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NCT Number: NCT02987218

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Postgraduate institute of medical education and research

Chandigarh, 160012, India

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propofol

Drug

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

Desflurane

Drug

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

Primary outcomes

  1. Assessment of cognitive function at one month following surgery.

    Time frame: One month

    Montreal Cognitive Assessment scale is used

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study title

Comparison Of Pharmacological Neuroprotection Provided By PROPOFOL VERSUS DESFLURANE For Long Term Postoperative Cognitive Dysfunction In Patients Undergoing Surgery For Aneurysmal Subarachnoid Hemorrhage

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 8, 2016
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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