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

Postoperative Cognitive Function Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02987218
• Other study ID #: INT/IEC/2015/741
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2016
• Last updated: December 6, 2016
• Start date: July 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemorrhage
• Postoperative Cognitive Function
• Subarachnoid Hemorrhage

Intervention

Drug:
• Propofol
Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation
• Desflurane
Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation

Locations

Country	Name	City	State
India	Postgraduate institute of medical education and research	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & 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: p — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of cognitive function at one month following surgery.	Montreal Cognitive Assessment scale is used	One month	Yes
Secondary	Assessment of cognitive function preoperatively Assessment of cognitive function at discharge. Comparison of biomarker of cognitive dysfunction	Montreal Cognitive Assessment scale used	Baseline cognition assessment prior to surgery	Yes
Secondary	Assessment of cognitive function preoperatively Assessment of cognitive function at the time of discharge from hospital	Montreal Cognitive Assessment scale used	Discharge from hospital	Yes
Secondary	Comparison of biomarker (S-100B) levels	Blood sample for S100B levels used	Prior to surgery , After clipping of aneurysm, One hour after completion of surgery	Yes