| CTRI Number |
CTRI/2020/11/029005 [Registered on: 10/11/2020] Trial Registered Prospectively |
| Last Modified On: |
28/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ketamine-dexmedetomidine nebulisation versus intravenous route for awake fibreoptic intubation |
|
Scientific Title of Study
|
Comparsion of nebulised ketamine-dexmedetomidine versus intravenous ketamine-dexmedetomidine for awake fibreoptic 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 Chaitra S |
| Designation |
Post Graduate Student |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesia
King George Medical University
lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8660197991 |
| Fax |
|
| Email |
chaitraar420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanmay Tiwari |
| Designation |
Associate professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesia
King George Medical University
lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9452526270 |
| Fax |
|
| Email |
tanmayanesthesia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tanmay Tiwari |
| Designation |
Associate professor |
| Affiliation |
King George Medical University |
| Address |
Department of Anaesthesia
King George Medical University lucknow 226003
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9452526270 |
| Fax |
|
| Email |
tanmayanesthesia@gmail.com |
|
|
Source of Monetary or Material Support
|
| King George Medical University |
|
|
Primary Sponsor
|
| Name |
Chaitra |
| Address |
Dept of anaesthesia,KGMU
Lucknow 226003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Tanmay tiwari |
king george medical university |
Department of anaesthesia
Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH |
9452526270
tanmayanesthesia@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KINK GEORGE MEDICAL UNIVERSITY |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine -dexmedethomidine |
Ketamine (0.5mg/kg)+dexmedetomidine(1mcg/kg) given through intravenous over 10mins with nebulisation with normal saline over 10mins in one group and same drugs through nebulisation over 10mins with normal saline intravenous over 10mins and given.drugs are given only once |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Pateints giving written informed consent will be taken.
2. Aged between 18-60years of both sex with ASA physical status I and II.
3. Patients with anticipated difficult airway undergoing elective surgical
procedures. |
|
| ExclusionCriteria |
| Details |
Any type of A-V block on electrocardiogram (ECG), heart failure, coronary heart disaese.
liver cirrhosis, thrombocytopenia and coagulopathies
severe bradycardia
current psychiatric disorder, history of seizures
any respiratory disorders
history of epistaxis, nasal pathology
known drug allergy to the study drugs
ASA III and ASA IV
pregnant female
Emergency procedures
Patient refusal |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Time required for intubation between group receiving dexmedetomidine+ketamine through intravenous route and group receiving dexmedetomidine+ketamine through nebulisation.
|
Time required for intubation is calculated when first reading obtained by capnograph after
entotracheal intubation. That is after 10mins of baseline till first capnograph reading.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the sedation score |
at the end of trial drug administration |
| cough severity |
while passing the fibreoptic bronchoscope |
| patient tolerance |
whicle performing the procedure |
| ease of intubation |
while passing the endotracheal tube through vocal cords |
| hemodynamic changes (HR,SBP,DBP,MAP,ECG,SPO2) |
baseline,2mins,4mins,6mins,8mins,10mins,fibreoptic through nostril,ETT through nasopharynx,ETT through glottis,5mins after intubation and 10mins after intubation |
| recall of events and discomfort during procedure |
postoperative period |
| adverse events |
postoperative period |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
15/11/2020 |
| 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
Modification(s)
|
64 patients are divided into two groups randomally.group 1 will receive ketamine -dexmedetomidine intravenous route with normal saline nebulisation over 10mins.group2 will receive ketamin-dexmedetomidine through mobilisation and normal saline intravenous. When the sedation Score is less or equal to 3,fibreoptic incubation is attempted. If score more that 3 propofol+ketamine(ketofol) 1ml containing 10mg propofol and 10mg ketamine is given and amount of it required is noted. Both the groups will receive premedications and transtracheal and superior laryngeal block. The time taken for incubation is compared among both the groups along with the secondary goals . |