| CTRI Number |
CTRI/2024/10/075234 [Registered on: 14/10/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Ease of i-gel insertion with dexmedetomidine or fentanyl along with propofol and hemodynamic variability |
|
Scientific Title of Study
|
Comparative evaluation of i-gel insertion conditions using dexmedetomidine versus fentanyl - A randomised controlled 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 |
Sindhura |
| Designation |
JR 1 |
| Affiliation |
sri devaraj urs medical college |
| Address |
department of anaesthesiology,
sri devaraj urs medical college, tamaka, kolar
563103
Kolar
KARNATAKA
563103
India |
| Phone |
8106671679 |
| Fax |
|
| Email |
dr.sindhura3456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Kiran N |
| Designation |
The professor |
| Affiliation |
shri devaraj urs medical college |
| Address |
department of anaesthesiology
sri devaraj urs medical college,tamAKA,KOLAR
563103
Kolar
KARNATAKA
563103
India |
| Phone |
9740468460 |
| Fax |
|
| Email |
Dr.nkiran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sindhura |
| Designation |
JR 1 |
| Affiliation |
shri devaraj urs medical college |
| Address |
deparment of anaesthesiology,
sri devaraj urs medical college, tamaka,kolar
563103
KARNATAKA
563103
India |
| Phone |
8106671679 |
| Fax |
|
| Email |
dr.sindhura3456@gmail.com |
|
|
Source of Monetary or Material Support
|
| shi devaraj urs medical college, RL JALAPPA HOSPITAL, tamaka, kolar, karnataka |
|
|
Primary Sponsor
|
| Name |
shri devaraj urs medical college |
| Address |
department of anaesthesia, shri devaraj urs medical college, Tamaka, Kolar,563103. |
| Type of Sponsor |
Private 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 Sindhura |
shri devaraj urs medical college |
Department of anaesthesia,
shri devaraj urs medical college
Tamaka, Kolar
Kolar
KARNATAKA |
8106671679
dr.sindhura3456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri devaraj urs medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexmedetomidine and fentanyl |
ease of i gel insertion by using one of the drug, Dexmedetomidine 1uglkg diluted to 10ml with ns, fentanyl- 1ug/kg diluted to 5ml with ns, frequency for both drugs is 1 time, total time is during insertion approxmately 15-20 minutes |
| Intervention |
evaluation of i-gel® insertion conditions using
dexmedetomidine versus fentanyl |
Patients baseline parameters such as heart rate, Electrocardiogram (ECG), mean arterial pressure,
respiratory rate and oxygen saturation will be noted upon arrival to the operation theatre and monitored
continuously thereafter. Intravenous access will be secured with 18G cannula and Ringers lactate
solution at 2 ml/kg/hr will be started. Oxygen will be administered via nasal cannula at 2 L/min to
prevent de- saturation during study drug infusion over ten minutes. Premedication with IV Injection
Glycopyrrolate 0.004 mg/kg will be given.
 Group D will receive 1 μg/kg dexmedetomidine diluted to 10 ml with 0.9% NS
ï‚· Group F will receive 10 ml of NS over 10 minutes followed by injenction fentanyl 1ug/kg
diluted to 5ml with 0.9% NS over 2 minutes
Thirty seconds after the injection of study drugs, anaesthesia will be induced with 2 mg/kg of
injection propofol later I gel insertion will be attempted |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective surgeries under general anaesthesia
Age: 18 -60 years.
ASA physical status 1 or 2 |
|
| ExclusionCriteria |
| Details |
1. Severe respiratory or cardiac disorders, hepatic or renal insufficiency, coagulopathy.
2. Allergy to any of the study drug (Test dose to be given).
3. Pregnancy or breast feeding.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess ease of I gel insertion using youngs criteria, lund and stoyener grading |
to assess ease of I gel insertion using youngs criteria, lund and stoyener grading |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess overall condition of I gel insertion using modified scheme of lund & stovner |
base line haemodynamic parameter such as heart rate,blood pressure, respiratory rate. before insertion & 1,3,5and 10 minutes after insertion |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/10/2024 |
| 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="4"
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
|
The study is to compare the conditions under which an i-gel® (a type of supraglottic airway device) is inserted when patients are administered dexmedetomidine versus fentanyl. This randomized controlled trial aims to determine which sedative agent provides better insertion conditions.
Dexmedetomidine, known for its sedative and analgesic properties, is compared to fentanyl, a potent opioid analgesic. The primary focus is on the ease of i-gel® insertion, as well as any differences in patient outcomes, such as comfort and hemodynamic stability. The results of the study would help in choosing the most effective sedative agent to improve the success and safety of i-gel® insertion in clinical settings. |