| CTRI Number |
CTRI/2011/09/002013 [Registered on: 19/09/2011] Trial Registered Retrospectively |
| Last Modified On: |
19/09/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
evaluation of hemodynamic and blood gases changes in children undergoing laparoscopic surgeries |
|
Scientific Title of Study
|
laparoscopic versus open surgery- a comparative evaluation of hemodynamic, blood gases and acid-base changes in children undergoing abdominal operations |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
meenakshi verma |
| Designation |
pg student |
| Affiliation |
lady hardinge medical college |
| Address |
department of anesthesia,
lady hardinge medical college,
new delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
drmeenakshilhmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
dr usha saha |
| Designation |
director professor |
| Affiliation |
lady hardinge medical college |
| Address |
department of anesthesia,
lady hardinge medical college,
new delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
usha_shivsaha@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
meenakshi verma |
| Designation |
pg student |
| Affiliation |
lady hardinge medical college |
| Address |
department of anesthesia
lady hardinge medical college,
new delhi
New Delhi
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
drmeenakshilhmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| lady hardinge medical college |
|
|
Primary Sponsor
|
| Name |
lady hardinge medical college |
| Address |
lady hardinge medical college,
shahid bhagat singh marg,
new delhi |
| 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 |
| meenakshi verma |
department of anesthesia |
department of anesthesia,
kalawati saran children hospital,
lady hardinge medical college,
shahid bhagat singh marg,
new delhi
New Delhi
DELHI |
9891494998
drmeenakshilhmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| hospital ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I AND II requiring abdominal surgeries, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
ASA I & II,
for abdominal surgery |
|
| ExclusionCriteria |
| Details |
children with any congenital anomaly,
difficult intubation,
ASA III & IV |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
heart rate- no significant change,
BP- increased after creation of pneumoperitoneum,
pCO2 values increased after creation of pneumoperitoneum and then came back to baseline level 10-15 minutes after desufflation
EtCO2 values were significantly higher in laparoscopic group. |
hemodynamic parameters- baseline and then every 5 minutes till creation of pneumoperitoneum after that every 15 minutes till 1 hour and then every 30 minutes till the end of procedure.
acid- base and blood gases- i)after induction
ii)15 minutes after creation of pneumoperitoneum
iii)post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
i)duration of surgery was similar in both the groups
ii)duration of hospital stay was longer in open surgery group
iii)EtCO2 values were 7-8 mmHg less than PaCO2 values in both the groups at all times
|
EtCO2 values- baseline and then every 5 minutes till creation of pneumoperitoneum after that every 15 minutes till 1 hour and then every 30 minutes till the end of procedure.
blood gases- i)after induction
ii)15 minutes after creation of pneumoperitoneum
iii)post extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study was to evaluate and compare hemodynamic changes, blood gas and acid-base parameters, duration of hospital stay and any complications which occurred. An attempt was also made to correlate PaCO2 to EtCO2 changes. in our study, we have not found any significant change in heart rate. both, systolic and diastolic BP values were higher in laparoscopic group after creation of pneumoperitoneum, PH values were decreased after creation of pneumoperitoneum |