| CTRI Number |
CTRI/2024/07/071493 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two ways (Intravenous and Nebulization) for giving a combination of two drugs
(Dexmedetomidine and Ketamine) for passing tube (Endotracheal tube ) via nose with help of fiber scope in awake patients undergoing surgery |
|
Scientific Title of Study
|
Comparison Between Intravenous Versus Nebulized Routes For Administering Dexmedetomidine And Ketamine Combination To Assist Awake Fiberoptic Intubation A Prospective Randomised Double Blind Study |
| 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 Sandeep Sharma |
| Designation |
Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia, R.N.T Medical College, Udaipur,Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
09214323557 |
| Fax |
|
| Email |
sharma0979@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Sharma |
| Designation |
Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia, R.N.T Medical College, Udaipur,Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
09214323557 |
| Fax |
|
| Email |
sharma0979@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Agrawal |
| Designation |
Pg Resident |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia, R.N.T Medical College, Udaipur,Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
08619669978 |
| Fax |
|
| Email |
sakshiagrawal374@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
R.N.T Medical College , Udaipur 313001
Rajasthan , India |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
Department of Anaesthesia, R.N.T Medical College,
Udaipur 313001
Rajasthan , India |
| Type of Sponsor |
Government medical college |
|
|
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 Sakshi Agrawal |
Maharana Bhupal Government Hospital |
2nd Floor Main Building ENT OT and 5th Floor SSB Building Neurosurgery OT, R.N.T Medical College , Udaipur
Udaipur
RAJASTHAN |
8619669978
sakshiagrawal374@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RNT MEDICAL COLLEGE AND CONTROLLER AND ATTACHED HOSPITALS UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H720||Central perforation of tympanic membrane, (2) ICD-10 Condition: H711||Cholesteatoma of tympanum, (3) ICD-10 Condition: H712||Cholesteatoma of mastoid, (4) ICD-10 Condition: H701||Chronic mastoiditis, (5) ICD-10 Condition: M265||Dentofacial functional abnormalities, (6) ICD-10 Condition: M266||Temporomandibular joint disorders, (7) ICD-10 Condition: M402||Other and unspecified kyphosis, (8) ICD-10 Condition: G544||Lumbosacral root disorders, not elsewhere classified, (9) ICD-10 Condition: G892||Chronic pain, not elsewhere classified, (10) ICD-10 Condition: C73||Malignant neoplasm of thyroid gland, (11) ICD-10 Condition: M243||Pathological dislocation of joint,not elsewhere classified, (12) ICD-10 Condition: M433||Recurrent atlantoaxial dislocationwith myelopathy, (13) ICD-10 Condition: M500||Cervical disc disorder with myelopathy, (14) ICD-10 Condition: M511||Thoracic, thoracolumbar and lumbosacral intervertebral disc disorders with radiculopathy, (15) ICD-10 Condition: S121||Fracture of second cervical vertebra, (16) ICD-10 Condition: S220||Fracture of thoracic vertebra, (17) ICD-10 Condition: S129||Fracture of neck, unspecified, (18) ICD-10 Condition: S320||Fracture of lumbar vertebra, (19) ICD-10 Condition: S024||Fracture of malar, maxillary and zygoma bones, (20) ICD-10 Condition: S342||Injury of nerve root of lumbar andsacral spine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AWAKE FIBEROPTIC INTUBATION |
Comparison Between IV Dexmedetomidine (1 microgram/kg) with Ketamine (0.5 milligram/kg)
Vs Nebulized Dexmedetomidine (1 microgram/kg) with Ketamine (0.5 milligram/kg) On Intubating Conditions During Awake Fiberoptic Intubation |
| Comparator Agent |
IV Dexmedetomidine with Ketamine in Awake Fiberoptic Intubation |
Intravenous Dexmedetomidine (1 microgram/kg) plus Ketamine (0.5 millligram/kg) diluted in 50 ml normal saline over 15 minutes along with Nebulized 4 ml of 4% Lignocaine diluted to total volume 5.5 ml for 20 minutes just before awake fiberoptic intubation |
| Comparator Agent |
Nebulized Dexmedetomidine with Ketamine in Awake Fiberoptic Intubation |
Nebulized Dexmedetomidine (1 microgram/kg) plus Ketamine (0.5 millligram/kg) plus 4 ml of 4% Lignocaine diluted to total volume 5.5 ml for 20 minutes along with 50 ml normal saline intravenous infusion over 15 minutes just before awake fiberoptic intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA physical status Grade I and II
Patients undergoing elective surgery under general endotracheal anesthesia
Patients with Mallampati Class I and II |
|
| ExclusionCriteria |
| Details |
Patient refusal
Psychiatric patients
Emergency surgery
Patients with severe bradycardia /heart block
Pregnant and lactating mothers
Patients having known allergy to any drugs used in the study
Patients on long-term opioids or sedative medications
Patients contraindicated to nasal intubation such as grossly distorted airway anatomy ,URTI and bleeding disorders
|
|
|
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 |
| Cough score (severity of cough) during awake fiberoptic intubation |
Up to 2 Min after awake fiberoptic intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intubating condition
Vocal cord position
Post intubation score
Ramsay sedation score
Hemodynamic parameters
Side effects /Complication if any
|
Up to 24- Hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
08/08/2024 |
| 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="0"
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
|
We would like to compare Intravenous and Nebulized routes for giving Dexmedetomidine with Ketamine on intubating conditions during awake fiberoptic intubation in terms of cough score, intubating condition, Ramsay sedation score, hemodynamic parameters , side effects / complications if any. Kindly grant CTRI registration for our study as IV Dexmedetomidine with ketamine and Nebulized Dexmedetomidine are FDA approved drugs. |