| CTRI Number |
CTRI/2020/02/023509 [Registered on: 21/02/2020] Trial Registered Prospectively |
| Last Modified On: |
21/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to know the changes in oxygenation, blood presure and heart rate when low and high flow of anaesthetic gases are used in laparoscopic appendix operation. |
|
Scientific Title of Study
|
A comparative clinical study of effect of low flow and high flow anaesthesia on the intraoperative respiratory and hemodynamic changes during elective laparoscopic appendicectomies |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jananee V B |
| Designation |
Post graduate |
| Affiliation |
Kempegowda institute of medical science and research hospital |
| Address |
Department of anesthesia , kempegowda institute of medical science , Vv puram ,KR road, Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
7708535766 |
| Fax |
|
| Email |
v.bjananee@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhava Reddy R |
| Designation |
Professor |
| Affiliation |
KIMS |
| Address |
Department of anesthesia, kempegowda institute of medical science and research hospital, V V puram, KR road Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
9379094790 |
| Fax |
|
| Email |
madhavareddy.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jananee V B |
| Designation |
Post graduate |
| Affiliation |
KIMS |
| Address |
Department of anesthesia, kempegowda institute of medical science, V V puram, KR road, Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
7708535766 |
| Fax |
|
| Email |
v.bjananee@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Jananee V B
post graduate in kempegowda institute of medical science vv puram , KR road bangalore |
|
|
Primary Sponsor
|
| Name |
Jananee V B |
| Address |
Post graduate , department of anesthesia , kempegowda institute of medical science, V V puram K R road, Bangalore |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Jananee V B |
Kempegowda institute of medical science |
Department of anesthesia,4t floor, A block, Kempegowda institute of medical science and research hospital vv puram Bangalore
Bangalore
KARNATAKA |
7708535766
v.bjananee@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
low flow and high flow anesthesia in laparoscopic appendicectomy |
comparing hemodynamic changes and respiratory parameters intraoperatively between low flow and high flow anesthesia in elective laparoscopic appendicectomy. Fresh gas flow of 1litre 50% of nitrous and 50% oxygen in low flow group and 6litre in high flow group. From time intubation to the time of extubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical satus 1 and 2 of either sex
Mallampatti class I and II
Scheduled for elective laparoscopic appendicectomy |
|
| ExclusionCriteria |
| Details |
ASA Physical status >2
Emergency laparoscopic appendicectomy
Mallampatti class III, IV
Morbid obesity
smokers, asthmatic, any lung pathology
COPD, Ischemic heart disease
Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing the effects of Low flow and High flow anesthesia on the intraoperative hemodynamic and respiratory changes in elective laparoscopic appendicectomy |
Till patient is shifted from operation theatre to post operative recovery unit |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
21/02/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the effects of low flow anesthesia and high flow anesthesia on the intraoperative hemodynamic and respiratory changes in patients undergoing elective laparoscopic appendicectomy. To prove low flow anesthesia is beneficial and cost effective |