| CTRI Number |
CTRI/2021/09/036806 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
16/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare nebulized
fentanyl, dexmedetomedine and magnesium sulphate for attenuation of stress response to
laryngoscopy and intubation |
|
Scientific Title of Study
|
A prospective, double blinded randomized study to evaluate and compare nebulized
fentanyl, dexmedetomedine and magnesium sulphate for attenuation of haemodynamic stress response to
laryngoscopy and intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
niharika grover |
| Designation |
assistant proffesor |
| Affiliation |
esic medical college and hospital, faridabad |
| Address |
anaesthesia depaartment
operation theatre complex
3rd floor, opd building
esic medical college and hospital, nh 3 , n.i.t. faridabad, haryana
Faridabad
HARYANA
121001
India |
| Phone |
9811632907 |
| Fax |
|
| Email |
drniharikagroverss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
niharika grover |
| Designation |
assistant proffesor |
| Affiliation |
esic medical college and hospital, faridabad |
| Address |
anaesthesia department
ot complex, 3rd floor, opd building , esic medical college and hospital, nh 3 , n.i.t. faridabad, haryana
Faridabad
HARYANA
121001
India |
| Phone |
9811632907 |
| Fax |
|
| Email |
drniharikagroverss@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
niharika grover |
| Designation |
assistant proffesor |
| Affiliation |
esic medical college and hospital, faridabad |
| Address |
anaesthesia depsrtment
ot complex, 3rd floor, opd building,esic medical college and hospital, nh 3 , n.i.t. faridabad, haryana
Faridabad
HARYANA
121001
India |
| Phone |
9811632907 |
| Fax |
|
| Email |
drniharikagroverss@gmail.com |
|
|
Source of Monetary or Material Support
|
| esic medical college, faridabad |
|
|
Primary Sponsor
|
| Name |
esic medical college and hospitalfaridabad |
| Address |
esic medical college and hospital, nh3 ,n.i.t. faridabad, haryana |
| 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 |
| dr niharika grover |
esic faridabad |
anaesthesia department
ot complex, 3rd floor, opd building
esic medical college and hospital. faridabad
nh3 n.i.t. faridabad ,haryana 121001
Faridabad
HARYANA |
9811632907
drniharikagrover@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomedine Nebulised in dose of 1ug/kg in ms with oxygen @ 6l/m |
Nebulised form for attenuation of haemodynamic response to intubation |
| Comparator Agent |
fentanyl Nebulised 1 ug/kg in ms with oxygen @6l/m |
nebulized form for attenuation of haemodynamic response to intubation |
| Intervention |
magnesium sulphate Nebulised 40 mg/kg maximum of 2 g in normal saline with oxygen @ 6 l/m |
nebulized form for attenuation of haemodynamic response to laryngoscopy and intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age of 18 and 60 yrs
ASA grade 1 and 2
Patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation
Mallampati grading I to II
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Drug allergy
Patient with apparent difficult airway
Patients in ASA grade III & above
Patients who require Intubation time > 20 sec
Patients having BMI>30
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate attenuation of haemodynamic response to laryngoscopy and intubation
|
baseline reading, after nebulisation, 2min, 5min, 10 min after intubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| adverse effect in any |
2 min 5 min 10 min after intubation |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2021 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
applied for pusblishing in ija
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
direct laryngoscopy and intubation result in pressor response which is associated with increase in heart rate and blood pressure due to stimulation of sympathetic system. it can cause serious complications in patients of coronary artery disease, raised icp etcmany studies compare intravenous form we will compare nebulised dexmedetomedine, magnesium sulphate and fentanyl for attenuation of haemodynamic response to laryngoscopy and intubation primary objective to evaluate pressoer response. secondary outcome to record any side effects this prospective .double blinded randomised study will be conducted in esic faridabad with above stated inclusion and exclusion criteria statistical test anova with post hoc bonferroni correction for quantitative and chi square for qualitative data preanaesthetic evaluation will be done. pt kept fasting by asa guidelines informed written consent to be taken. randomisation with envelope method into 3 groups preop vitals - heart rate. systolic bp , diastolic bp ,mean arterial pressure recorded
group a : nebilsation with fentanyl 1mcg/kg in normal saline total 5 ml @ o2 6l/m before induction group b:nebulisation with dexmedetomedine 1mcg/kg group c: nebulisation with magnesium sulphate 40mg/kg max up to 2g
after neb pt taken in ot and hr.sbp.dbp.map recorded preoxygenation done. premedication with inj fentanyl 2mcg/kg iv, induction with propofol 2mg/kg iv check ventilation vec 0.08mg/kg iv 3min ippv followed by dl scopy and intubation 2 min . 5 min and 10 min after intubation hr. sbp.dbp.map will be recordedno stimulus allowed during study period fall in map>20% treated with inj ephedfrine 6mg iv and hr <45/min treated by atropin 0.6 mg iv no ethical implications as these drugs are routinely used in anaesthesia practice |