| CTRI Number |
CTRI/2020/07/026691 [Registered on: 20/07/2020] Trial Registered Prospectively |
| Last Modified On: |
17/07/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of effect of Desflurane and Propofol for Maintenance Anaesthesia on the basis of Arterial CO2 and End tidal CO2 Gradient in laparoscopic donor Nephrectomy patients |
|
Scientific Title of Study
|
To study the effect of desflurane and propofol for maintenance anaesthesia on arterial CO2 and end tidal CO2 gradient in laparoscopic donor nephrectomy patients
A randomised prospective comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aruna Bharti |
| Designation |
Additional Professor,Dept. of Anaesthesiology |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SGPGIMS, Lucknow.
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
|
| Fax |
|
| Email |
cardarone@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Bharti |
| Designation |
Additional Professor,Dept. of Anaesthesiology |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SGPGIMS, Lucknow.
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
|
| Fax |
|
| Email |
cardarone@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Imran |
| Designation |
Junior Resident,Dept. of Anaesthesiology |
| Affiliation |
Sanjay Gandhi Post Graduate Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,
SGPGIMS, Lucknow.
Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, UP 226014
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
|
| Fax |
|
| Email |
doc009imran@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Aruna Bharti |
| Address |
Dept. of Anaesthesiology SGPGIMS lucknow 226014 |
| 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 |
| DrAruna Bharti |
SGPGIMS lucknow |
Urology OT ,OT complex, E- block, SGPGIMS , Lucknow, UP 226014
Lucknow
UTTAR PRADESH |
8004904626
cardarone@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z524||Kidney donor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Desflurane |
Desflurane in an
end-tidal concentration of 2-6 vol% |
| Comparator Agent |
Propofol |
Continuous infusion of propofol
with a dosage of 50-500 micrograms/kg/min |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All ASA grade I and II patients of all age groups posted for laparoscopic donor nephrectomy patients |
|
| ExclusionCriteria |
| Details |
Lack of patient’s consent
Patients posted for open donor nephrectomy
If laparoscopic converted to open (due to any reason) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of desflurane and propofol for maintenance anaesthesia on arterial CO2 and end tidal CO2 gradient in laparoscopic donor nephrectomy patients |
Arterial blood gas at just after induction of anaesthesia ,after 60 min of insufflation, after 120 min of insufflation and just after desufflation of pneumoperitoneum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
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 1 |
|
Date of First Enrollment (India)
|
22/07/2020 |
| 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
|
1-Gehring H, Kuhmann K, Klotz KF, et al. Effects of propofol vs isoflurane on respiratory gas exchange during laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 1998;42(2):189-194. doi:10.1111/j.1399-6576.1998.tb05107.x
2-Husaini J, Choy YC. End-tidal to arterial carbon dioxide partial pressure difference during craniotomy in anaesthetised patients. Med J Malaysia. 2008;63(5):384-387. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
There have been different of arterial to end-tidal CO2 gradient (PaCO2-ETCO2) during various laparoscopic and non laparoscopic surgeries. Laparoscopic procedures, where pneumoperitoneum is introduced using CO2, respiratory function and lung gas exchange are affected. Previous studies on laparoscopic procedures have shown differing results concerning pulmonary gas exchange. Our aim is to study the effects of propofol on lung gas exchange as compared with those of desflurane in patients undergoing elective laparoscopic donor nephrectomy so we are using capnometry and an intravascular blood gas analysis to monitor this gradient in 70 laparoscopic donor nephrectomy patients.Patients who met the inclusion criteria during the pre-anaesthetic check up will be randomly assigned into two equal groups of 35 each with the help of a computer generated table of random numbers and we would compare the values obtained from capnogram with those obtained from a standard arterial blood gas analyser at four time points. |