| CTRI Number |
CTRI/2021/11/038037 [Registered on: 15/11/2021] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two different doses of intravenous ketamine (intravenous anesthetic agent) added to intravenous dexmedetomidine (sedative) for awake fibre optic nasotracheal intubation
|
|
Scientific Title of Study
|
Comparison of two different doses of intravenous ketamine added to intravenous dexmedetomidine for awake fibre optic nasotracheal intubation
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pratiksha Sutar |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology ,Goa Medical College ,Bambolim,Goa
Department of Anesthesiology ,Goa Medical College ,Bambolim,Goa
North Goa
GOA
403201
India |
| Phone |
7507402597 |
| Fax |
|
| Email |
pratiksha_sutar@ymail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohini Bhat Pai |
| Designation |
Consultant |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology ,Goa Medical College ,Bambolim,Goa
Department of Anesthesiology ,Goa Medical College ,Bambolim,Goa
North Goa
GOA
403201
India |
| Phone |
7741866436 |
| Fax |
|
| Email |
docpai@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pratiksha Sutar |
| Designation |
Junior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Anesthesiology ,Goa Medical College ,Bambolim,Goa
Department of Anesthesiology ,Goa Medical College ,Bambolim,Goa
North Goa
GOA
403201
India |
| Phone |
7507402597 |
| Fax |
|
| Email |
pratiksha_sutar@ymail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College and Hospital Bambolim,Goa |
|
|
Primary Sponsor
|
| Name |
Goa Medical College and Hospital |
| Address |
Goa Medical College and Hospital ,Bambolim,Goa |
| 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 Pratiksha Sutar |
Goa Medical College and Hospital, Operation Theatre ,(Lower and Upper OT) |
Trial /Procedure will be conducted in Upper and Lower operation theatre as per the cases posted under Department of Oro- maxillofacial surgery, ENT, General Surgery and Orthopedic Surgery.
Goa Medical College Bambolim,Panjim Goa
North Goa
GOA |
7507402597
pratiksha_sutar@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Goa Medical College Institutional Ethics Committee |
Approved |
|
|
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, (2) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Addition of intravenous ketamine to intravenous dexmedetomidine for awake fibre optic nasotracheal intubation |
Intravenous ketamine at two different doses will be administered to the patient during awake fribre optic nasotracheal intubation. |
| Comparator Agent |
Comparison between two different doses of ketamine (bolus vs infusion) will be assessed. |
One group of patients will receive 20mg of intravenous ketamine followed by 1mg/kg/hour infusion along with intravenous dexmedetomidine while other group will receive 40 mg of intravenous ketamine bolus along with intravenous dexmedetomidine . |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with predicted airway posted for surgery under general anaesthesia
ASA grade I and II
|
|
| ExclusionCriteria |
| Details |
1.Uncooperative patient/inability to communicate effectively
2.Pregnant women or patients requiring rapid sequence induction
3.Cardiopulmonary disease, heart rate (HR) <50 beats/min or any type of atrioventricular block on the electrocardiogram
4.Allergy to the drugs involved in the study
5.History of drug or alcohol abuse, and patients on long-term opioids or sedative medication
6.Contraindication for nasal intubation
7.Patients of difficult airway with impending airway obstruction
|
|
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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 and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess time taken for intubation on administration of two different doses of intravenous ketamine added to intravenous dexmedetomidine for awake fibre optic nasotracheal intubation |
To assess time taken for intubation on administration of two different doses of intravenous ketamine added to intravenous dexmedetomidine for awake fibre optic nasotracheal intubation from the point of introduction of the bronchoscope into the nares of the patient until securing the nasotracheal tube at the level of carina (which will be confirmed by direct visualization of trachea and carina using bronchoscope and capnography to exclude esophageal intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessing variation in following parameters ie heart rate, Systolic blood pressure, Diastolic blood pressure, Mean Arterial pressure, Oxygen Saturation during the procedure of awake fibreoptic bronchoscope guided nasotracheal intubation.
|
At following points above parameters will be measured ,besides time taken to reach these points will also be recorded
1.After insertion of scope
2.Scope at nasopharynx
3.Scope at Glottis
4.After intubation
1min
5min
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
22/11/2021 |
| Date of Study Completion (India) |
23/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
22/09/2022 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The purpose of this study to compare different doses of intravenous ketamine (20mg followed by infusion of 1mg/kg/hour vs 40mg bolus dose) added to intravenous dexmeditomidine for smooth and with less hemodynamic disturbances for awake fibreoptic nasotracheal intubation . |