| CTRI Number |
CTRI/2025/04/084801 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
TO KNOW THE CONSUMPTION OF ANAESTHETIC AGENT BY USING TECHNIQUE CALLED LOW FLOW ANAESTHESIA DURING GALLBLADDER REMOVAL SURGERIES TO MAKE MORE ECONOMICAL |
|
Scientific Title of Study
|
EFFECT OF MINIMAL FLOW
ANAESTHESIA ON DESFLURANE
CONSUMPTION IN PATIENTS
UNDERGOING ELECTIVE 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 NARESHA G N |
| Designation |
POST GRADUATE |
| Affiliation |
SHIVAMOGGA INSTITUTE OF MEDICAL SCIENCES SHIMOGA |
| Address |
Department of Anaesthesiology Major OT complex, 3rd floor McGann district
teaching hospital, SIMS Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9972639656 |
| Fax |
|
| Email |
drnareshgn@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ASHWINI S |
| Designation |
ASSOCIATE PROFFESSOR |
| Affiliation |
SHIVAMOGGA INSTITUTE OF MEDICAL SCIENCES SHIMOGA |
| Address |
Department of Anaesthesiology Major OT complex, 3rd floor McGann district
teaching hospital, SIMS Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9980812398 |
| Fax |
|
| Email |
ashwini.satrasala@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NARESHA G N |
| Designation |
POST GRADUATE |
| Affiliation |
SHIVAMOGGA INSTITUTE OF MEDICAL SCIENCES SHIMOGA |
| Address |
Department of Anaesthesiology Major OT complex, 3rd floor McGann district
teaching hospital, SIMS Shimoga
Shimoga
KARNATAKA
577201
India |
| Phone |
9972639656 |
| Fax |
|
| Email |
drnareshgn@gmail.com |
|
|
Source of Monetary or Material Support
|
| MC GANN DISTRICT TEACHING HOSPITAL, SAGAR ROAD SHIMOGA KARNATAKA 577201 |
|
|
Primary Sponsor
|
| Name |
DR NARESHA G N |
| Address |
Department of Anaesthesiology Major OT complex, 3rd floor McGann district
teaching hospital, SIMS Shimoga |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR NARESHA G N |
DEPARTMENT OF ANAESTHESIOLOGY SIMS SHIMOGA SAGAR ROAD SHIMOGA KARNATAKA 577201 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR NARESHA G N |
GOVT MC GANN DISTRICT TEACHING HOSPITAL |
Department of Anaesthesiology Major
OT complex, 3rd floor McGann
district teaching hospital, SIMS
Shimoga
Shimoga
KARNATAKA
Shimoga
KARNATAKA |
09972639656
drnareshgn@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC SIMS |
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: K819||Cholecystitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DESFLURANE AT FRESH GAS FLOW OF ONE LITER |
WE USE LOW FLOW ANAESTHESIA DURING WITH VARRYING FLOWS OF ONE LITER IN ONE GROUP |
| Intervention |
DESFLURANE AT HALF LITER OF FRESH GAS FLOW |
WE MAKE FRESH GAS FLOW AT HALG LITER DURING GENERAL ANAESTHESIA AND WE WILL CALCULATER AND COMPARE CONSUPTION OF SAME DURING EACH FLOWS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18-65yrs of both sex
2. ASA I, II patients |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
consumption of desflurane by using minimal flow
anaesthesia |
AT END OF EACH SURGERY |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| time to achieve equilibrium from starting of inhalational agent |
|
| TO CALCULATE TIME TO ACHEIVE EQUILIBIUM FROM STARTING OF INHALATIONAL ANESTHESIA |
AT STATING OF SURGERY TO EQUILIUM ACHEIVED STATE |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Desflurane, recognized as the least soluble inhalation
anesthetic, has the lowest blood-gas partition coefficient of
0.42, facilitating rapid adjustments in alveolar concentration. Its low tissue-gas partition coefficient supports quicker
elimination and faster recovery from anesthesia
(2). Additionally, desflurane exhibits superior stability in soda
lime and is less prone to liver biodegradation compared to
other anesthetic agents
. So using lowflow and minimal flow
Anaesthesia with desflurane will be economical and
advantageous than other inhalational agents. |