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

December 6, 2016 updated by: Dr Shalvi mahajan, Postgraduate Institute of Medical Education and Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Chandigarh, India, 160012
        • Postgraduate Institute of Medical Education and Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of cognitive function at one month following surgery.
Time Frame: One month
Montreal Cognitive Assessment scale is used
One month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline cognition assessment prior to surgery
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
Discharge from hospital
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
Prior to surgery , After clipping of aneurysm, One hour after completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

November 1, 2016

Study Registration Dates

First Submitted

November 13, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (ESTIMATE)

December 8, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 6, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INT/IEC/2015/741

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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