| CTRI Number |
CTRI/2025/07/091540 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Effects Of Dexmedetomidine drug group And Fentanyl drug group On Insertion Of i-Gel In Patients planned for Surgery Under full General Anaesthesia |
|
Scientific Title of Study
|
Effects Of Dexmedetomidine And Fentanyl On Insertion Of i-Gel In Patients Undergoing Surgery Under General Anaesthesia- A Randomized Clinical 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 |
A SUDARSHAN |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology, REGIONAL INSTITUTE OF MEDICAL SCIENCES
IMPHAL
MANIPUR
Imphal West
MANIPUR
795004
India |
| Phone |
9676109140 |
| Fax |
|
| Email |
sudarshanambati5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N RATAN SINGH |
| Designation |
PROFESSOR |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology, REGIONAL INSTITUTE OF MEDICAL SCIENCES
IMPHAL
MANIPUR
Imphal West
MANIPUR
795004
India |
| Phone |
9436027270 |
| Fax |
|
| Email |
drnratansingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N RATAN SINGH |
| Designation |
PROFESSOR |
| Affiliation |
REGIONAL INSTITUTE OF MEDICAL SCIENCES |
| Address |
Department of Anaesthesiology, REGIONAL INSTITUTE OF MEDICAL SCIENCES
IMPHAL
MANIPUR
Imphal West
MANIPUR
795004
India |
| Phone |
9436027270 |
| Fax |
|
| Email |
drnratansingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY
REGIONAL INSTITUTE OF MEDICAL SCIENCES IMPHAL
IMPHAL WEST
MANIPUR
Pin 795004 |
|
|
Primary Sponsor
|
| Name |
A SUDARSHAN |
| Address |
REGIONAL INSTITUTE OF MEDICAL SCIENCES
IMPHAL
IMPHAL WEST
MANIPUR
Pin 795004
|
| Type of Sponsor |
Other [POST GRADUATE TRAINEE] |
|
|
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 |
| sudarshan ambati |
REGIONAL INSTITUTE OF MEDICAL SCIENCES, IMPHAL, MANIPUR |
ELECTIVE SURGERY OPERATION THEATRE COMPLEX
DEPARTMENT OF ANAESTHESIOLOGY
REGIONAL INSTITUTE OF MEDICAL SCIENCES
IMPHAL
MANIPUR
Imphal West
MANIPUR |
9676109140
sudarshanambati5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board Regional Institute of Medical Sciences Imphal Manipur |
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 |
| Intervention |
Dexmedetomidine 0.5mcg/kg |
Study participants will be randomized into two groups.
Intervention group will receive 0.5mcg/kg Dexmedetomidine before induction |
| Comparator Agent |
Fentanyl 1mcg/kg |
Study participants will be randomized into two groups.
Intervention group will receive fentanyl 1mcg/kg before induction |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients aged between 18-60 years
2. American Society of Anaesthesiologists Physical Status 1 & 2
3. Patients undergoing general anaesthesia for elective surgical procedures |
|
| ExclusionCriteria |
| Details |
1.Patients not willing to participate in the study
2. Patients with reduced mouth opening
3. Neck and Facial burns and contracures
4. Modified Mallampati class more than 3
5. Body Mass Index more than 30
6. Thyromental distance less than 6cms
7. Upper and Lower airway obstruction
8. Patients on beta blockers
9. Patients with known allergy to study drugs |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Objective of this study to assess the effects of dexmedetomidine and fentanyl on the ease of insertion and hemodynamic changes on placement of i-gel |
Objective of this study to assess the effects of dexmedetomidine and fentanyl on the ease of insertion on placement of i-gel and hemodynamic changes on placement of i-gel after 1minute and 3minutes and 5minutes and 10minutes after the placement of i-gel |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
04/08/2025 |
| 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
|
General anaesthesia is a critical component of many surgical procedures, ensuring patient comfort and optimal conditions for surgeons. Among the various tools and drugs used in general anaesthesia, i-gel, a second generation supraglottic airway not only has an easier insertion but has also been reported to cause lesser airway morbidity. This will be a randomized clinical trial conducting to compare the effects of i-gel insertion conditions using dexmedetomidine and fentanyl in patients undergoing surgery under general anaesthesia. A total of 80 patients, ASA i/ii, aged 18-60 years undergoing general anaesthesia for elective surgical procedures, fulfilling the inclusion criteria and willing to give informed written consent will be enrolled. They will be randomly allocated into two groups. Group A (patients will receive 0.5mcg/kg dexmedetomidine) and Group B (patients will receive 1mcg/kg fentanyl). I-gel insertion conditions with both the groups will be assessed and compared. Hemodynamic changes during i-gel insertion using both the groups will be determined and compared. The data will be analysed using SPSS statistics software version 26. Student t-test will be used for comparisons between HR and MAP at each time point and Chi-square test will be used for categorical data. |