| CTRI Number |
CTRI/2024/07/071334 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/07/2024 |
| 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 two drugs Lignocaine and Dexmedetomidine for fiberoptic guided awake nasal intubation in traumatic maxillofacial surgeries for the ease of intubation |
|
Scientific Title of Study
|
Effect of Lignocaine nebulisation with and without Dexmedetomidine for flexible fiberoptic guided awake nasal intubation in traumatic maxillofacial surgeries |
| 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 AYUSH SOHANI |
| Designation |
PG Resident |
| Affiliation |
PCMS RC Bhopal |
| Address |
Room no 1 Department of Anaesthesia first floor Peoples College of medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8527701126 |
| Fax |
|
| Email |
drayushsohani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahima Batra |
| Designation |
Head and Professor |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 2 Department of Anaesthesia First floor Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
975207418 |
| Fax |
|
| Email |
drmahimabatra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayush Sohani |
| Designation |
PG Resident |
| Affiliation |
Peoples College of Medical Sciences and Research Centre |
| Address |
Room no 1 Department of Anaesthesia First floor Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8527701126 |
| Fax |
|
| Email |
drayushsohani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples hospital Peoples college of Medical Sciences karond Bypass road bhanpur Bhopal 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
Peoples College of Medical Sciences Karond bypass road Bhanpur Bhopal Madhya Pradesh 462037 |
| 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 Ayush Sohani |
Peoples Hospital |
Room no 1 Department of Anaesthesia First floor Peoples Hospital Peoples College of Medical Sciences Karond Bypass Road Bhanpur Bhopal 462037
Bhopal
MADHYA PRADESH |
8527701126
drayushsohani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee PCMS and RC |
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 |
| Intervention |
Lignocaine nebulisation |
All the patient undergoing traumatic maxillofacial surgeries will be nebulized with lignocaine which is a local anaesthetic for awake nasal intubation |
| Comparator Agent |
Lignocaine with Dexmedetomidine nebulisation |
All the patient undergoing traumatic maxillofacial surgeries will be nebulized with lignocaine along with dexmedetomidine which is a alpha 2 agonist for awake nasal intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
All patients scheduled for elective maxillofacial surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA grade 3 and 4
Pregnancy and lactating mother
Hemodynamic instability
Allergy to study drugs
Patient with nasal polyps and mass |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ease of intubation |
40 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset of action
hemodynamic parameters
patient comfort
cough response |
40 minutes |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
05/08/2024 |
| 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 - NO
|
|
Brief Summary
|
This is a resident based post graduation thesis. The topic is Effect of Lignocaine nebulisation with and without Dexmedetomidine for flexible fiberoptic guided awake nasal intubation in traumatic maxillofacial surgeries for which patient will be taken according to inclusion criteria and their haemodynamic variations will be recorded as per proforma after taking their informed consent and results will be concluded after 19 months of study period. |