| CTRI Number |
CTRI/2025/09/095090 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two injectable drug combination(Dexmedetomidine-Ketamine and Magnesium sulphate-Ketamine)for passing tube (Endotracheal tube) via nose with help of video in awake patients. |
|
Scientific Title of Study
|
"Comparison of Dexmedetomidine - Ketamine and Magnesium Sulphate - Ketamine Combination as a Sedation for Awake Fibreoptic Intubation in Adult Patients Undergoing Elective Surgeries Under General Anesthesia: A Prospective Randomised Double - Blinded 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 Santosh Choudhary |
| Designation |
Associate Professor |
| Affiliation |
R.N.T Medical college |
| Address |
Department of Anesthesia, R.N.T medical college, Udaipur, Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
9462102856 |
| Fax |
|
| Email |
drsanchoudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Choudhary |
| Designation |
Associate Professor |
| Affiliation |
R.N.T Medical college |
| Address |
Department of Anesthesia, R.N.T medical college, Udaipur, Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
9462102856 |
| Fax |
|
| Email |
drsanchoudhary@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrG Manisha |
| Designation |
PG Resident |
| Affiliation |
R.N.T Medical College |
| Address |
Department of anesthesia, R.N.T mediacl college, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313001
India |
| Phone |
9952479443 |
| Fax |
|
| Email |
drmanisha1106@gmail.com |
|
|
Source of Monetary or Material Support
|
| RNT Medical College Department of Anesthesiology, Udaipur, Rajasthan 313001, India |
|
|
Primary Sponsor
|
| Name |
Maharana Bhupal Government Hospital |
| Address |
Department of anesthesia, R.N.T medical college, Udaipur, Rajasthan 313001, 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 Santosh Choudary |
Maharana Bhupal Government Hospital |
SSB OT 5th floor, Super Specialty Block, RNT Medical College
Udaipur
Rajasthan
Udaipur
RAJASTHAN |
9462102856
drsanchoudhary@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: O||Medical and Surgical, (2) ICD-10 Condition: S320||Fracture of lumbar vertebra, (3) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (4) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (5) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (6) ICD-10 Condition: S499||Unspecified injury of shoulder andupper arm, (7) ICD-10 Condition: K403||Unilateral inguinal hernia, with obstruction, without gangrene, (8) ICD-10 Condition: K420||Umbilical hernia with obstruction,without gangrene, (9) ICD-10 Condition: K458||Other specified abdominal hernia without obstruction or gangrene, (10) ICD-10 Condition: K36||Other appendicitis, (11) ICD-10 Condition: K819||Cholecystitis, unspecified, (12) ICD-10 Condition: N649||Disorder of breast, unspecified, (13) ICD-10 Condition: S129||Fracture of neck, unspecified, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AWAKE FIBREOPTIC INTUBATION |
Comparison between IV Dexmedetomidine-Ketamine and Magnesium sulphate-Ketamine on Intubating conditions during Awake Fibreoptic Intubation |
| Comparator Agent |
IV Dexmedetomidine-ketamine in Awake fibreoptic intubation |
Intravenous Dexmedetomidine (Loading dose 1mcg/kg in 100ml NS over 10 mins and maintenance dose 0.5mcg/kg in 100ml NS over 1hr after loading dose) - Katamine(0.5mg/kg) just before awake fibreoptic intubation |
| Comparator Agent |
IV Magnesium sulphate-ketamine in Awake Fibreoptic Intubation |
Intravenous Magnesium Slphate (Loading dose 40mg/kg in 100ml NS over 10 mins and maintenance dose 10mg/kg in 100ml NS over 1 hr after loading dose) - Ketamine (0.5mg/kg) just before awake fibreoptic intubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA Physical Status I and II, Patients with Mallampati Class I and II |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients with history of allergy to study drugs
Pregnancy and Lactation
Patienst with nasal infection, complete obstruction and any contraindication to nasal intubation
Patient with history of unstable angina or myocardial infarction and complete heart block
Patients with any known cardiac, respiratory, renal or hepatic disease
Psychiatric or neurological disease or seizure disorder
Patients with history of 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 fibreoptic intubation |
During awake fibreoptic intubation(2 mins) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intubation comfort score
POst intubation behaviour score/assessment
Postoperative patient satisfaction score
Ramsay sedation scale score
Haemodynamics
Side effects, complications if any |
Upto 6-hour post operatively |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
10/10/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 dexmedetomidine-ketamine and intravenous magnesium sulphate-ketamine on intubating conditions during awake fibreoptic intubation in terms of cough score, intubating conditions, post intubation behaviour score or assessment, postoperative patient satisfaction score, ramsay sedation scale score, haemodynamics, side effects or complications if any. Kindly grant CTRI registration for our study as dexmedetomidine, ketamine and magnesium sulphate are FDA approved drugs. |