| 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. |
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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 |
|
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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 |
|
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Source of Monetary or Material Support
|
| AIIMS, Saket nagar, Bhopal, Madhya Pradesh, India, PIN-462020(non funded) |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Regulatory Clearance Status from DCGI
|
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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. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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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 |
|
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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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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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. |