Comparision of two anaesthetic regimens intravenous (propofol-fentanyl) and inhalation (sevoflurane-fentanyl) in intraoperative and postoperative effects in brain tumor surgery

Phase 4

Not yet recruiting

Conditions: Other disorders of brain,

Registration Number: CTRI/2019/06/019768

Lead Sponsor: Dr Sashmita kumari padhy

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): SCTIMST
🇮🇳
Thiruvananthapuram, KERALA, India
SCTIMST
🇮🇳Thiruvananthapuram, KERALA, India
Dr Sashmita Kumari Padhy
Principal investigator
7873216296
padhysmi@gmail.com