Comparison of Neuroprotection by Propofol and Desflurane for POCD Following Subarachnoid Hemorrhage Surgery
Primary Purpose
Postoperative Cognitive Function
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Propofol
Desflurane
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Cognitive Function focused on measuring POCD, subarachnoid hemorrhage, Propofol, Desflurane
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled for aneurysmal SAH surgery with clinical and radiological evidence of cerebral aneurysm.
- Age between 18 to 65 yrs.
- World Federation of neurosurgery grade 1, 2.
- American society of Anesthesia grade 1, 2 and 3.
Exclusion Criteria:
- Co-morbidities other than hypertension and diabetes mellitus like cardiovascular disease and respiratory impairment.
- Patients with known psychiatric disease.
- History of drug abuse.
- Low level of education (illiterate) or multiple failures in school.
- Patients who are unconscious, intubated or tracheostomised even after two weeks following exposure to anesthesia will also be excluded from the study.
- Intraoperative complications like massive blood loss, prolonged clipping time(>20minutes), severe intraoperative brain swelling precluding replacement of bone flap.
- Patients with infectious diseases and respiratory complications.
- Multiple surgeries.
Sites / Locations
- Postgraduate institute of medical education and research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PROPOFOL
DESFLURANE
Arm Description
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
Outcomes
Primary Outcome Measures
Assessment of cognitive function at one month following surgery.
Montreal Cognitive Assessment scale is used
Secondary Outcome Measures
Assessment of cognitive function preoperatively Assessment of cognitive function at discharge. Comparison of biomarker of cognitive dysfunction
Montreal Cognitive Assessment scale used
Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital
Montreal Cognitive Assessment scale used
Comparison of biomarker (S-100B) levels
Blood sample for S100B levels used
Full Information
NCT ID
NCT02987218
First Posted
November 13, 2016
Last Updated
December 6, 2016
Sponsor
Postgraduate Institute of Medical Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT02987218
Brief Title
Comparison of Neuroprotection by Propofol and Desflurane for POCD Following Subarachnoid Hemorrhage Surgery
Official Title
Comparison Of Pharmacological Neuroprotection Provided By PROPOFOL VERSUS DESFLURANE For Long Term Postoperative Cognitive Dysfunction In Patients Undergoing Surgery For Aneurysmal Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aneurysmal subarachnoid hemorrhage (aSAH) is characterized by the rupture of an intracranial aneurysm and accumulation of blood in the subarachnoid space with 30 to 40% mortality rate. Amongst the survivors 40-50% suffers disability due to cognitive decline.Trends towards early surgery offers challenge to anesthesiologist to provide optimum brain relaxation and simultaneously maintaining stable hemodynamics. Anesthetic agents are administered to conduct smooth neurosurgical procedure. These agents may affect patient's cognitive function postoperatively.Currently most common anesthetic agents used are either intravenous hypnotic agents (propofol) or volatile inhalational agents (isoflurane/sevoflurane/desflurane). Provision of neuroprotection with propofol and volatile inhalational agents has been studied by various authors.Not many studies have been performed in patients undergoing aneurysmal clipping surgeries looking into effects of various anesthetic agents on intraoperative (I/O) brain condition, I/O hemodynamic and POCD.Thus present study is planned to compare propofol and desflurane for long term postoperative cognitive decline in patients undergoing surgery following aneurysmal subarachnoid hemorrhage.
Detailed Description
100 patients will be randomized into two groups, Desflurane group (Group D) and Propofol group (Group P) using a computer generated algorithm. Written informed consent will be taken from all the patients.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Function
Keywords
POCD, subarachnoid hemorrhage, Propofol, Desflurane
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PROPOFOL
Arm Type
Active Comparator
Arm Description
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation
Arm Title
DESFLURANE
Arm Type
Active Comparator
Arm Description
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation
Intervention Type
Drug
Intervention Name(s)
Desflurane
Intervention Description
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
Primary Outcome Measure Information:
Title
Assessment of cognitive function at one month following surgery.
Description
Montreal Cognitive Assessment scale is used
Time Frame
One month
Secondary Outcome Measure Information:
Title
Assessment of cognitive function preoperatively Assessment of cognitive function at discharge. Comparison of biomarker of cognitive dysfunction
Description
Montreal Cognitive Assessment scale used
Time Frame
Baseline cognition assessment prior to surgery
Title
Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital
Description
Montreal Cognitive Assessment scale used
Time Frame
Discharge from hospital
Title
Comparison of biomarker (S-100B) levels
Description
Blood sample for S100B levels used
Time Frame
Prior to surgery , After clipping of aneurysm, One hour after completion of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled for aneurysmal SAH surgery with clinical and radiological evidence of cerebral aneurysm.
Age between 18 to 65 yrs.
World Federation of neurosurgery grade 1, 2.
American society of Anesthesia grade 1, 2 and 3.
Exclusion Criteria:
Co-morbidities other than hypertension and diabetes mellitus like cardiovascular disease and respiratory impairment.
Patients with known psychiatric disease.
History of drug abuse.
Low level of education (illiterate) or multiple failures in school.
Patients who are unconscious, intubated or tracheostomised even after two weeks following exposure to anesthesia will also be excluded from the study.
Intraoperative complications like massive blood loss, prolonged clipping time(>20minutes), severe intraoperative brain swelling precluding replacement of bone flap.
Patients with infectious diseases and respiratory complications.
Multiple surgeries.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shalvi Mahajan, MD
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hemant Bhagat, DM
Organizational Affiliation
Postgraduate Institute of Medical Education and Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Postgraduate institute of medical education and research
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
22851612
Citation
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.
Results Reference
result
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Comparison of Neuroprotection by Propofol and Desflurane for POCD Following Subarachnoid Hemorrhage Surgery
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