MedTrace Logo

Assessment of Cognitive Functions and Quality of Life in Patients Undergoing Surgery for Supratentorial Brain Tumor

NCT02428972 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-01-24

No results posted yet for this study

Summary

Primary brain tumors are highly associated with neurocognitive deficit and poor quality of life. There are number of studies indicating that brain tumors and their treatment modalities are often related to cognitive dysfunction. Apart from primary brain lesions, deficit can also occur because of Surgery, Radiotherapy, Chemotherapy, Antiepileptic and Corticosteroid treatment.Anaesthesia can also add to cognitive deficit in these patients. According to Ali et al. propofol provides better cognition scores compared to sevoflurane than isoflurane. The primary aim of their study was to compare the effects of 3 anesthetic regimens on hemodynamics and recovery characteristics of the patients. However in another study by Magni et al., the authors found that there is no difference in early cognitive function between sevoflurane and propofol. The aim of this prospective, randomized, open-label clinical trial was to compare clinical properties of sevoflurane-fentanyl with propofol-remifentanil anesthesia in patients undergoing supratentorial intracranial surgery. However both these studies evaluated the early cognitive function. The primary endpoint was to compare early postoperative recovery and cognitive functions within the two groups. They also evaluated hemodynamic events, vomiting, shivering, and pain. The literature is scarce on the severity, incidence and effect of anaesthetics on cognition and quality of life of these patients. Since most of the patients of brain tumor cannot be cured with surgery alone, improvement of quality of life and palliative care of the symptoms and cognitive function are important part of the treatment. Now the cognitive function has also been considered as an independent prognostic factor in the survival of patients of brain tumor. Cognitive function can also be related to tumor laterality. Patients with tumors in left hemisphere will have lower scores on verbal tests, whereas tumor in right hemisphere will have lower scores on facial recognition tests. Patients with tumors in the left hemisphere report more difficulty concentrating and those with right-hemisphere lesions,report more tension. Patients with primary brain tumors also experience serious challenges to their quality of life (QOL). These patients may face motor deficits, personality changes, cognitive deficits, aphasia, or visual field defects.

Conditions

Interventions

DRUG

Propofol

Propofol infusion @100-200 mcg/kg/min Fentanyl 1mcg/kg Vecuronium 0.1mg/kg Mannitol 1 gm/kg

DRUG

Sevoflurane

MAC of Sevoflurane will be maintained between 0.8-1.2 Fentanyl 1mcg/kg Vecuronium 0.1mg/kg Mannitol 1 gm/kg

Sponsors & Collaborators

  • All India Institute of Medical Sciences

    lead OTHER

Principal Investigators

  • Indu Kapoor, MD · All India Institute of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-07-31
Completion
2018-07-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428972 on ClinicalTrials.gov