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Clinical Trials/CTRI/2024/10/075436
CTRI/2024/10/075436
Not yet recruiting
Not Applicable

Randomised Comparative Study On Sevoflurane Consumption And Time To Tracheal Extubation By Using Bispectral Index Monitoring Versus End-Tidal Agent Concentration Monitoring In Patients Undergoing Sevoflurane Based General Anaesthesia, At S.M.S Medical College Jaipur

Department of AnaesthesiologySawai Man Singh Medical College And Attached Hospitals Jaipur1 site in 1 country64 target enrollmentStarted: October 21, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Department of AnaesthesiologySawai Man Singh Medical College And Attached Hospitals Jaipur
Enrollment
64
Locations
1
Primary Endpoint
1.To determine and compare the time to tracheal extubation under Sevoflurane based anaesthesia between BIS and ETAC monitoring.

Overview

Brief Summary

Maintaining an optimal depth of anaesthesia during surgery is essential toprevent awareness and to ensure a rapid , smooth recovery. Clinical parameters like Heart rate , BP , increased secretions or movement are subjective and thus not reliable for assessing the depth if anaesthesia .Bispectral index(BIS) is developed from a processedelectroencephalogram and used in anaesthetised patients, has been shown to decrease theincidence of post-operative recall for intra operative awareness when maintained below

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients undergoing elective urology surgery under Sevoflurane based general anaesthesia between 60-120 minutes.
  • ASA grade I & II.Patients with BMI less than 30 kg per meter squared.

Exclusion Criteria

  • 1.Patients with history of long term use of psychoactive and anticonvulsant medications.
  • 2.Patients with psychiatric illness, known or suspected electroencephalographic abnormalities (EEG).
  • 3.Patients with pre existing renal or hepatic diseases.
  • 4.Patients with preexisting pulmonary diseases.
  • 5.Patients with pre existing cardiac diseases.
  • Patients with anticipated difficult airway 7.Patients with dementia and stroke with residual neurological deficits.

Outcomes

Primary Outcomes

1.To determine and compare the time to tracheal extubation under Sevoflurane based anaesthesia between BIS and ETAC monitoring.

Time Frame: From baseline to completion of surgery every 5 minutes

2.To determine and compare the sevoflurane consumption in patients undergoing sevoflurane based general anesthesia between BIS and ETAC monitoring .

Time Frame: From baseline to completion of surgery every 5 minutes

Secondary Outcomes

  • 1.To determine and compare recovery time under Sevoflurane based anaesthesia between BIS and ETAC monitoring .

Investigators

Sponsor
Department of AnaesthesiologySawai Man Singh Medical College And Attached Hospitals Jaipur
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Siddhartha Sharma

Sawai Man Singh Medical College And Attached Hospitals

Study Sites (1)

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