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

NCT02987218 | Completed Phase 4 DMC

• 1 other identifier: INT/IEC/2015/741
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Cognitive Function

Keywords

POCD; subarachnoid hemorrhage; Propofol; Desflurane

Outcome Measures

Primary Outcomes (1)

• Assessment of cognitive function at one month following surgery.

  Montreal Cognitive Assessment scale is used

  One month

Secondary Outcomes (3)

• Assessment of cognitive function preoperatively Assessment of cognitive function at discharge. Comparison of biomarker of cognitive dysfunction

  Baseline cognition assessment prior to surgery

• Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital

  Discharge from hospital

• Comparison of biomarker (S-100B) levels

  Prior to surgery , After clipping of aneurysm, One hour after completion of surgery

Study Arms (2)

PROPOFOL

ACTIVE COMPARATOR

Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP(Intracranial pressure) Better cognitive Function preservation

Drug: Propofol

DESFLURANE

ACTIVE COMPARATOR

Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation

Drug: Desflurane

Interventions

Propofol DRUG

Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation

PROPOFOL

Desflurane DRUG

Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation

DESFLURANE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Postgraduate institute of medical education and research

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (1)

• 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.

  PMID: 22851612 RESULT

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Propofol; Desflurane

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ethyl Ethers; Ethers; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Shalvi Mahajan, MD

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

• Hemant Bhagat, DM

  Post Graduate Institute of Medical Education and Research, Chandigarh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: November 13, 2016
• First Posted: December 8, 2016
• Study Start: July 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)