| CTRI Number |
CTRI/2024/10/074790 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Eeffectiveness of Intravenous Versus Nebulized Ketamine-Dexmedetomidine Combination (Ketodex) in Awake Fiberoptic Intubationis compare. |
|
Scientific Title of Study
|
Comparison of efficacy of Intravenous Versus Nebulized Ketamine-Dexmedetomidine Combination (Ketodex) in Awake Fiberoptic Intubation |
| 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 Nabeeh N |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Bhopal |
| Address |
Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal Bhopal MADHYA PRADESH 462020 India |
| Phone |
8848287407 |
| Fax |
|
| Email |
Nabeehnalakath95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shikha Jain |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS BHOPAL |
| Address |
Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal Bhopal MADHYA PRADESH 462020 India |
| Phone |
7987164388 |
| Fax |
|
| Email |
Shikha.anaesth@aiimsbhopal.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Shikha Jain |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS BHOPAL |
| Address |
Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal Bhopal MADHYA PRADESH 462020 India |
| Phone |
7987164388 |
| Fax |
|
| Email |
Shikha.anaesth@aiimsbhopal.edu.in |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Bhopal, Madhya Pradesh, India 462020 |
|
|
Primary Sponsor
|
| Name |
Dr Shikha Jain |
| Address |
Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal |
| 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 Nabeeh N |
All india institute of medical sciences , Bhopal |
Department of Anaesthesiology, 3 rd floor,Trauma building ,
AIIMS Bhopal Bhopal MADHYA PRADESH |
8848287407
Nabeehnalakath95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee- Student Research (IHEC-SR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Ketamine 0.5mg/kg-Dexmedetomedine 1mcg/kg (Keto Dex) |
Intravenous Ketamine 0.5mg/kg, Dexmedetomidine(1mcg/kg)Keto Dex) in 20 ml of normal saline for 10 minutes,once,after standard pre nebulization with 8ml of 4% lignocaine for 40 minutes. |
| Comparator Agent |
Nebulization of Ketamine 0.5mg/kg-Dexmedetomidine 1 mcg/kg(Keto-Dex) |
Nebulization of Ketamine 0.5mg/kg-Dexmedetomidine 1 mcg/kg(Keto-Dex) in 8ml of 4% lignocaine for 40 minutes, followed by intravenous infusion of 20ml normal saline for 10 minutes during procedure. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the ASA physical status I or II according to the American Society of Anesthesiologists (ASA)
|
|
| ExclusionCriteria |
| Details |
1. Patients who refuse or uncooperative such as those with mental retardation, lack of communication, blindness, and deafness were excluded from the study.
2. Patients who had coagulation disorders, respiratory or pulmonary disorders, pregnancy or full stomach, increased intracranial pressure or intraocular pressure, and emergency surgeries or allergy to the drug used in the study or with risk for regurgitation–aspiration were excluded from the study​
|
|
|
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 |
1. Difference in time (sec) taken to intubate the patients during Awake Fiberoptic Intubation in both the groups
2. Difference in the ease of intubation with the help of intubation score (vocal cord movement, limb movement, and cough) at the time of entry of tip of endotracheal tube through the glottis.​
|
At the time of intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Difference in hemodynamic variables (Heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) in both the groups after starting the infusion every two minutes for 10 minutes.
2. Difference in Post-operative Patient satisfaction score & adverse effects after 24 hours post extubation |
1.After starting the infusion every two minutes for 10 minutes
2. After 24 hours post extubation |
|
|
Target Sample Size
|
Total Sample Size="68" Sample Size from India="68"
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 4 |
|
Date of First Enrollment (India)
|
07/10/2024 |
| 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 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
|
Awake fiber-optic intubation (AFOI) is considered as the standard option in dealing with the cases amongst anticipated difficult airway. Proper conscious sedation is paramount to increase the tolerability of the intubation and its success. An ideal sedative agent should be the one that provides better comfort and compliance ie, patientcooperation while maintaining haemodynamic stability and spontaneous ventilation,when being awake during the procedure. It may be difficult to choose appropriate sedative drugs due to their depressant effects on respiration. Intravenous is the most common route used for this purpose, However, the nebulized route is an attractive alternative as it can potentially avoid systemic side effects. Dexmedetomidine, an α2-adrenoreceptor agonist, is a very useful drug for fiberoptic intubation as it can produce sedation, analgesia and anxiolysis without causing respiratory depression. In addition, it can also cause xerostomia( decreased salivation) which can be utilized to counter act excessive salivation caused by the Ketamine. These two effects make dexmedetomidine highly desirable for awake fiberoptic nasotracheal intubation.(4) Unlike patients sedated with propofol, patients receiving dexmedetomidine are easily arousable without expressing irritation(5). The relative sympatholysis achieved during dexmedetomidine infusions is an additional benefit in a procedure that may lead to elevations of heart rate (HR) and blood pressure(6) Ketamine is a NMDA receptor antagonist,which provides sedation and analgesia along with its sympatho mimetic effects, at the same time causing excessive salivation or secretions. Hence combination of these two( ketamine & dexmeditomidine) can counteract side effects of each other, which can be utilised in AFOB. Low doses of ketamine added to dexmedetomidine provide an additional analgesic effect and assist avoid bradycardia and hypotension caused by dexmedetomidine,while dexmedetomidine attenuates the unfavourable rise in airway secretion brought by ketamine. Combining Ketamine and Dexmedetomidine will result in more steady hemodynamic response, greater sedation and easier intubation because Ketamine and Dexmedetomidine have opposing effects on cardiac autonomic receptors and the central nervous system. Therefore, this study aims to compare the efficacy of Intravenous Versus Nebulized Ketamine-Dexmedetomidine Combination (Ketodex) in Awake Fiberoptic Intubation |