| CTRI Number |
CTRI/2018/02/011746 [Registered on: 07/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
19/11/2019 |
| 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 comparing general anesthesia and spinal anesthesia in respect to variation in heart rate and blood pressure due to gas insufflation of abdomen in elective laparoscopic appendix operations |
|
Scientific Title of Study
|
A comparitive clinical study of hemodynamic response due to pneumoperitoneum between general and spinal anesthesia for elective laparoscopic appendicectomy |
| Trial Acronym |
GSLA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komala B |
| Designation |
Post graduate |
| Affiliation |
KIMS |
| Address |
Post graduate
Department of Anesthesiology
KIMS Hospital
BANGLORE
KIMS resident qurters
room no-404
KIMS hospital
BANGLORE
Bangalore
KARNATAKA
560004
India |
| Phone |
7204856186 |
| Fax |
|
| Email |
komalaharini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhava Reddy R |
| Designation |
Professor |
| Affiliation |
KIMS |
| Address |
Professor
DepartmentT of Anesthesiology
KIMS Hospital
Banglore
Bangalore
KARNATAKA
560004
India |
| Phone |
7204856186 |
| Fax |
|
| Email |
madhavareddy.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Komala B |
| Designation |
Post graduate |
| Affiliation |
Kempegowda Institute of Medical Sciences |
| Address |
Post graduate
Department of anesthesiology
Kempegowda Institute of Medical Sciences
Banglore
Bangalore
KARNATAKA
560004
India |
| Phone |
7204856186 |
| Fax |
|
| Email |
komalaharini@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Komala B |
| Address |
Post graduate
Department of anesthesiology
Kempegowda Institute of Medical Sciences
BANGALORE |
| 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 |
| Komala B |
Kempegowda Institute of Medical Sciences Bangalore |
Post graduate
Department of Anesthesiology
Kempegowda Institute of Medical Sciences
Banglore
Bangalore
KARNATAKA |
7204856186
7204856186
komalaharini@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KIMS institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA 1 and ASA 2, (1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
general anesthesia for elective laparoscopic appendicectomy |
comparing hemodynamic changes due to pneumoperitoneum between spinal anesthesia and general anesthesia for elective laparoscopic appendicectomy |
| Intervention |
spinal anesthesia |
general anesthesia |
| Comparator Agent |
spinal anesthesia for elective laparoscopic appendicectomy |
comparing hemodynamic changes due to pneumoperitoneum between spinal anesthesia and general anesthesia for elective laparoscopic appendicectomy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA Physical status 1 and 2 of either sex
2.mallampati class 1 and 2
3.scheduled for elective laparoscopic appendicectomy |
|
| ExclusionCriteria |
| Details |
1.Emergency laparoscopic appendicectomy
2.appendicular mass/abscess
3.any contraindications for spinal anesthesia
4.weight>70kg |
|
|
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 hemodynamic response between spinal and general anesthesia for 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="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/11/2017 |
| Date of Study Completion (India) |
23/08/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the hemodynamic variations due to pneumoperitoneum between general anesthesia and spinal anesthesia in patients undergoing elective laparoscopic appendicectomy. |