 25 min (T8), 30 min (T9), 1st hr(T10), 2nd hr (T11) of intubation will be recorded. |
| Intervention |
Pre-operative nebulization. |
Nebulization with three comparator agents namely Fentanyl(1 mcg/kg), Dexmedetomidine(1 mcg/kg) and Magnesium Sulphate (40 mg/kg) randomized as Group-A, Group-B and Group-C respectively, for 15 to 20 minutes in sitting position with oxygen flow of 6 liters per minute and vitals during pre-nebulization (T01), post nebulization (T02), pre-intubation (T03), during laryngoscopy (TL), during intubation (TI), and after 1 min (T1), 2 min (T2), 3 min (T3), 5 min (T4), 10 min (T5), 15 min (T6), 20 min (T7), 25 min (T8), 30 min (T9), 1st hr(T10), 2nd hr (T11) of intubation will be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to participate in the study and giving valid consent
2. Patients with asa grade 1 and 2 in routine cases
3. Patients with mpc grade 1 and 2
4. Elective surgeries |
|
| ExclusionCriteria |
| Details |
1.Patients who have uncontrolled diabetis mellitus
or uncontrolled hypertension
2.Patients with coagulopathies or on
anticoagulation medications
3.Patients who is having known hypersensitivity to
study drugs
4.Patients with mpc 3 and 4, video laryngoscope
guided or awake fiberoptic guided intubation
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of nebulized drugs. |
Baseline, after 1 min , 2 min , 3 min , 5 min , 10 min , 15 min , 20 min, 25 min, 30 min, 1 hour, 2 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the onset of
attenuation response caused
by laryngoscopy &
intubation.
2. To assess the duration of
attenuation response caused
by laryngoscopy &
intubation.
3. To observe & report any
adverse reactions. |
Baseline, after 1 min , 2 min , 3 min , 5 min , 10 min , 15 min , 20 min, 25 min, 30 min, 1 hour, 2 hours. |
|
|
Target Sample Size
|
Total Sample Size="171"
Sample Size from India="171"
Final Enrollment numbers achieved (Total)= "171"
Final Enrollment numbers achieved (India)="171" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
14/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="7" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
THIS STUDY IS RANDOMIZED COMPARATIVE STUDY OF PRE-OP NEBULIZATION WITH FENTANYL, DEXMEDETOMIDINE OR MAGNESIUM SULPHATE FOR BLUNTING HAEMODYNAMIC RESPONSE AND TRACHEAL INTUBATION. THE PRIMARY OBJECTIVE IS TO COMPARE THE EFFICACY OF NEBULIZED DRUGS AND SECONDARY OBJECTIVE IS TO ASSESS THE ONSET AND DURATION OF ATTENUATION RESPONSE AND TO REPORT ANY ADVERSE REACTIONS. |