Trial Outcomes & Findings for Trajectory of Recovery in the Elderly (NCT NCT02275026)

Last Updated: 2021-06-15

Results Overview

Cognitive Function using scales of the PQRS to test whether age is associated with the time of return to baseline cognitive function. The PQRS is a brief measurement tool to assess multiple domains of recovery, including cognition, over time. It is scored as recovered / not recovered based on level of performance, within a certain tolerance range, relative to preoperative (baseline) performance - before the general anesthesia / MRI scanning session. Postoperative Quality of Recovery Cognitive Scale at each study timepoint by age decade. Postoperative Quality of Recovery Cognitive

Recruitment status

COMPLETED

Study phase

Target enrollment

104 participants

Primary outcome timeframe

15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months

Results posted on

2021-06-15

Participant Flow

Recruitment was completed in May 2019.

Participant milestones

Participant milestones
Measure	Functional Magnetic Resonance Imaging Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. Functional magnetic resonance imaging: Diffusion tensor imaging
Overall Study STARTED	104
Overall Study COMPLETED	71
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Functional Magnetic Resonance Imaging Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. Functional magnetic resonance imaging: Diffusion tensor imaging
Overall Study Ineligible after cognitive baseline testing	11
Overall Study Withdrawal by Subject	4
Overall Study Ineligible due to medical history	13
Overall Study MRI malfunction precluded testing	1
Overall Study Ineligible after MRI findings	1
Overall Study Lost to Follow-up	2
Overall Study Scanner failure	1

Baseline Characteristics

Trajectory of Recovery in the Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Functional Magnetic Resonance Imaging n=72 Participants Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. Functional magnetic resonance imaging: Diffusion tensor imaging
Age, Continuous	59 years n=39 Participants
Sex: Female, Male Female	30 Participants n=39 Participants
Sex: Female, Male Male	42 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	3 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants
Race (NIH/OMB) Black or African American	31 Participants n=39 Participants
Race (NIH/OMB) White	34 Participants n=39 Participants
Race (NIH/OMB) More than one race	3 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Body Mass Index (BMI)	26.5 kg/m^2 n=39 Participants
ASA Physical Status 1 - A normal healthy patient	57 Participants n=39 Participants
ASA Physical Status 2 - A patient with mild systemic disease without substantive functional limitations	15 Participants n=39 Participants
Disease History Hypertension	3 Participants n=39 Participants
Disease History Asthma	1 Participants n=39 Participants
Disease History Malignancy (any)	7 Participants n=39 Participants
Number of medications on initial assessment 0	61 Participants n=39 Participants
Number of medications on initial assessment 1	4 Participants n=39 Participants
Number of medications on initial assessment 2	6 Participants n=39 Participants
Number of medications on initial assessment 3+	1 Participants n=39 Participants

PRIMARY outcome

Timeframe: 15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months

Population: Scale could not be determined for 2 participants (1 in the 40-49 year age decade, one in the 70-80 year age decade).

Outcome measures

Outcome measures
Measure	Age Decade 40-49 n=19 Participants Groups divided by age decade	Age Decade 50-59 n=19 Participants Groups divided by age decade	Age Decade 60-69 n=13 Participants Groups divided by age decade	Age Decade 70-80 n=18 Participants Groups divided by age decade
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) at 15 min	3 Participants	5 Participants	1 Participants	3 Participants
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) at 60 min	8 Participants	11 Participants	8 Participants	9 Participants
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) 1 day	17 Participants	18 Participants	12 Participants	16 Participants
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) 3 days	18 Participants	19 Participants	12 Participants	17 Participants
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) 7 days	18 Participants	19 Participants	12 Participants	17 Participants
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) 30 days	18 Participants	19 Participants	12 Participants	18 Participants
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS) 6 months	19 Participants	19 Participants	13 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline, 1 day, 7 days, 30 days

NIH Toolbox Cognitive Battery is a multidimensional set of brief measures assessing cognitive (as well as emotional, motor and sensory) function. There is no score range, but mean score is 100 with standard deviation 15. A score at or near 100 indicates average ability compared with others. Scores around 115 suggest above-average ability. Scores around 130 suggest superior ability (in the top 2 percent nationally). A score around 85 suggests below-average ability. A score in the range of 70 or below suggests significant impairment.

Outcome measures

Outcome measures
Measure	Age Decade 40-49 n=20 Participants Groups divided by age decade	Age Decade 50-59 n=19 Participants Groups divided by age decade	Age Decade 60-69 n=13 Participants Groups divided by age decade	Age Decade 70-80 n=19 Participants Groups divided by age decade
Change in NIH Tool Box Composite Baseline	48.1 score on a scale Interval 45.3 to 51.0	53.3 score on a scale Interval 50.3 to 56.3	50.1 score on a scale Interval 16.5 to 53.7	54 score on a scale Interval 51.0 to 56.9
Change in NIH Tool Box Composite 1 day	52.2 score on a scale Interval 49.4 to 55.1	57.2 score on a scale Interval 54.2 to 60.2	53.2 score on a scale Interval 49.6 to 56.8	57.4 score on a scale Interval 54.4 to 60.3
Change in NIH Tool Box Composite 7 days	54.8 score on a scale Interval 52.0 to 57.7	59.4 score on a scale Interval 56.4 to 62.4	54.6 score on a scale Interval 50.9 to 58.2	54.4 score on a scale Interval 50.7 to 58.1
Change in NIH Tool Box Composite 30 days	54.5 score on a scale Interval 51.6 to 57.4	59.5 score on a scale Interval 56.5 to 62.5	54.4 score on a scale Interval 50.7 to 58.1	59.6 score on a scale Interval 56.7 to 62.6

Adverse Events

Functional Magnetic Resonance Imaging

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Functional Magnetic Resonance Imaging n=72 participants at risk Magnetic resonance images acquired on a 3 Tesla scanner (Skyra, Siemens, Erlangen, Germany) with a 20 channel receiver coil. Functional magnetic resonance imaging: Diffusion tensor imaging
Injury, poisoning and procedural complications Sore Throat	1.4% 1/72 • 30 days According to Michigan Awareness Classification Instrument
Gastrointestinal disorders Nausea	1.4% 1/72 • 30 days According to Michigan Awareness Classification Instrument
Eye disorders Eye discomfort	1.4% 1/72 • 30 days According to Michigan Awareness Classification Instrument
Nervous system disorders Lingual nerve compression injury	1.4% 1/72 • 30 days According to Michigan Awareness Classification Instrument

Additional Information

Dr. Joshua Mincer

Icahn School of Medicine at Mount Sinai

Phone: (917) 922-9475

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place