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Ketofol or Propofol, agent maintaining better haemodynamics in patients undergoing trans-sphenoidal pituitary surgery under total intravenous anaesthesia.

Active, not recruiting
Conditions
Benign neoplasm of other specifiedparts of central nervous system, (2) ICD-10 Condition: G938||Other specified disorders of brain,
Registration Number
CTRI/2022/01/039533
Lead Sponsor
AIIMS
Brief Summary

Although there have been many studies on role of various intravenous anaesthetic agents on maintenance of intraoperative haemodynamics in neurosurgical patients but there has not been many studies comparing their role on maintenance of cerebral oxygenation. So, we plan to conduct this study to compare the effects of two anaesthetic regimen on cerebral oxygenation in patients undergoing TNTS pituitary surgery. In TNTS pituitary surgery the surgical approach is via transnasal and transsphenoidroute. This avoids open craniotomy with the advantage ofavoidance of major handling of brain tissue (like retractor applications) and intracranial vessels, thereby minimizing the effects of surgical factors on cerebral oxygenation. We hypothesize that use of ketofol as induction & maintenance agent will lead to better cerebral oxygenation compared to Propofol alone.

Detailed Description

Not available

Recruitment & Eligibility

Status
Closed to Recruitment of Participants
Sex
All
Target Recruitment
50
Inclusion Criteria

ASA 1, 2 Planned for elective endoscopic TNTS Pituitary Surgery.

Exclusion Criteria

Consent not given Patients with history of previous pituitary surgery Patients with psychiatric disorder History of drug abuse Poorly controlled hypertension Ischaemic heart disease, valvular heart disease History of lung diseases-COPD, Asthma History of Renal diseases History of liver diseases Pituitary apoplexy Morbidly obese ( BMI >40) Pregnant patients History of allergy to any of the planned anaesthetic medications of the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To compare effects of ketofol versus propofol on cerebral oxygenation (rSO2) in patients undergoing TNTS Pituitary surgeryBaseline then Every 30min interval
Secondary Outcome Measures
NameTimeMethod
To compare between both drugs intraoperative haemodynamic parameters ( HR, MAP), intraoperative requirements of propofol and opioids, postoperative emergenceBaseline & every 30min

Trial Locations

Locations (1)

AIIMS, New Delhi

🇮🇳

Delhi, DELHI, India

AIIMS, New Delhi
🇮🇳Delhi, DELHI, India
Dr Sudeshna Padhi
Principal investigator
9674858350
drsud456@gmail.com

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