| CTRI Number |
CTRI/2024/11/077470 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
22/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the effects of two sedative agents ketodex and ketofol during Awake Fiberoptic Intubation in patients for Cervical Spine Surgery. |
|
Scientific Title of Study
|
Comparison of intravenous ketofol (ketamine plus propofol) and ketodex (ketamine plus dexmedetomidine) sedation during awake fiberoptic intubation in patients for cervical spine surgery
A randomized control trial . |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Devyani Sharma |
| Designation |
Junior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
Fourth floor Nehru building
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160001
India |
| Phone |
8894112916 |
| Fax |
|
| Email |
Sharma.devyani31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Chauhan |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
Fourth floor Nehru building
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160001
India |
| Phone |
7087422950 |
| Fax |
|
| Email |
dr.rajeevchauhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Chauhan |
| Designation |
Associate Professor |
| Affiliation |
PGIMER Chandigarh |
| Address |
Department of Anaesthesia and Intensive Care
Fourth floor Nehru building
PGIMER Chandigarh
Chandigarh
CHANDIGARH
160001
India |
| Phone |
7087422950 |
| Fax |
|
| Email |
dr.rajeevchauhan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia
Fourth floor
Nehru building
PGIMER
Chandigarh
160001 |
|
|
Primary Sponsor
|
| Name |
Dr Devyani Sharma |
| Address |
Department of Anaesthesia and Intensive Care
Fourth floor Nehru building
PGIMER chandigarh
160001 |
| Type of Sponsor |
Other [self] |
|
|
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 Devyani |
PGIMER |
Department of Anaesthesia and Intensive Care
Fourth floor Nehru building
PGIMER Chandigarh
160001
Chandigarh
CHANDIGARH |
8894112916
Sharma.devyani31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research , Chandigarh Institutional Ethics committe (Intramural) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M469||Unspecified inflammatory spondylopathy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketodex ( ketamine
+ dexmedotomidine )will be used |
Patients will receive a bolus of ketodex (ketamine 0.25mg/kg, dexmedetomidine 0.5 mcg/kg/hr) followed by an infusion of ketodex (ketamine 0.25mg/kg/hr followed by dexmedetomidine 0.5 mcg/kg/hr). Fiberoptic intubation will be performed. The drug infusion duration will be till intubation is confirmed by capnography . After that the infusion drug will be discontinued. |
| Intervention |
ketofol (ketamine + propofol ) will be used |
Patients will receive bolus of ketofol (0.125ml/kg ) followed by low dose infusion of ketofol (0.125 ml/kg/hr ) and then fiberoptic intubation will be done .The drug
infusion duration will be till intubation is confirmed by capnography .Then the drug infusion will be discontinued . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
no anticipated difficult airway .
age group 18 to 65 years of both sexes .
BMI 18.5 -29.9 kg/m2
ASA 1 and 2 patients . |
|
| ExclusionCriteria |
| Details |
ASA 3 and 4 patients
Refusal of the patient
Pregnancy/bleeding disorder
Alcohol or substance abuse
presence of cardiac or respiratory disease
Psychological disturbance
any known allergy to the study drugs
coagulopathy
hepatic or renal impairment |
|
|
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 |
| Time taken from the start of the drug infusion till confirmation of intubation with capnography. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Number of patients requiring rescue drugs such as fentanyl
|
1 year |
| hemodynamic stability |
1 year |
| Patients tolerance to endoscopy and intubation |
1 year |
| patients satisfaction 24 hours post operation |
1 year |
| Anesthesiologist satisafaction |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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
|
It is a randomized control trial aimed at comparing the effects of ketodex and ketofol for awake fiberoptic intubation in patients for cervical spine surgery in terms of intubating conditions , hemodynamic stability and patients and anesthesiologists satisfaction . a total sample size of 50 patients will be taken in which 25 patients will recieve the drug infusion of ketofol and 25 patients will recieve the drug ketodex . The primary outcome is the the total time taken from start of infusion till confirmation in intubaion with capnography .The study will be done at PGIMER after CTRI registeration .
|