| CTRI Number |
CTRI/2025/04/084977 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two drugs d during insertion of a device |
|
Scientific Title of Study
|
A clinical comparative study of etomidate and propofol plus ketamine as an induction agent on quality of proseal laryngeal mask airway insertion and hemodynamic stability in patients undergoing laparoscopic cholecystectomy |
| 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 Yogesh Kumar Manik |
| Designation |
Professor |
| Affiliation |
LALA LAJPAT RAI MEDICAL COLLEGE,MEERUT ,UP |
| Address |
Department of anaesthesia, LLRM MEDICAL COLLEGE, MEERUT, UP
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
anaesthesiadeptt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yogesh Kumar Manik |
| Designation |
Professor |
| Affiliation |
LALA LAJPAT RAI MEDICAL COLLEGE,MEERUT ,UP |
| Address |
Department of anaesthesia, LLRM MEDICAL COLLEGE, MEERUT, UP
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9634857368 |
| Fax |
|
| Email |
anaesthesiadeptt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyotiraj sahoo |
| Designation |
Junior resident |
| Affiliation |
Lala Lajpat rai medical college, Meerut ,UP |
| Address |
Department of anaesthesia , LLRM MEDICAL COLLEGE, Meerut, UP
Meerut
UTTAR PRADESH
250004
India |
| Phone |
9560201792 |
| Fax |
|
| Email |
sahoo.jyotiraj01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia LLRM medical college meerut 250004 |
|
|
Primary Sponsor
|
| Name |
Lala Lajpat rai medical college,Meerut, UP |
| Address |
Department of anaesthesia,LLRM MEDICAL COLLEGE, MEERUT,UP |
| 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 Yogesh Kumar Manik |
LLRM MEDICAL COLLEGE, MEERUT ,UP |
Department of Anaesthesia, LLRM MEDICAL COLLEGE, MEERUT,UP
Meerut
UTTAR PRADESH |
9634857368
anaesthesiadeptt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Comparison of drugs in inserting Proseal laryngeal mask airway insertion |
Two groups will be made
Group A - will be given etomidate 0.3mg/kg without muscle relaxant before insertion of proseal LMA
Group B - will be given combination of propofol 1.5mg/kg and ketamine 0.5mg/kg without muscle relaxant before insertion of proseal LMA
Comparison of both the groups to see ease of insertion of the proseal LMA and hemodynamic stability in patient undergoing laparoscopic cholecystectomy. |
| Comparator Agent |
Etomidate
|
Inj. etomidate 0.3mg/kg without muscle relaxant given before insertion of proseal LMA to observe ease of insertion and hemodynamic stability
|
| Comparator Agent |
Inj. Propofol plus ketamine |
Inj. propofol 1.5mg/kg and ketamine 0.5mg/kg without muscle relaxant before insertion of proseal LMA to see ease of insertion of proseal LMA and hemodynamic stability |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Age 18 to 65 years of either sex
Patient undergoing laparoscopic cholecystectomy
Patient with informed consent
MPG I and II |
|
| ExclusionCriteria |
| Details |
Patient refusal
Patient with history gastroesopheal disease
Patient with cardiac disease, lung disease,alcholism,morbid obesity,pregnancy,any abnormality of oral cavity or pharynx or patient prone for pulmonary complications like COPD, Pneumonia
ASA III,IV,V
Patient undergoing emergency surgery
Patients with uncontrolled hypertension,uncontrolled diabetes,previous history of stroke
Cervical spine fracture or instability
Morbid obese patient |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To see the effectiveness of insertion and establishment of airway with Proseal larynseal mask airway on induction with etomidate and propofol plus ketamine in patient undergoing laparoscopic cholecystectomy.
Comparison of effectiveness of the induction agents for adequate relaxation for inserting PLMA
Time for successful insertion |
1 minutes, 3 minutes 5 minutes 15 minutes 30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Oropharyngeal leak pressure,sore throat
Ease and required attempts for proseal laryngeal mask airway insertion.
Quality of airway with controlled ventilation during maintenance of anaesthesia.
Complications
Hemodynamic stability of induction agents
|
1min, 3min, 5min, 15min, 30min |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/04/2025 |
| 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="2"
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
|
To see effectiveness of insertion and esatblishment of the airway with Proseal laryngeal mask airway on induction with etomidate and propofol plus ketamine in patient undergoing laparoscopic cholecystectomy. Also to see the effectiveness of the induction agents for adequate relaxation for inserting proseal LMA in the absence of any muscle relaxant before inserting proseal LMA |