| CTRI Number |
CTRI/2024/12/077541 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
29/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison between different flow of anesthesia in laparoscopic cholecystectomy |
|
Scientific Title of Study
|
A comparison of low flow anesthesia with gas monitor vs high flow anesthesia during laparoscopic cholecystectomy A Randomized controlled 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 |
Dr Jatin B Patel |
| Designation |
Professor |
| Affiliation |
Sumandeep vidyapeeth deemed to be University |
| Address |
Department of Anesthesia,Dhiraj Hospital,Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Center,Sumandeep Vidyapeeth An institution to be Deemed university,Piparia,Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin B Patel |
| Designation |
Professor |
| Affiliation |
Sumandeep vidyapeeth deemed to be University |
| Address |
Department of Anesthesia,Dhiraj Hospital,Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Center,Sumandeep Vidyapeeth An institution to be Deemed university,Piparia,Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jatin B Patel |
| Designation |
Professor |
| Affiliation |
Sumandeep vidyapeeth deemed to be University |
| Address |
Department of Anesthesia,Dhiraj Hospital,Shrimati Bhikhiben Kanjibhai Shah Medical Institute and Research Center,Sumandeep Vidyapeeth An institution to be Deemed university,Piparia,Waghodia
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sumandeep Vidyapeeth Deemed to be University,Piparia,Waghodia,Vadodara,Gujarat,Pin code-391760,India. |
|
|
Primary Sponsor
|
| Name |
Sumandeep Vidyapeeth Deemed to be University |
| Address |
Shrimati Bhikhiben Kanjibhai Shah Medical Institute And Research Center,Sumandeep Vidyapeeth Deemed to be University,Piparia,Ta-Waghodia,Vadodara,Gujarat,Pincode-391760 |
| Type of Sponsor |
Private 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 Jatin Babubhai Patel |
Dhiraj Hospital,Sumandeep vidyapeeth deemed to be university |
Department of anesthesia,2nd floor Ot complex
,Sumandeep Vidyapeeth deemed to be university,Piparia,Vadodara,Gujarat,391760,India.
Vadodara
GUJARAT |
9879368363
dr_jatinpatel@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional 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 |
| Comparator Agent |
High flow anesthesia |
In high flow anesthesia uses fresh gas flow(FGF) is close to the patients minute ventilation, 3-6 liters per minute(L/MIn) for an adults. Sevoflurane will be used as inhalation agent for high flow anesthesia.In this group we will keep FGF of 6 L/min-O2/N2O (50/50 %) with 2% sevoflurane till end of the surgery. |
| Intervention |
Low flow anesthesia with Gas Monitor |
Low flow anesthesia is defined to be an inhalation anesthetic technique via a
rebreathing system in which the rebreathing fraction at least amounts to 50 % (i.e. 50%
of the exhaled gas volume is led back to the patient after carbon dioxide absorption in the next inspiration.Gas monitor helps During low flow anesthesia in safe conduct of anesthesia and
continuous monitoring of the anesthetic agent concentration. Sevoflurane will be used as inhalation agent in Low flow anesthesia.In this group we will keep FGF of 1 L/min-O2/N2O (50/50 %) with 2% sevoflurane till end of the surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign inform consent.
Patients undergoing elective laparoscopic cholecystectomy surgeries under general anesthesia aged between 20 and 50 years.
Patients belonging to American Society of Anaesthesiologist physical status !and II
|
|
| ExclusionCriteria |
| Details |
Patients refused.
All below 20 and above 50 years.
Patients with ASA III or more.
Patients with known allergy, sensitivity or any other form of reactionn to any drug.
Patients with systemic comorbidities.
Posted for open cholecystectomy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the amount of inhalation agent sevoflurane during laparoscopic surgery with or without gas monitor.
To observe the hemodynamic parameter,oxygen saturation and end tidal CO2,N2O |
0,3,5,10,15,30,45,60,75,90,105,120 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe side effect or complication durinng peri operative periods. |
0,3,5,10,15,30,45,60,75,90,105,120 minutes |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
16/12/2024 |
| 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
|
Low flow anesthesia is defined to be an inhalation anesthetic technique via a
rebreathing system in which the rebreathing fraction at least amounts to 50 % (i.e. 50%
of the exhaled gas volume is led back to the patient after carbon dioxide absorption in the next inspiration[3].During low flow anesthesia , for the safe conduct of anesthesia ,
continuous monitoring of the anesthetic agent concentration should consider
mandatory.
The main advantages of low flow techniques are economy, climatization of the inspired gases, and reduced atmospheric pollution[3].Low flow anesthesia with one of
the third generation halogenated anesthetic, desflurane or sevoflurane has shown cost
effective and is becoming more and more commonly adopted. Gas monitor shows anesthetic gas concentration and MAC values of inhalation gases which enhances patient’s safety during anesthesia periods.
|