| CTRI Number |
CTRI/2024/03/064517 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of I GEL PROSEAL and BASKA MASK on the basis of efficacy in patient undergoing laproscopic cholecystectomy under general anaesthesia |
|
Scientific Title of Study
|
Comparing The Efficacy OF I-GEL, PROSEAL LMA and BASKA MASK with respect to airway dynamics in patients undergoing laproscopic cholecystectomy under General Anaesthesia. A Randomised Controlled 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 |
DR Fateh Singh Bhati |
| Designation |
Senior Professor |
| Affiliation |
DR. S.N. MEDICALCOLLEGE |
| Address |
DR. S.N. MEDICAL COLLEGE department of anaesthesiology, sector-D, shastri nagar, jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9414127176 |
| Fax |
|
| Email |
fatehbhati68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Resham Singhal |
| Designation |
PG STUDENT |
| Affiliation |
DR. S.N. MEDICAL COLLEGE |
| Address |
DR. S.N. MEDICAL COLLEGE, department of anaesthesia, SECTOR D, SHASTRI NAGAR, JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9649989434 |
| Fax |
|
| Email |
reshamssinghal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Resham Singhal |
| Designation |
PG STUDENT |
| Affiliation |
DR. S.N. MEDICAL COLLEGE |
| Address |
DR. S.N. MEDICAL COLLEGE, department of anaesthesia, SECTOR D, SHASTRI NAGAR, JODHPUR
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9649989434 |
| Fax |
|
| Email |
reshamssinghal@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. S.N. Medical College department of anaesthesia, sector-D, shastri nagar, jodhpur |
|
|
Primary Sponsor
|
| Name |
DR SN MEDICAL COLLEGE |
| Address |
RESIDENCY ROAD, SECTOR-D, SHASTRI NAGAR, JODHPUR, RAJASTHAN 342003 |
| Type of Sponsor |
Government 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 RESHAM SINGHAL |
MDM HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY, MDM HOSPITAL MAIN OT, SECTOR-H, SHASTRI NAGAR, JODHPUR, RAJASTHAN, 342003
Jodhpur
RAJASTHAN |
9649989434
reshamssinghal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR SNMC INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I- gel and Baska mask |
there are three groups group A airway secured with proseal LMA, group B airway secured with I- gel, group C airway secured with Baska mask they are compared with respect to airway dynamics |
| Comparator Agent |
proseal LMA |
in this study, i- gel,, proseal and baska mask are compared with respect to airway dynamics in patient undergoing elective laproscopic cholecystectomy general anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
the patients with age group 20 to 65 years with BMI between 18.5 to 29.9kg/m2 belonging to ASA grade I and II with mallampati class either I or II undergoing elective laproscopic cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
patient with anticipated difficult intubation with mouth opening less than 3 cm and thyromental distance less than 6.5cm
patient who are pregnant confirmed by urine pregnancy test
patient had history of gastric regurgitation had taken treatment in past or on treatment
patient having emergency surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in dynamic compliance at different time intervals using I-GEL, proseal, Baska mask in patient undergoing elective laproscopic cholecystectomy under general anaesthesia |
at the time of insertion of device, after 5 mins of insertion of device, at time of pneumoperitoneum, 30 mins after pneumoperitoneum, 5 mins after removal of pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare changes in oropharyngeal leak pressure |
at the insertion of device, after 5 mins of insertion of device, at pneumoperitoneum, 30 mins after pneumoperitoneum, at 5 min afterr release of pneumoperitoneum |
| to compare insertion time |
time between picking a device and obtaining a proper airway |
| number of attempts |
maximum 3 attempts allowed |
| hemodynamic parameters |
before insertion of device. |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
29/03/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
laproscopic resection of gall bladder has become a standard technique for cholecystectomy due to its less invasive nature. tracheal intubation, though considered as ideal mode of ventilation, has various disadvantages such as increased sympathetic response during tracheal intubation, pneumoperitoneum and extubation. trends have nowadays progressed from the use of endotracheal tube to supraglottic airway devices because of quick placement in the airway, decreased airway manipulation and stable hemodynamics, decreased requirement of neuromuscular blockade, along with lower incidence of postoperative complications such as sore throat, dysphagia and dysphonia. |