| CTRI Number |
CTRI/2024/07/070076 [Registered on: 05/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of inhaled ketamine-lignocaine vs nalbuphine-nignocaine on intubation conditions and heart/blood pressure responses while inserting a endotracheal tube while the patient is awake, using a flexible camera.
|
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Scientific Title of Study
|
Comparison of Nebulized Ketamine-Lignocaine versus Nalbuphine-Lignocaine inhalation on intubating conditions and hemodynamic responses during Awake Fiberoptic Intubation |
| 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. Mukesh sirvi |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Anesthesia, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8866589866 |
| Fax |
|
| Email |
Mukeshsirvi07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Surendra Kr Jangid |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Anesthesia, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8560919243 |
| Fax |
|
| Email |
dr.skjangid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Surendra Kr Jangid |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Anesthesia, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8560919243 |
| Fax |
|
| Email |
dr.skjangid@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences,Raebareli |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli |
| Type of Sponsor |
Government medical college |
|
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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 Mukesh sirvi |
All India Institute of Medical Sciences, raebareli |
Dept of Anesthesia, 2nd Floor, All India Institute of Medical Sciences, Dalmau Road, Munshiganj, Raebareli
Rae Bareli
UTTAR PRADESH |
8866589866
mukeshsirvi07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bioethics cell All India Institute of medical sciences Raebareli |
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: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group LK (1 ml of ketamine 1 mg/Kg + 4 ml of 4% lignocaine) via nebulisation route for 30 mins of duration prior to awake fiberoptic intubation.
|
Patients from each group will undergo nebulization with 5 ml of 1 ml of ketamine 1 mg/Kg + 4 ml of 4% lignocaine via a nebulizer mask with a flow rate of 5 liters per minute for 30 minutes in the preoperative area. The nebulization process will be conducted by an independent anaesthesiologist not involved in the study to ensure blinding.Grimace score and sedation score will be observed just at the time of probe passage through the nostrils. Cough score will be noted at the time of probe passing through the glottis. Hemodynamic variables will be assessed at baseline, every 5 min after starting of nebulization for 30 minutes, at the beginning of FOB insertion, immediately after intubation, & 5 min after intubation. Secondary objectives such as time taken from the nostril till capnography trace on anesthetic work station will be noted. Patient satisfaction score will be noted during the postoperative period. |
| Comparator Agent |
Group LN (1 ml of 0.1 mg/kg of nalbuphine + 4 ml of 4% lignocaine) via nebulisation route for 30 mins of duration prior to awake fiberoptic intubation. |
Patients from each group will undergo nebulization with 5 ml of 1 ml of 0.1 mg/kg of nalbuphine + 4 ml of 4% lignocaine via a nebulizer mask with a flow rate of 5 liters per minute for 30 minutes in the preoperative area. The nebulization process will be conducted by an independent anaesthesiologist not involved in the study to ensure blinding.Grimace score and sedation score will be observed just at the time of probe passage through the nostrils. Cough score will be noted at the time of probe passing through the glottis. Hemodynamic variables will be assessed at baseline, every 5 min after starting of nebulization for 30 minutes, at the beginning of FOB insertion, immediately after intubation, & 5 min after intubation. Secondary objectives such as time taken from the nostril till capnography trace on anesthetic work station will be noted. Patient satisfaction score will be noted during the postoperative period. |
| Intervention |
Nebulization with lignocaine with different adjuvants prior to fibreoptic intubation |
Patients will be randomly allocated into two groups namely, group LN (1 ml of 0.1 mg/kg of nalbuphine + 4 ml of 4% lignocaine) or group LK (1 ml of ketamine 1 mg/Kg + 4 ml of 4% lignocaine). Randomization and blinding will be accomplished by the computer produced table of random numbers and closed envelopes. Patients from each group will undergo nebulization route with 5 ml of the study solution according to alloted to study group via a nebulizer mask with a flow rate of 5 liters per minute for 30 minutes in the preoperative area. Baseline hemodynamic parameters such as pulse rate, blood pressure, oxygen saturation (SpO2), and sedation score will be recorded. These parameters will be documented at five-minute intervals until tracheal intubation is completed. The primary outcome will be measured in terms of grimace score, sedation score (Ramsay sedation scale) and cough score. Grimace score and sedation score will be observed just at the time of probe passage through the nostrils. Cough score will be noted at the time of probe passing through the glottis. Hemodynamic variables will be assessed at baseline, every 5 min after starting of nebulization for 30 minutes, at the beginning of FOB insertion, immediately after intubation, & 5 min after intubation.
Secondary objectives such as time taken from the nostril till capnography trace on anesthetic work station will be noted. Patient satisfaction score will be noted during the postoperative period.
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anaesthesiology grade I and II
2. Patients suspected to have difficult intubation requiring fibreoptic as an aid
|
|
| ExclusionCriteria |
| Details |
1.Pregnancy
2.Coagulopathy (Bleeding airway)
3.Cerebrovascular disease
4.systemic infection
5.Inability to understand the study protocol
6.Allergy to either of the drugs ketamine/nalbuphine/lignocaine
7.Psychopathy that may affect patient evaluation
8.Patient refusal
9.Pateints with significant renal, hepatic, pulmonary and neurological diseases
10.Pateints with history of drug abuse
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To Compare the facial grimace scores, cough scores, sedation score between the groups
To compare the hemodynamic parameters among the two groups
|
24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Compare Time taken for AFOI and Patient satisfaction scores in both the groups |
12 hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
23/07/2024 |
| 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="1" |
|
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
|
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Brief Summary
|
This study is a randomized, double blind trial comparing compare the efficacy of ketamine and nalbuphine with lignocaine in blunting the hemodynamic response during Awake Fibreoptic Intubation that is being conducted at AIIMS Raebareli. The primary outcome is to compare the facial grimace scores, cough scores and sedation score between the groups as well as tp compare the hemodynamic parameters among the two groups. |