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Trial record 5 of 28 for:    mahajan

Comparison of Neuroprotection by Propofol and Desflurane for POCD Following Subarachnoid Hemorrhage Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Shalvi mahajan, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT02987218
First received: November 13, 2016
Last updated: December 6, 2016
Last verified: December 2016
  Purpose
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.

Condition Intervention Phase
Postoperative Cognitive Function
Drug: Propofol
Drug: Desflurane
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • Assessment of cognitive function at one month following surgery. [ Time Frame: One month ]
    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 [ Time Frame: Baseline cognition assessment prior to surgery ]
    Montreal Cognitive Assessment scale used

  • Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital [ Time Frame: Discharge from hospital ]
    Montreal Cognitive Assessment scale used

  • Comparison of biomarker (S-100B) levels [ Time Frame: Prior to surgery , After clipping of aneurysm, One hour after completion of surgery ]
    Blood sample for S100B levels used


Enrollment: 100
Study Start Date: July 2015
Study Completion Date: November 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PROPOFOL
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation
Drug: Propofol
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation
Active Comparator: DESFLURANE
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
Drug: Desflurane
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients scheduled for aneurysmal SAH surgery with clinical and radiological evidence of cerebral aneurysm.
  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:

  1. Co-morbidities other than hypertension and diabetes mellitus like cardiovascular disease and respiratory impairment.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02987218

Locations
India
Postgraduate institute of medical education and research
Chandigarh, India, 160012
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Investigators
Principal Investigator: Shalvi Mahajan, MD Postgraduate Institute of Medical Education and Research
Principal Investigator: Hemant Bhagat, DM Postgraduate Institute of Medical Education and Research
  More Information

Publications:
Responsible Party: Dr Shalvi mahajan, Senior Resident, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT02987218     History of Changes
Other Study ID Numbers: INT/IEC/2015/741
Study First Received: November 13, 2016
Last Updated: December 6, 2016
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Postgraduate Institute of Medical Education and Research:
POCD
subarachnoid hemorrhage
Propofol
Desflurane

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Propofol
Desflurane
Isoflurane
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anesthetics, Inhalation

ClinicalTrials.gov processed this record on March 24, 2017