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

NCT02428972 | Unknown DMC

• 1 other identifier: IEC/NP-55/06.02.2015
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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

Brain Tumor

Keywords

brain tumor; quality of life; cognition; anesthetic technique

Outcome Measures

Primary Outcomes (1)

• Cognitive functions

  Six month.

Secondary Outcomes (1)

• Adverse events

  24 hours

Study Arms (2)

intravenous anesthesia

EXPERIMENTAL

propofol infusion @ 100-200 mcg/kg/min for maintenance of anesthesia

Drug: Propofol

inhalational anesthesia

ACTIVE COMPARATOR

sevoflurane MAC between 0.8-1.2 for maintenance of anesthesia

Drug: Sevoflurane

Interventions

Propofol DRUG

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

Also known as: 2,6-di(propan-2-yl)phenol

intravenous anesthesia

Sevoflurane DRUG

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

Also known as: fluoromethyl hexafluoroisopropyl ether

inhalational anesthesia

Eligibility Criteria

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

You may qualify if:

• All adult patients between 18 - 65 years, of either gender scheduled for craniotomy for supratentorial brain tumors.

You may not qualify if:

• Patients with a history of previous surgery for brain tumor, emergency surgery and non-consenting patients.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Propofol; Sevoflurane

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Indu Kapoor, MD

  All India Institute of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Indu Kapoor, MD

CONTACT

9868398586; dr.indu.me@gmail.com

Hemanshu Prabhakar, MD

CONTACT

9868398205; prabhakaraiims@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 8, 2015
• First Posted: April 29, 2015
• Study Start: August 1, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share