| CTRI Number |
CTRI/2024/08/073027 [Registered on: 28/08/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical interventional trial comparing dexmedetomidine versus fentanyl along with propofol for Proseal Laryngeal mask airway insertion.The participants include Adult patients undergoing elective surgeries |
|
Scientific Title of Study
|
Comparison of dexmedetomidine versus fentanyl co-induction with propofol for insertion of proseal laryngeal mask airway in adult patients undergoing elective surgeries - A prospective randomized double blind 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 |
Jeevanragul S |
| Designation |
DNB Anaesthesiology |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Department of anaesthesia, Ot complex,2nd Floor, Kovai Medical Center and Hospital, 99 Avinashi road, Coimbatore. Coimbatore TAMIL NADU 641014 India
Coimbatore
TAMIL NADU
641014
India |
| Phone |
8883133587 |
| Fax |
|
| Email |
jeevanragul75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Amar.N DA, MD, DNB |
| Designation |
Consultant Anaesthesiologist |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Department of anaesthesia, Ot complex,2nd Floor, Kovai Medical Center and Hospital, 99 Avinashi road, Coimbatore. Coimbatore TAMIL NADU 641014 India
Coimbatore
TAMIL NADU
641014
India |
| Phone |
9486369403 |
| Fax |
|
| Email |
amarailanto@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Jeevanragul.S |
| Designation |
DNB resident |
| Affiliation |
Kovai Medical Center and Hospital |
| Address |
Department of anaesthesiology, Ot complex,2nd Floor, Kovai Medical Center and Hospital, 99 Avinashi road, Coimbatore. Coimbatore TAMIL NADU 641014 India
Coimbatore
TAMIL NADU
641014
India |
| Phone |
8883133587 |
| Fax |
|
| Email |
jeevanragul75@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kovai Medical Center and Hospital,99 Avinashi road, Coimbatore-641014 Tamilnadu,India. |
|
|
Primary Sponsor
|
| Name |
Jeevanragul.S |
| Address |
Kovai Medical Center and Hospital, 99 Avinashi road, Coimbatore-641014, Tamilnadu, India. |
| 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 |
| DrJeevanragulS |
Kovai Medical Center and Hospital |
Department of Anaesthesia, Ot complex, 2nd Floor, Kovai Medical Center and Hospital,99 Avinashi road, Coimbatore Coimbatore TAMIL NADU
Coimbatore
TAMIL NADU |
8883133587
jeevanragul75@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kmch Ethics committee Kovai Medical Center and Hospital, No 99, Avinashi road, Coimbatore. |
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 |
Use of drug Dexmedetomidine along with drug Propofol for Proseal laryngeal mask airway insertion |
Study duration: 1 year(September 2024 - September 2025) Dexmedetomidine will be given in a dose of 0.5 mcg/kg intravenously over 10 minutes along with Propofol for Proseal laryngeal mask airway insertion in adult patients undergoing elective surgeries |
| Comparator Agent |
Use of drug Fentanyl along with drug Propofol for Proseal laryngeal mask airway insertion |
Study duration: 1 year(September 2024 - September 2025) Fentanyl will be given in a dose of 1.5 mcg/kg intravenously over 10 minutes along with Propofol for Proseal laryngeal mask airway insertion in adult patients undergoing elective surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2
Patient weight between 40 to 80 kg
Adult patients undergoing elective surgical procedures with general anaesthesia using Proseal laryngeal mask airway |
|
| ExclusionCriteria |
| Details |
Patient refusal
Elective surgical procedures which need muscle relaxant
ASA 3 or more
Hypertensive patients
Patient baseline heart rate less than 60/min
BMI more than 35kg/m2
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare dexmedetomidine against fentanyl along with propofol for optimum insertion of proseal laryngeal mask airway in adult patients undergoing elective surgeries |
Ease of insertion of proseal laryngeal mask airway will be assessed after induction with propofol at 1 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the hemodynamic response(heart rate, Blood pressure, oxygen saturation) during insertion of proseal laryngeal mask airway.
|
Heart rate,Blood pressure & Oxygen saturation will be recorded at baseline,after propofol induction, at 1, 3, 5 & 10 minutes after insertion of Proseal Laryngeal mask airway |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
10/09/2024 |
| 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="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
|
This is a Prospective randomized control study comparing the efficacy of dexmedetomidine against fentanyl along with propofol for the ease of insertion of proseal laryngeal mask airway in adult patients undergoing elective surgeries.The study will be conducted in Kovai Medical Center and Hospital, Coimbatore.After getting informed written consent from the patients ,they will be divided into 2 groups. One group will receive Dexmedetomidine 0.5 mcg/kg along with Propofol and other group will receive Fentanyl 1.5 mcg/kg along with Propofol and Proseal LMA will be inserted. Primary outcome is ease of insertion of Proseal LMA which will be assessed by Muzi et al LMA insertion score. Secondary outcome is to compare the hemodynamic parameters between both groups. |