| CTRI Number |
CTRI/2024/09/074528 [Registered on: 30/09/2024] Trial Registered Prospectively |
| Last Modified On: |
17/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of Low-Dose Ketamine with Lignocaine vs. Dexmedetomidine for Safe and Comfortable Breathing Tube Placement in Patients with Difficult Airways |
|
Scientific Title of Study
|
Comparison of effect of Subanesthetic dose of Intravenous Ketamine + Lignocaine versus Intravenous Dexmedetomidine on the intubating conditions and hemodynamic stability in awake fiberoptic intubation for anticipated difficult airway: a randomized clinical 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. Tarun Ponugoti |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
9515195751 |
| Fax |
|
| Email |
tarunponugoti14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Jitendra Kalbande |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8368326094 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Jitendra Kalbande |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur
Raipur
CHHATTISGARH
492099
India |
| Phone |
8368326094 |
| Fax |
|
| Email |
drjitu222@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology, All India Institute of Medical Sciences, Raipur |
|
|
Primary Sponsor
|
| Name |
Dr Tarun Ponugoti |
| Address |
Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur |
| 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 |
| Tarun Ponugoti |
All India Institute of Medical Sciences Raipur |
Department of Anesthesiology, Operation theatre complex, B block, 4th floor
Raipur
CHHATTISGARH |
9515195751
tarunponugoti14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
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: T888||Other specified complications of surgical and medical care, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
1 mcg/kg bolus over 10 mins intravenousfollowed by 0.2-0.7 mcg/kg/hr infusion intravenously until the procedure of fiberoptic intubation is completed |
| Intervention |
Ketamine, Lignocaine |
Ketamine- 0.3 mg/kg bolus intravenous followed by 0.3 mg/kg/hr infusion intravenously until the procedure of fiberoptic intubation is completed
Lignocaine- 1.5 mg/kg bolus intravenous followed by 1.5 mg/kg/hr infusion intravenously until the procedure of fiberoptic intubation is completed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for elective surgeries
2.Patients with ASA status of 1 and 2
3.Patients with Anticipated Difficult Airway with El‑Ganzouri Score
4–12 |
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to give consent for the study
2. Patients with contraindications for awake fiberoptic intubation such as history of coagulopathies, base of skull fracture
3. Patients allergic to study medications
4. Patients with coexisting diseases like uncontrolled hypertension, asthma, history of MI,CAD, shock, heart blocks, heart failure
5. Pregnant women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubating conditions in terms of Modified Observer Assessment of Alertness/Sedation(OAA/S) score,Endoscopy time, Intubation time, Endoscopist satisfaction score,Patient Discomfort score, Patient Recall of procedure |
OAA/S score-Immediately before intubation
Endoscopy time-from insertion of scope to carina visualization
Intubation Time-from ET tube insertion to fiberscope is removed
Endoscopist satisfaction-immediately after intubation
Patient Discomfort score- During intubation
Patient recall- 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic Parameters(Heart rate, Mean Arterial Pressure, Oxygen Saturation) |
Baseline, after achieving desired sedation level, 1 minute intervals during the procedure, immediately after securing the endotracheal tube |
| Opioid requirement during procedure |
End of the procedure |
| Incidence of adverse events |
24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
01/10/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
This study investigates the comparative effects of
subanesthetic intravenous (IV) ketamine plus lignocaine versus IV
dexmedetomidine on intubating conditions and hemodynamic stability during awake
fiberoptic intubation (AFOI) for anticipated difficult airways. The study is a
randomized, triple-blinded clinical trial involving 68 patients aged 18-60 with
anticipated difficult airways. Participants will be assigned to receive either
a combination of IV ketamine (0.3 mg/kg bolus followed by 0.3 mg/kg/hr
infusion) and lignocaine (1.5 mg/kg bolus followed by 1.5 mg/kg/hr infusion) or
IV dexmedetomidine (1 mcg/kg over 10 minutes followed by 0.2-0.7 mcg/kg/hr
infusion). Primary outcomes include the effectiveness of achieving optimal
intubating conditions, assessed by Modified Observer’s Assessment of
Alertness/Sedation (OAA/S), endoscopy and intubation times, endoscopist
satisfaction, and patient discomfort. Secondary outcomes include hemodynamic
parameters, opioid requirements, and incidence of adverse events. The study
aims to determine if the ketamine-lignocaine combination offers superior
intubating conditions and better hemodynamic stability compared to
dexmedetomidine. |