| CTRI Number |
CTRI/2020/11/029241 [Registered on: 19/11/2020] Trial Registered Prospectively |
| Last Modified On: |
18/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between nebulisation with dexmedetomidine and nebulisation with Ketamine as an accessory to nebulisation with lignocaine for awake fiberoptic intubation. |
|
Scientific Title of Study
|
Comparative evaluation of Dexmedetomidine nebulisation and Ketamine nebulisation as an adjuvant to Lignocaine for awake fiberoptic intubation. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawana Sharma |
| Designation |
Junior Resident |
| Affiliation |
king george medical university |
| Address |
Department of Anaesthesiology,
KGMU,
Lucknow,
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
7407533830 |
| Fax |
|
| Email |
bhawray13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monica Kohli |
| Designation |
Professor |
| Affiliation |
king george medical university |
| Address |
Department of Anaesthesiology,
KGMU,
Lucknow,
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839041228 |
| Fax |
|
| Email |
monica_kohli@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica Kohli |
| Designation |
Professor |
| Affiliation |
king george medical university |
| Address |
Department of Anaesthesiology,
KGMU,
Lucknow,
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9839041228 |
| Fax |
|
| Email |
monica_kohli@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| king George medical university, Lucknow. |
|
|
Primary Sponsor
|
| Name |
King Georges Medical University |
| Address |
Department of anaesthesiology,
KGMU,,
Lucknow,
uttarpradesh
226003 |
| 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 |
| bhawana sharma |
King George Medical University |
dept of anaesthesiology,
Ground floor,
KGMU,
Lucknow
UTTAR PRADESH |
7407533830
bhawray13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, KGMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nebulisation |
patients will be nebulised with ketamine (3mg/kg) and dexmedetomedine (1mcg/kg) as an adjuvant to 6ml of lignocaine 4% before the initiation of awake fiberoptic intubation and the ease of awake fiberoptic intubation will be assessed thereafter. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with American Society of Anaesthesiology grading of 1 and 2.
Patients having Mallampati grading of 3 and 4 and mouth opening less than 2 finger and also patients in whom neck extension is contraindicated.
|
|
| ExclusionCriteria |
| Details |
patients with any type of AV block, bradycardia, hypotension, ventricular dysfunction, heart failure, coronary disease.
patients with nasal pathology and recent epistaxis.
allergy to drugs being used in the study
patients not giving consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess the ease of intubation |
to assess the ease of intubation using glottic score and cough score during bronchoscopy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to assess the degree of sedation between two groups using Ramsay sedation score.
to assess the hemodynamic parameters of patient preoperatively, during intubation and during the intra operative period.
to assess the complications encountered. |
to assess the degree of sedation between two groups using Ramsay sedation score during bronchoscopy.
to assess the hemodynamic parameters of patient preoperatively, during intubation and during the intra operative period.
to assess the complications encountered that is all end points are recorded during the procedure.. |
|
|
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 3 |
|
Date of First Enrollment (India)
|
20/11/2020 |
| 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="0"
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
|
difficulty in airway management during anaesthesia can lead to severe anaesthesia related morbidity and mortality. awake intubation now has become one of the recommended modality to manage airway that is expected to be difficult. fibreoptic bronchoscopy is a relatively safer method used now for the management of the same. comparasion between dexmedetomedine and ketamine nebulisation as an adjuvant to lignocaine for awake fiberoptic intubation could bring new insight in the area of awake intubations. |