Trial Outcomes & Findings for Desflurane or Propofol Anesthesia in Elderly Obese Patients Undergoing Total Knee Replacement (NCT NCT01270620)

NCT ID: NCT01270620

Last Updated: 2015-10-22

Results Overview

The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2015-10-22

Participant Flow

One hundred patients provided consented to participate in the study during June 2010 to August 2014.

Participant milestones

Measure	Desflurane Group Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring. Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol Group Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring. Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Overall Study STARTED	50	50
Overall Study COMPLETED	49	47
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	Desflurane Group Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring. Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol Group Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring. Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Overall Study Withdrawal by Subject	1	3

Baseline Characteristics

Desflurane or Propofol Anesthesia in Elderly Obese Patients Undergoing Total Knee Replacement

Baseline characteristics by cohort

Measure	Desflurane n=50 Participants Patients received propofol or desflurane as general anesthetic for total knee replacement. Inclusion criteria: Age \> 65 years old; BMI \> 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III	Propofol n=50 Participants Patients received propofol or desflurane as general anesthetic for total knee replacement. Inclusion criteria: Age \> 65 years old; BMI \> 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Continuous	70 years STANDARD_DEVIATION 4.0 • n=5 Participants	71 years STANDARD_DEVIATION 5.8 • n=7 Participants	70.5 years STANDARD_DEVIATION 4.6 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	34 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	16 Participants n=7 Participants	45 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants	50 participants n=7 Participants	100 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

The primary end point was the incidence of postoperative delirium as measured by the Confusion Assessment Method (CAM).

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Assessment of Delirium	0 participants	0 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 6-8 hours after surgery

• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Recall of Digit Span	11 participants	8 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 48 hours after surgery

• The Digit Span subtest of the Wechsler Adult Intelligence Scale-Revised is a test that requires subjects to repeat a series of digits that have been verbally presented to them both forward and, in a later independent test, reverse order. It measures attention and working memory

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Recall of Digit Span	10 participants	9 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 6-8 hours after surgery

• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Digit Symbol Substitution Test	22 participants	17 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 48 hours after surgery

• The Digit Symbol Substitution Test (DSST) measures attention, working memory, sustained visual attention and psychomotor speed. Subjects are given a table that pairs digits and symbols, and asked to decipher a code using the table, completing as many as possible in 90 seconds. The DSST has been found to be more sensitive than other tests to changes in high-levels of cognition

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Digit Symbol Substitution Test	24 participants	16 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 6-8 hours after surgery

• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Trail Making Part A	25 participants	25 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 48 hours after surgery

• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail A requires the subject to rapidly sequence a straightforward series. The scoring for this test is the time in seconds required for completion of the test

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Trail Making Part A	26 participants	19 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 6-8 hours after surgery

• Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Trail Making Part B	29 participants	22 participants

PRIMARY outcome

Timeframe: Change > 20% from baseline to 48 hours after surgery

Trail Making Test is an executive measure of sequencing and cognitive flexibility. Trail B is a more difficult cognitive flexibility task requiring the subject to follow a sequential pattern while shifting cognitive sets and reflects executive functioning, although other cognitive abilities, such as psychomotor speed and visual scanning, are necessary for successful completion of the task. The scoring for this test is the time in seconds required for completion of the test

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Trail Making Part B	29 participants	22 participants

SECONDARY outcome

Timeframe: first day

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
- Time to Spontaneous Breathing After Desflurane/Propofol Discontinuation	270 seconds Interval 120.0 to 480.0	300 seconds Interval 120.0 to 465.0

SECONDARY outcome

Timeframe: first day

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
- Time to Eye Opening After Desflurane/Propofol Discontinuation	420 seconds Interval 240.0 to 600.0	395 seconds Interval 180.0 to 655.0

SECONDARY outcome

Timeframe: first day

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
- Time to Tracheal Extubation After Desflurane/Propofol Discontinuation	420 seconds Interval 300.0 to 600.0	526 seconds Interval 300.0 to 720.0

SECONDARY outcome

Timeframe: first day

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
- Time to Following Command After Desflurane/Propofol Discontinuation	480 seconds Interval 300.0 to 600.0	450 seconds Interval 240.0 to 660.0

SECONDARY outcome

Timeframe: 48 hours

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Nausea and Vomiting	3 participants	4 participants

SECONDARY outcome

Timeframe: first day

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Recovery Room Time	65 minutes Interval 46.0 to 76.0	60.5 minutes Interval 45.0 to 83.75

SECONDARY outcome

Timeframe: Change from Baseline to day one

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
B-type Natriuretic Peptide	47 ng/L Interval 31.0 to 76.0	43 ng/L Interval 14.5 to 77.5

SECONDARY outcome

Timeframe: Change from baseline to day one

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
N-terminal proBNP	83 ng/L Interval 46.0 to 159.0	86 ng/L Interval 9.0 to 194.0

SECONDARY outcome

Timeframe: 2 days

Patients who had troponin level > 0.2 ng/mL

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Troponin I	1 participants	0 participants

SECONDARY outcome

Timeframe: Change form baseline to post-operative day 2

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
BNP	83.5 ng/L Interval 35.5 to 174.0	92 ng/L Interval 45.5 to 196.5

SECONDARY outcome

Timeframe: Change from baseline to post-operative day 2

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
ProBNP	330 ng/L Interval 147.0 to 682.5	311.5 ng/L Interval 153.8 to 573.2

SECONDARY outcome

Timeframe: Time from Incision to closure of surgery

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Duration of Surgery	103.5 minutes Interval 91.5 to 117.0	95 minutes Interval 84.25 to 123.0

SECONDARY outcome

Timeframe: Time from induction to extubation

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Duration of Anesthesia	137.5 minutes Interval 121.2 to 156.5	133.5 minutes Interval 115.0 to 159.2

SECONDARY outcome

Timeframe: From the anesthesia induction until extubation

Outcome measures

Measure	Desflurane n=49 Participants Patients received desflurane as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia	Propofol n=47 Participants Patients received propofol as general anesthetic propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
Amount of Intraoperative Fentanyl	350 micrograms Interval 250.0 to 418.8	350 micrograms Interval 300.0 to 450.0

Adverse Events

Desflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Propofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Pedro Tanaka

Stanford University School of Medicine

Phone: 6507244066

Email: ptanaka@stanford.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place