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

January 23, 2017 updated by: Indu Kapoor, All India Institute of Medical Sciences, New Delhi

Assessment of Cognitive Functions and Quality of Life in Patients Undergoing Surgery for Supratentorial Brain Tumor - a Comparison of Two Anaesthetic Techniques

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cognitive dysfunction is a common complication in primary or metastatic brain tumors and can be correlated to disease itself or various treatment modalities. The symptoms of cognitive deficits may include problems with memory, attention and information processing. There is a study which suggest that psychological distress is an important factor in reducing health related QOL in patients with brain tumors. However in some studies, depression was found to be another important independent predictor of QOL and has strong impact on survival. QOL is a extensive term that comprises physical or functional status, emotional well-being, and social well-being. It has been studied that QOL in patients with high-grade tumors do not differ those with grade III and grade IV tumors. Compared to patients with non-CNS cancers, brain tumor patients report more fatigue, cognitive dysfunction, and altered mood states. However, different levels of impairments have been observed in patients with brain tumors. To spread awareness of the illness, psychiatric interventions may be useful in these patients. Cognitive dysfunction may affect basic functions including attention or behavior or advanced functions like taking decisions or making plans. According to Yoshii Y et.al, Cognitive dysfunction before or after the surgery may not correlate with stage of tumor malignancy and degree of tumor resection. Cognitive function has been correlated to increased fatigue and depression in newly diagnosed malignant glioma patients.

After approval from Institute Ethics Committee and consent from the patient or guardian, we will include all adult patients between 18 - 65 years, of either gender scheduled for craniotomy for supratentorial brain tumors. We will exclude patients with a history of previous surgery for brain tumor, emergency surgery and non-consenting patients. To calculate the sample size we will first conduct a pilot study enrolling 30 patients, 15 in each group. Block randomization will be followed with blocks size of 10 patients. Patients will be randomized using the computer generated program. Demographic details will be noted. Patients will be adequately fasted prior to elective surgery. A standard anaesthesia protocol will be followed for all patients. Patients will be randomized in to two groups, Group S (Inhalational) and Group P (Intravenous). .Allocation of the group will be performed using an opaque sealed envelope method. General anaesthesia will be induced with Propofol 1.5 - 2 mg/kg.Anaesthesia will be maintained with either propofol (Group P) or Sevoflurane (Group S) along with mixture of oxygen and air [1:1] at flow rate of 2 liters per minute..The Minimum Alveolar Concentration (MAC) of Sevoflurane would be maintained between 0.8 - 1.2. In Group P, depth of anaesthesia will be guided by clinical signs such as tachycardia and hypertension. Intra-operative analgesia and muscle relaxation will be provided by boluses of fentanyl 1 mcg/kg and vecuronium 0.1 mg/kg, respectively. Intra-operative monitoring will include ECG, heart rate, invasive and non-invasive blood pressure, gases, end-tidal carbon dioxide, pulse oximetry, temperature and fluid input and output. Mannitol 1 gm/kg would be administered over a period of 20 minutes at the time of skin incision. Immediately after craniotomy, brain relaxation would be assessed using Brain Relaxation Score (BRS) in which the blinded surgeon will assess the condition of the brain as 1 = perfectly relaxed, 2 = satisfactorily relaxed, 3 = firm (leveled) brain, 4 = bulging brain.(27)At the end of surgery, propofol would be discontinued at the beginning of skin closure and Sevoflurane at the end of the skin closure. Neuromuscular block will be reversed with neostigmine 0.1 mg/kg and glycopyrrolate 0.01 mg/kg. If patients are planned for elective mechanical ventilation in the post-operative period, neuromuscular block will not be reversed.

Emergence and extubation times will be noted. Emergence time is defined as time from discontinuation of anaesthetic to time to follow verbal commands and eye opening. Extubation time is defined as time from anesthetic discontinuation to tracheal extubation. Recovery of the patient will be assessed using the modified Aldrete score. Intraoperative and postoperative complications, if any, will be noted. Various complications (tachycardia, bradycardia, hypotension, hypertension) will be treated with fentanyl, atropine, mephentramine and labetalol. All patients will be shifted to the ICU for supportive care and further management. Cognitive functions would be assessed preoperatively (baseline), between 2 to 3 hours postoperative, 24 hours post-operative, three months and six month. Quality of life (QOL) will be assessed at three month, six month and one year. Cognitive function will be assessed for memory, learning, executive functioning, sustained attention and verbal fluency and QOL by neuro-psychologist as shown in Appendix below. The difference of brain relaxation by two grades between the two study groups will be considered clinically significant and sample size calculated on this basis.

Appendix

NEUROPSYCHOLOGICAL ASSESSMENT

FUNCTION TEST [1]: Memory & Learning, TEST: Auditory Verbal Learning Test (AVLT), DOMAINS: Verbal Memory, Learning & Retention, TIME TAKEN: 20 minutes, AVAILABILITY: Property of Clinical Neuropsychology (CNP). FUNCTION TEST [2]: Executive Functioning, TEST: Stroop Test, DOMAINS: Response Inhibition, perceptual set, TIME TAKEN:10 minutes, AVAILABILITY: Property of Clinical Neuropsychology (CNP). FUNCTION TEST [3]: Speed, TEST: Digit Symbol Substitution Test (DSST), DOMAINS: Mental speed, visuomotor coordination, motor persistence, sustained attention, response speed, TIME TAKEN:10 minutes, AVAILABILITY: Property of Clinical Neuropsychology (CNP). FUNCTION TEST [4]: Verbal Fluency, TEST: Controlled Oral Word Association (COWA) Test, DOMAINS: Phonemic fluency, language, TIME TAKEN:5 minutes, AVAILABILITY: Property of Clinical Neuropsychology (CNP). FUNCTION TEST [5]: Quality of life, TEST: WHO QOL - BREF, DOMAINS: QOL, TIME TAKEN:5 minutes, AVAILABILITY: Property of Clinical Neuropsychology (CNP).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: intravenous anesthesia
propofol infusion @ 100-200 mcg/kg/min for maintenance of anesthesia
Drug: Propofol
Propofol infusion @100-200 mcg/kg/min Fentanyl 1mcg/kg Vecuronium 0.1mg/kg Mannitol 1 gm/kg
Other Names:
  • 2,6-di(propan-2-yl)phenol
Active Comparator: inhalational anesthesia
sevoflurane MAC between 0.8-1.2 for maintenance of anesthesia
Drug: Sevoflurane
MAC of Sevoflurane will be maintained between 0.8-1.2 Fentanyl 1mcg/kg Vecuronium 0.1mg/kg Mannitol 1 gm/kg
Other Names:
  • fluoromethyl hexafluoroisopropyl ether

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cognitive functions
Time Frame: Six month.
Six month.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: 24 hours
Number of patients suffering delay in emergence, hemodynamic instability, nausea, vomiting, pneumocephalus.
24 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
All India Institute of Medical Sciences, New Delhi

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 (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 8, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IEC/NP-55/06.02.2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Brain Tumor

Clinical Trials on Propofol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings