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CTRI Number  CTRI/2025/04/083935 [Registered on: 02/04/2025] Trial Registered Prospectively
Last Modified On: 17/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study compares two ways of giving sedation—one with inhaled dexmedetomidine and IV ketamine, the other with inhaled ketamine and IV dexmedetomidine—to see which works better for keeping patients calm and comfortable during a breathing tube placement for jaw and mouth surgery. 
Scientific Title of Study   Nebulized Dexmedetomidine and Intravenous Ketamine Versus Nebulized Ketamine and Intravenous Dexmedetomidine to facilitate Awake Fiberoptic Nasotracheal Intubation in adult patients undergoing Oromaxillofacial surgeries - A randomized double blind study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Moinul Haque 
Designation  Junior Resident(Academic) 
Affiliation  AIIMS Bhopal 
Address  Department of Anaesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar, Bhopal, MADHYA PRADESH 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  8209625686  
Fax    
Email  moinulhaque567@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S R A N Bhushanam Padala 
Designation  Associate Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anaesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar,Bhopal Madhya Pradesh 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala.anesth@aiimsbhopal.edu.in  
 
Details of Contact Person
Public Query
 
Name  Dr S R A N Bhushanam Padala 
Designation  Associate Professor 
Affiliation  AIIMS Bhopal 
Address  Department of Anaesthesia and critical care,3rd floor hospital building,AIIMS Bhopal,Saket Nagar,Bhopal Madhya Pradesh 462020 India

Bhopal
MADHYA PRADESH
462020
India 
Phone  7893562302  
Fax    
Email  padala.anesth@aiimsbhopal.edu.in  
 
Source of Monetary or Material Support  
AIIMS, Saket nagar, Bhopal, Madhya Pradesh, India, PIN-462020(non funded) 
 
Primary Sponsor  
Name  Dr S R A N Bhushanam Padala 
Address  Department of Anesthesiology and critical care,3rd floor hospital building,AIIMS Saket Nagar,Bhopal Madhya Pradesh 462020 India 
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 Moinul Haque  AIIMS Bhopal  Dental ot(ot-10),2nd floor modular ot complex,hospital building ,AIIMS Bhopal,Saket Nagar Bhopal Madhya Pradesh 462020 India
Bhopal
MADHYA PRADESH 
8209625686

moinulhaque567@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Bhopal 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: D164||Benign neoplasm of bones of skulland face,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nebulization dexmedetomidine and intravenous ketamine  Nebulization: 4% Lignocaine - 5ml + Dexmedetomidine 1 mcg/kg diluted with 0.9% normal saline to make it to 7ml Intravenous: Inj. Ketamine 0.5mg/kg diluted in 20 ml with 0.9% normal saline over 10 min 
Comparator Agent  Nebulization ketamine and intravenous dexmedetomidine  Nebulization: 4% Lignocaine - 5ml + Ketamine 0.5 mg/kg diluted with 0.9% normal saline to make it to 7ml Intravenous: Inj. Dexmeditomidine 1mcg/kg diluted in 20ml with 0.9% normal saline over 10 min 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Individuals aged between 18 and 65 years scheduled for elective Oromaxillofacial surgery.
2.Patients classified as American society of Anesthesiologists(ASA) physical status 1 and 2
3.Patients with predicted difficult airway (defined as mouth opening less than 2.5 cm, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, or modified Mallampati class III/IV) who are candidates for AFNI 
 
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 study drugs 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, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the ease of intubation with the help of intubation score between the groups   During intubation 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the difference in time taken to intubate the patients during Awake Fiberoptic Intubation in both the groups  During intubation 
To assess the hemodynamic variables (Heart rate (HR), mean arterial pressure (MAP), and peripheral oxygen saturation (SpO2) in both the groups  T1 – Baseline (before starting nebulization)
T2 – before starting IV study drug infusions
T3 - 5 min after starting IV study drug infusions
T4 - at the end of IV study drug infusions
T5 – at the end of nasotracheal intubation
T6 – 5 min after nasotracheal intubation
T7 – 10 min after nasotracheal intubation 
To assess the Post-operative Patient satisfaction score, Recall of procedure  During postoperative period 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   15/04/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 fiberoptic nasotracheal intubation is a preferred method for managing patients with anticipated difficult airways. The success of this procedure largely depends on the sedative and analgesic regimen, which must ensure the patient remains comfortable and cooperative while maintaining airway safety and reflex suppression during the procedure.Commonly used sedatives in AFOI include benzodiazepines, sevoflurane, remifentanil, ketamine, propofol, and dexmedetomidine.
Previously combination of drugs have been used for AFOI to counteract each others adverse effects. Dexmedetomidine, an  alpha 2 adrenoreceptor agonist, is an ideal choice for AFOI because it provides sedation, analgesia, and anxiolysis without significantly impairing respiratory function, which is essential for maintaining spontaneous breathing during the procedure. Additionally, dexmedetomidine can reduce salivation, which helps counteract the excessive salivation caused by ketamine during sedation.
A key advantage of dexmedetomidine is that it allows patients to remain easily arousable without agitation, unlike sedatives like propofol that may cause deeper sedation and respiratory suppression. This makes dexmedetomidine especially useful, as patients can be more easily engaged during the procedure without irritation. The relative sympatholysis achieved during dexmedetomidine infusions is an additional benefit in a procedure that may lead to elevations of heart rate and blood pressure. Nebulisation with dexmedetomidine compared to intravenous results in desirable degree of sedation and better tolerance of the procedure with adequate attenuation of the haemodynamic responses to intubation.
Ketamine, an NMDA receptor antagonist, provides both sedation and pain relief while stabilizing hemodynamics through its sympathomimetic effects, such as increasing heart rate and blood pressure. However, ketamine can also increase airway secretions, which can complicate the intubation process by making it harder to visualize the airway and increasing the risk of aspiration. Managing this side effect is crucial for a successful procedure.
Using ketamine and dexmedetomidine together offers a synergistic approach that addresses the limitations of each drug. While ketamine offers effective analgesia and sedation with sympathomimetic effects, dexmedetomidine helps control the increased secretions caused by ketamine and prevents the rise in heart rate and blood pressure that ketamine can induce. This combination leads to more stable hemodynamics, deeper sedation, and an easier intubation process.
In summary, combining ketamine and dexmedetomidine during awake fiber-optic intubation offers a balanced and effective approach to sedation and analgesia and we aim to compare different route combinations between them.
 
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