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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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

 
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