| CTRI Number |
CTRI/2019/06/019768 [Registered on: 19/06/2019] Trial Registered Prospectively |
| Last Modified On: |
18/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two anaesthetic regimens intravenous (propofol-fentanyl) and inhalation (sevoflurane-fentanyl) in intraoperative and postoperative effects in brain tumor surgery |
|
Scientific Title of Study
|
Comparision of two anaesthetic regimens(Propofol-fentanyl)versus(sevoflurane-fentanyl) on perioperative haemodynamics,operating conditions and immediate postoperative outcomes in patients undergoing elective neurosurgical procedures involving brain tumors |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sashmita kumari Padhy |
| Designation |
senior resident (DM)neuroanaesthesia |
| Affiliation |
SCTIMST TRIVANDRUM |
| Address |
Division of neuroanaesthesia,Neurosurgery OT,4th floor
Division of neuroanaesthesia,Neurosurgery OT,4th floor
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7873216296 |
| Fax |
|
| Email |
padhysmi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manikandan S |
| Designation |
proffessor and head of division of neuroanaesthesia |
| Affiliation |
SCTIMST TRIVANDRUM |
| Address |
Srichitra Tirunal institute of medical science and technology,Trivandrum
SCTIMST,Trivandrum
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446334711 |
| Fax |
|
| Email |
kanmanis@sctimst.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sashmita kumari Padhy |
| Designation |
senior resident (DM)neuroanaesthesia |
| Affiliation |
SCTIMST TRIVANDRUM |
| Address |
division of neuroanaesthesia,neurosurgery OT,4th floor
division of neuroanaesthesia,neurosurgery OT,4th floor
Thiruvananthapuram
KERALA
695011
India |
| Phone |
7873216296 |
| Fax |
|
| Email |
padhysmi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Chitra Tirunql Institute For Medical Sciences And Technology, Trivandrum |
|
|
Primary Sponsor
|
| Name |
Dr Sashmita kumari padhy |
| Address |
Senior Resident
Sree Chitra Tirunql Institute For Medical Sciences And Technology, Trivandrum |
| 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 |
| Dr Sashmita Kumari Padhy |
SCTIMST |
Division of neuroanaesthesia,neurosurgery OT,4th floor
Thiruvananthapuram
KERALA |
7873216296
padhysmi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ECR/189/Inst/KL/2013 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G93||Other disorders of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
group 1 patient will get titrated cincentration of sevoflurane end tidal and MAC value titrated to keep BIS 45 to 50 |
group 1 patient will get titrated cincentration of sevoflurane end tidal and MAC value titrated to keep BIS 45 to 50 |
| Intervention |
Group 1 patients will be given titrared sevoflurane to keep BIS value 45 to 50 |
Sevoflurane vaporiser dial concentration titrated according to BIS value between 45-50 and end tidal sevoflurane and MAC value of sevoflurane monitored.recovery profile ,intraop brain relaxtation will be compared with propofol group |
| Comparator Agent |
group 2 patients will get titrated dose of propofol infusion to keep BIS 45 to 50 |
effect site concentration of propofol calculated through TCI pump schneider model,titrated to keep BIS 45 to 50 |
| Intervention |
Group 2 patients will be given titrated dose of propofol infusion to keep BIS value 45 to 50 |
Propofol infusion will be given through target control infusion pump,effect site concentration through schneider model calculated,effect site concentration of propofol will be titrated to maintain BIS value 45 to 50.introp brain relaxttion,recovery profile and haemodynamics compared with group 1 patients |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients undergoing elective neurosurgeries for primary brain tumors of age between 18 to 60 years,of either sex, ASA 1 and 2, GCS 14-15 |
|
| ExclusionCriteria |
| Details |
patients with cardiac disease,uncontrolled hypertension,uncontrolled dibetic,COPD,hepatic and renal dysfunction,age less than 18 years,more than 60 years,GCS less than 13,ASA 3 and 4,recurrent tumors,patient who had surgery related complication like vascular injury,massive bleeding,injury to vital structre requiring postop ventillatory support,obese patient |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Brain relaxtation ,recovery from anaesthesia like time to eye opening,time to obey commands ,time to extubation after discontinuation of anaesthesia,intraoperative haemodynamics,post extubation haemodynamics |
Time taken for eye opening,to obey verbal command ,time for extubation after discontinuation of anaesthesia noted,brain relaxtation assesed by neurosurgeon at time of bone reflection,dural reflection,tumor ressection,dural closure assesesd,haemodynamics preop,preinduction,intubation,pinning,postpinning,skin incision,15 min interval till dural closure,at durl closure,subcutaneous tissue,skin,declamping,preextubation,extubation and immediately after extubation upto 1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| postop side effects pain,PONV,shivering,agitation,convulsion,desaturation.total opoid consumption,total propofol consumption,any bolus dose of propofol and amount,effect site concentration of propofol during induction,intraop period,sevoflurane end tidal concentation and MAC value during intraop period |
intraoperative period upto 24 hours after extubation |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
20/06/2019 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a prospective,randomised double blind single center study .Eligible patients with brain tumor will be administered written informed consent prior to enrollment in study.Patients will be randomised to receive either propofol-fentanyl group or sevoflurane - fentanyl group for maintainence of anaesthesia. Group 1 patients will get sevoflurane for maintainence of anaesthesia.Sevoflurane concentration end tidal value and MAC value titrated to maintain BIS between 45 to 50.Fentanyl infusion 1mcg/kg/hr continued upto starting of closure of subcutaneous tissue in both the groups.Group 2 patients will get propofol infusion for maintainence of anaesthesia.propofol effect site concentration calculated through schneider model TCI pump,effect site concentration titrated to maintain BIS 45 to 50. Anaesthesia discontinued at end of skin closure.Intraoperative brain relaxtation will be assesed by 4 point scale at the time of bone deflection,dural reflection,tumor ressection and dural closure. Haemodynamics will be recorded pre operative period,pre induction ,intubation,post intubation,pinning,post pinning,skin incision,15 minute interval till dural closure,closure of dura,subcutaneous tissue,skin closure,declamping of pin,extubation and immediately after extubation upto 1hour recorded. total fentanyl used during surgery,sevoflurane end tidal concentration,MAC value ,effect site concentration of propofol , any bolus dose of propofol,total propofol consumption,Side effects like nausea,vomitting,shivering,pain (assessed by VAS upto 6 hours of extubation),desaturation,delerium or agitation ,covulsion will be observed and any treatment to be recorded. |