| CTRI Number |
CTRI/2024/12/078752 [Registered on: 30/12/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Which drug amongst dexmedetomidine and lignocaine produces better surface anaesthesia for facilitating fiberoptic intubation |
|
Scientific Title of Study
|
A comparative study to evaluate the effectiveness of nebulised dexmedetomidine versus nebulised lignocaine the haemodynamic response to awake fiberoptic intubation in patients of head & neck cancers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Asim Rasheed |
| Designation |
Additional Professor |
| Affiliation |
Kalyan Singh Superspeciality Cancer Institute |
| Address |
Department Of Anaesthesiology
Kalyan Singh Superspeciality Cancer Institute Chak Gajaria Lucknow
Lucknow
UTTAR PRADESH
226020
India |
| Phone |
9760071947 |
| Fax |
|
| Email |
drmohdasim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mohd Asim Rasheed |
| Designation |
Additional Professor |
| Affiliation |
Kalyan Singh Superspeciality Cancer Institute |
| Address |
Department Of Anaesthesiology
Kalyan Singh Superspeciality Cancer Institute Chak Gajaria Lucknow
Lucknow
UTTAR PRADESH
226020
India |
| Phone |
9760071947 |
| Fax |
|
| Email |
drmohdasim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohd Asim Rasheed |
| Designation |
Additional Professor |
| Affiliation |
Kalyan Singh Superspeciality Cancer Institute |
| Address |
Department Of Anaesthesiology
Kalyan Singh Superspeciality Cancer Institute Chak Gajaria Lucknow
Lucknow
UTTAR PRADESH
226020
India |
| Phone |
9760071947 |
| Fax |
|
| Email |
drmohdasim@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kalyan Singh Superspeciality Cancer Institute, Chak Gajaria, Lucknow 226020 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Kalyan Singh Superspeciality Cancer Institute |
| Address |
Kalyan Singh Superspeciality Cancer Institute, Chak Gajaria, Lucknow 226020 Uttar Pradesh India |
| Type of Sponsor |
Research institution |
|
|
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 Mohd Asim Rasheed |
Kalyan Singh Superspeciality Cancer Institute |
Room No. 242
Department Of Anaesthesiology
Lucknow
UTTAR PRADESH |
09760071947
drmohdasim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics CommitteeKalyan Singh Superspeciality Cancer Institute, Chak Gajaria, Lucknow 226020 Uttar Pradesh India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, (2) ICD-10 Condition: C01||Malignant neoplasm of base of tongue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nebulised lignocaine |
nebulised lignocaine given in the pre operative area for anaesthetising the airway.
A total of 60 patients will be enrolled in the prospective, randomised double blinded study. Group D will be nebulised with dexmedetomidine in a dose of 1µgm/kg in 4 ml of normal saline and group L will be nebulised with 4 ml of 2% lignocaine. The nebulisation will be done until the whole drug is administered through nebulisation. |
| Comparator Agent |
Intervention |
A total of 60 patients will be enrolled in the prospective, randomised double blinded study.
Group D will be nebulised with dexmedetomidine in a dose of 1µgm/kg in 4 ml of normal saline and group L will be nebulised with 4 ml of 2% lignocaine.
The nebulisation will be done until the whole drug is administered through nebulisation.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Additional Inclusion Criteria
1. ASA grade 1 and II
2. BMI more than 18kg/m2 and below 29kg/m2
3. Elective surgeries under general anaesthesia
4. Who had given valid informed consent
5. All MP grades including patients with zero mouth opening.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. BMI not between 18kg/m2 29kg/m2
3. Patient allergic to lignocaine or its preservative
4. Emergency surgery and history of laryngeal and pharyngeal surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Systolic blood pressure Diastolic blood pressure
Heart rate
Mean Arterial Pressure |
Pre operative period (Before start of nebulisation)
during procedure (Fiberoptic intubation)
then after 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19 and 20 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects associated with the use of these drugs |
Pre operative period (Before start of nebulisation)
during procedure (Fiberoptic intubation)
then after 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19 & 20 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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/02/2025 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 study aims to
compare the effectiveness of nebulised Lignocaine (4 ml of 2% lignocaine) and
dexmedetomidine (1µm/kg in 4 ml of normal saline) to blunt the haemodynamic
response (as a marker of surface anaesthesia) in patients of head & neck cancers
undergoing general anaesthesia. |