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Modafinil to Prevent Postoperative Cognitive Decline

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Preoperative modafinil + postoperative placebo
Preoperative modafinil + postoperative modafinil
Preoperative placebo + postoperative placebo
Sponsored by
The Cooper Health System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cognitive Dysfunction

Eligibility Criteria

65 Years - 99 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists class I or II
  • Elective surgery

  • Surgery requiring general anesthesia

    4.) Control Group will be-females & males 65 and older not scheduled for any surgical procedures for at least a 3 month period.

Exclusion Criteria:

  • Neurosurgery
  • Cardiac surgery
  • Narcotic or illicit drug abuse
  • Chronic opioid use
  • Chronic use of anxiolytics
  • History of pulmonary disease
  • C02 retention
  • Sleep apnea
  • Obesity

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    No Intervention

    Arm Label

    Preoperative modafinil + postoperative placebo

    Preoperative modafinil + postoperative modafinil

    Preoperative placebo + postoperative placebo

    Control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Rey Auditory Verbal Learning Test (RAVLT) scores
    Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms. The RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively.

    Secondary Outcome Measures

    Full Information

    First Posted
    April 11, 2019
    Last Updated
    September 28, 2023
    Sponsor
    The Cooper Health System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03914118
    Brief Title
    Modafinil to Prevent Postoperative Cognitive Decline
    Official Title
    An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2008 (Actual)
    Primary Completion Date
    January 31, 2013 (Actual)
    Study Completion Date
    January 31, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The Cooper Health System

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Postoperative cognitive dysfunction is a well-recognized complication of surgery. The aim of the study is to investigate whether cognitive dysfunction is reduced by the use of modafinil as shown by neurocognitive testing.The treatment effects will be evaluated compared to placebo as well as a non-surgical group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Cognitive Dysfunction

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    137 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Preoperative modafinil + postoperative placebo
    Arm Type
    Active Comparator
    Arm Title
    Preoperative modafinil + postoperative modafinil
    Arm Type
    Active Comparator
    Arm Title
    Preoperative placebo + postoperative placebo
    Arm Type
    Placebo Comparator
    Arm Title
    Control group
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Preoperative modafinil + postoperative placebo
    Intervention Description
    200 mg modafinil pre-operatively and placebo immediately post-operatively.
    Intervention Type
    Drug
    Intervention Name(s)
    Preoperative modafinil + postoperative modafinil
    Intervention Description
    200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.
    Intervention Type
    Drug
    Intervention Name(s)
    Preoperative placebo + postoperative placebo
    Intervention Description
    Placebo pre-operatively and placebo immediately post-operatively.
    Primary Outcome Measure Information:
    Title
    Rey Auditory Verbal Learning Test (RAVLT) scores
    Description
    Rey Auditory Verbal Learning Test (RAVLT) scores will be used to assess memory and learning ability in the auditory-verbal domain. The RAVLT begins with a list of 15 words, which an examiner reads aloud at the rate of one per second. The patient's task is to repeat all the words he or she can remember, in any order. This procedure is carried out a total of five times. Then, the examiner presents a second list of 15 words, allowing the patient only one attempt at recall. Immediately following this, the patient is asked to remember as many words as possible from the first list. For each trial a maximum score of 15 can be obtained, which would reflect excellent memory. The obtained scores per individual trial will be compared between the 4 different arms. The RAVLT will be administered preoperatively, immediately postoperatively in the PACU (except the non-surgical control group), at 1 week and at 3 months postoperatively.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: American Society of Anesthesiologists class I or II Elective surgery Surgery requiring general anesthesia 4.) Control Group will be-females & males 65 and older not scheduled for any surgical procedures for at least a 3 month period. Exclusion Criteria: Neurosurgery Cardiac surgery Narcotic or illicit drug abuse Chronic opioid use Chronic use of anxiolytics History of pulmonary disease C02 retention Sleep apnea Obesity

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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