| CTRI Number |
CTRI/2022/04/042275 [Registered on: 28/04/2022] Trial Registered Prospectively |
| Last Modified On: |
07/04/2022 |
| 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 intravenous versus intranasal dexmedetomidine in reducing blood pressure and heart rate to laryngoscopy and endotracheal
intubation†|
|
Scientific Title of Study
|
"Comparison of intravenous versus intranasal dexmedetomidine
on attenuation of haemodynamic responses to laryngoscopy and endotracheal
intubation: A randomized double blind interventional study at SMS Medical
College, Jaipur during 2021-2023" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Trishala Jain |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached hospital,Jaipur |
| Address |
Department of Anaesthesiology,
SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Trishala Jain |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College and attached hospital,Jaipur |
| Address |
Department of Anaesthesiology,
SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414281744 |
| Fax |
|
| Email |
trishala.jain31@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumaila Naaz |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College and attached hospital,Jaipur |
| Address |
Department of Anaesthesiology,
SMS Medical College and attached Hospitals, Adarsh Nagar, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9058543688 |
| Fax |
|
| Email |
sumailanaaz8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Sawai Man Singh Medical College and Attached Hospitals,Jaipur |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology SMS Medical college and attached hospitalsJaipur |
| Address |
JLN Marg, Adarsh, Jaipur |
| 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 Sumaila Naaz |
SMS Medical College and Attached Hospitals |
JLN Marg,Adarsh Nagar ,Jaipur
Jaipur
RAJASTHAN |
9058543688
sumailanaaz8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical College and Attached Hospital,Jaipur |
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 |
Intranasal dexmedetomidine |
Intranasal dexmedetomidine (1mcg/kg) in undiluted form in both nostrils 40 min before induction |
| Intervention |
Intravenous dexmedetomidine |
Intravenous dexmedetomidine (0.50mcg/kg) through an infusion pump over 40 min before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient of ASA grade I and II.
2. Patient undergoing elective surgery (Duration 60-70 minutes) |
|
| ExclusionCriteria |
| Details |
1.History of allergy to dexmedetomidine
2.History of hypertension ,CAD,renal and hepatic dysfunctional
3. Patient with intranasal pathology like nasal polyp,ulcers and deviated septum.
4.Patient not willing to participate in the study.
5.Patient with cardiac and respiratory illness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart Rate |
Baseline,after loading dose then every 10min interval till 40 min,at the time of induction ,every 1min till 5 minutes after induction ,7 min after intubation,every 10 min after intubation thereafter upto 60 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Systolic BP,Diastolic BP and Mean Arterial Pressure |
Baseline,after loading dose then every 10min interval till 40 min,at the time of induction ,every 1min till 5 minutes after induction ,7 min after intubation,every 10 min after intubation thereafter upto 60 minutes |
| Sedation Score |
Baseline,after loading dose then every 10min interval till 40 min thereafter post operatively every 1 hour upto 4 hrs |
| Spo2 |
Baseline,after loading dose then every 10min interval till 40 min,at the time of induction ,every 1min till 5 minutes after induction ,7 min after intubation,every 10 min after intubation thereafter upto 60 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laryngoscopy and endotracheal intubation are associated with various haemodynamic changes due to sympathetic stimulation and to attenuate these response is a major challenge for anaesthesiologist. The satisfactory role of preoperative dexmedetomidine for attenuation of stress response is well established therefore in present study , we compare the efficacy of intranasal dexmedetomidine on stress response.We hypothesised that there is no significant difference between IV and IN routes of dexmedetomidine on attenuation of stress response.The study was designed to test this hypothesis. |