| CTRI Number |
CTRI/2023/07/055820 [Registered on: 28/07/2023] Trial Registered Prospectively |
| Last Modified On: |
27/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [supraglottic airway device] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of I-gel airway vs SLIPA 2G airway in paediatric paitents undergoing general anaesthesia with caudal epidural anaesthesia |
|
Scientific Title of Study
|
Comparison of I-gel airway vs SLIPA 2G airway in paediatric paitents undergoing general anaesthesia with caudal epidural anaesthesia- one year randomised 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 |
Yashashvi Chouhan |
| Designation |
post graduate student |
| Affiliation |
jn medical college , kle university ,belgaum (karnataka) |
| Address |
Department of Anaesthesia
Jawaharlal nehru medical college
kle university
Belgaum
Karnataka
JN medical college
kle university
nehru nagar
belgaum
karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8554845030 |
| Fax |
|
| Email |
yashashvichouhan7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Manjunath C. Patil |
| Designation |
professor |
| Affiliation |
jn medical college kle university nehru nagar, belgavi (karnataka) |
| Address |
department of anaesthesiology jn medical college kle university
nehru nagar
belgavi
karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9743110637 |
| Fax |
|
| Email |
mcpatil52@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
YASHASHVI CHOUHAN |
| Designation |
post graduate student, DEPARTMENT OF ANAESTHESIA , JNMC, KLE UNIVERSITY, BELGAUM , KARNATAKA |
| Affiliation |
JN medical college , kle university ,belgaum (karnataka) |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY JAWAHARLAL NEHRU MEDICAL COLLEGE NEHRU NAGAR
BELGAUM
Belgaum
KARNATAKA
590010
India |
| Phone |
8554845030 |
| Fax |
|
| Email |
yashashvichouhan7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kle Prbhakar Kore hospital Jawaharlal Nehru medical college Belgaum Karnataka |
|
|
Primary Sponsor
|
| Name |
yashashvi chouhan |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
JAWAHARLAL NEHRU MEDICAL COLLEGE
kle university
nehru nagar
belgaum
karnataka |
| Type of Sponsor |
Other [] |
|
|
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 |
| YASHASHVI CHOUHAN |
KLE Dr Prabhakar Kore hospital belgaum |
DEPARTMENT OF ANAESTHESIOLOGY
JAWAHARLAL NEHRU MEDICAL COLLEGE second floor dr prabhakar kore hospital belgaum karnataka
KLE PRABHAKAR KORE HOSPITAL
NEHRU NAGAR
BELGAUM
KARNATAKA
Belgaum
KARNATAKA |
8554845030
yashashvichouhan7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| jnmc institutional ethics committee , jawarharlal nehru medical college, nehru nagar, belgavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I GEL
|
Children will be premedicated with Inj. glycopyrrolate 0.004mg/kg body weight and Inj. ketamine 1.5mg/kg body weight iv to overcome parental separation anxiety and patient will be shifted to operation theatre, standard monitors will be attached which include ECG, SpO2 and NIBP cuff.
The patient will be divided into two groups-
Group A - The I-gel airway
patient will be pre oxygenated for 3 minutes with paediatric closed circuit using appropriate flow with head resting on a head ring. Patient induced with Inj midazolam 0.05 mg/kg body weight and Fentanyl 2 mcg/kg body weight iv, isoflurane in incremental doses. After achieving adequate depth of anaesthesia, airway of patients in group A will be secured with I-gel. Both devices will be fixed by taping the tube over the chin. No muscle relaxants will be given. Patients will be maintained on spontaneous breathing with assisted ventilation to maintain normocapnia. The I-gel airway will be removed after the surgery is completed.
|
| Comparator Agent |
SLIPA |
Children will be premedicated with Inj. glycopyrrolate 0.004mg/kg body weight and Inj. ketamine 1.5mg/kg body weight iv to overcome parental separation anxiety and patient will be shifted to operation theatre, standard monitors will be attached which include ECG, SpO2 and NIBP cuff.
The patient will be divided into two groups-
Group B - The SLIPA-2G
In both groups patient will be pre oxygenated for 3 minutes with paediatric closed circuit using appropriate flow with head resting on a head ring. Patient induced with Inj midazolam 0.05 mg/kg body weight and Fentanyl 2 mcg/kg body weight iv, isoflurane in incremental doses. After achieving adequate depth of anaesthesia, airway of patients in group B with SLIPA-2G airway of appropriate sizes. Both devices will be fixed by taping the tube over the chin. No muscle relaxants will be given. Patients will be maintained on spontaneous breathing with assisted ventilation to maintain normocapnia. The SLIPA 2G airway will be removed after the surgery is completed.
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA physical status I and II.
2 Age between 1 to 12 years.
3 Patients undergoing elective surgeries like hernia repair, hypospdiasis repair,
Circumcision and brief procedures like cystoscopy under general anesthesia with caudal epidural anaesthesia.
4 Patients giving consent
|
|
| ExclusionCriteria |
| Details |
1 operation time expected >4 hours
2 risk of aspiration,
3 known difficult airway
4 congenital malformations involving respiratory tract
5 cervical spine disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare ease of insertion and oropharyngeal seal pressure in two second generation supraglottic airway devices, I-gel and SLIPA-2G |
0MIN, 1MIN,2MIN,3MIN,4MIN,5MIN |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess pharyngolaryngeal morbidity as hoarseness of voice in post anaesthesia care unit. |
0MIN,1MIN,2MIN,3MIN,4MIN,5MIN |
|
|
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)
|
13/08/2023 |
| 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
|
PLANNING TO PUBLISH AFTER COMPLETION OF STUDY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Supraglottic airway devices are commonly used in general anaesthesia as a less invasive alternative to endotracheal intubation. Use of supraglottic airways have many advantages over endotracheal intubation like more heamodynamic stability, less incidence of post operative sore throat, cough and hoarseness of voice. This study compares the two second generation supraglottic airway devices in peadiatric patient undergoing general anaesthesia with caudal epidural anaesthesia. |