Comparison of Neuroprotection by Propofol and Desflurane for POCD Following Subarachnoid Hemorrhage Surgery
NCT ID: NCT02987218
Last Updated: 2016-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2015-07-31
2016-11-30
Brief Summary
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Detailed Description
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Cognition assessed using MOCA (Montreal Cognitive Assessment)test. A preoperative assessment for establishing the patient's baseline performance. Surgery-related factors may affect test performance if performed too early to reduce possibility of confounding factors, we planned to conduct the test for POCD at the time of discharge of the patient after surgery. To compare long term protection provided by anesthetic agent cognitive functions were assessed at one month following surgery.
Cognitive functions will be assessed at following time period A) Preoperatively B) Postoperatively B1- At the time of discharge B2- 1month after discharge following surgery.
Biomarker levels S100B levels were also measured A) Preoperatively B) Intraoperatively - post clipping C) Postoperatively - 1hour after surgery
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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PROPOFOL
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation
Propofol
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation
DESFLURANE
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
Desflurane
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
Interventions
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Propofol
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation
Desflurane
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
Eligibility Criteria
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Inclusion Criteria
2. Age between 18 to 65 yrs.
3. World Federation of neurosurgery grade 1, 2.
4. American society of Anesthesia grade 1, 2 and 3.
Exclusion Criteria
2. Patients with known psychiatric disease.
3. History of drug abuse.
4. Low level of education (illiterate) or multiple failures in school.
5. Patients who are unconscious, intubated or tracheostomised even after two weeks following exposure to anesthesia will also be excluded from the study.
6. Intraoperative complications like massive blood loss, prolonged clipping time(\>20minutes), severe intraoperative brain swelling precluding replacement of bone flap.
7. Patients with infectious diseases and respiratory complications.
8. Multiple surgeries.
18 Years
65 Years
ALL
No
Sponsors
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Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
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Dr Shalvi mahajan
Senior Resident
Principal Investigators
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Shalvi Mahajan, MD
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh
Hemant Bhagat, DM
Role: PRINCIPAL_INVESTIGATOR
Post Graduate Institute of Medical Education and Research, Chandigarh
Locations
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Postgraduate institute of medical education and research
Chandigarh, Chandigarh, India
Countries
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References
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Wong GK, Lam S, Ngai K, Wong A, Mok V, Poon WS; Cognitive Dysfunction after Aneurysmal Subarachnoid Haemorrhage Investigators. Evaluation of cognitive impairment by the Montreal cognitive assessment in patients with aneurysmal subarachnoid haemorrhage: prevalence, risk factors and correlations with 3 month outcomes. J Neurol Neurosurg Psychiatry. 2012 Nov;83(11):1112-7. doi: 10.1136/jnnp-2012-302217. Epub 2012 Jul 31.
Other Identifiers
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INT/IEC/2015/741
Identifier Type: -
Identifier Source: org_study_id