Trial Outcomes & Findings for Does Optimized General Anesthesia Care Reduce Postoperative Delirium? (NCT NCT02604459)

Last Updated: 2023-10-17

Results Overview

Delirium Rating Scale-Revised-98 (DRS-R-98) is a 16-item clinician-rated scale with 13 severity items and 3 diagnostic items (maximum severity score of 39 points). Higher scores indicate more severe delirium; score of 0 indicates no delirium. Only the number of patients who had high scores on the DRS-R-98 are reported.

Recruitment status

TERMINATED

Study phase

Target enrollment

145 participants

Primary outcome timeframe

5 postoperative days

Results posted on

2023-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Usual General Anesthesia Care Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane General anesthesia: General anesthesia will be used in both groups propofol: propofol per protocol fentanyl: fentanyl per protocol sevoflurane: maintenance of anesthesia with inhaled sevoflurane	Optimized General Anesthesia Care The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables. cerebral oximeter (Fore-Sight): The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher. depth of anesthesia monitor (BIS): The depth of anesthesia will be maintained between 40 and 60 in the optimized care group. BP management: The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group. General anesthesia: General anesthesia will be used in both groups propofol: propofol per protocol fentanyl: fentanyl per protocol sevoflurane: maintenance of anesthesia with inhaled sevoflurane	Mini-Mental State Examination If a patient is enrolled in the study, but scores \< 15 on the MMSE, they will remain in the study but will not be randomized to one of the treatment groups. They will receive the same type of general anesthesia for their hip fracture surgery as that done for randomized subjects. They will not be monitored with bispectral index or cerebral oximetry during the surgical procedure.	Tested and Excluded Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Overall Study STARTED	56	53	22	14
Overall Study COMPLETED	56	53	22	14
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Comparator: Usual General Anesthesia Care n=56 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Experimental: Optimized General Anesthesia Care n=53 Participants The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.	Mini Mental State Exam n=22 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Tested and Excluded n=14 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Total n=145 Participants Total of all reporting groups
Age, Continuous	78.1 years STANDARD_DEVIATION 8.4 • n=5 Participants	77.8 years STANDARD_DEVIATION 9.3 • n=7 Participants	86.6 years STANDARD_DEVIATION 6.8 • n=5 Participants	81 years STANDARD_DEVIATION 7.9 • n=4 Participants	78 years STANDARD_DEVIATION 8.9 • n=21 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	36 Participants n=7 Participants	17 Participants n=5 Participants	9 Participants n=4 Participants	105 Participants n=21 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	17 Participants n=7 Participants	5 Participants n=5 Participants	5 Participants n=4 Participants	40 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	53 Participants n=7 Participants	21 Participants n=5 Participants	13 Participants n=4 Participants	142 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System 2	8 Participants n=5 Participants	10 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System 3	39 Participants n=5 Participants	33 Participants n=7 Participants	16 Participants n=5 Participants	6 Participants n=4 Participants	94 Participants n=21 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System 4	9 Participants n=5 Participants	10 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	24 Participants n=21 Participants
American Society of Anesthesiologists (ASA) Physical Status Classification System 5	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants

PRIMARY outcome

Timeframe: 5 postoperative days

Population: Number of patients who presented with postoperative delirium and had high scores on the delirium test measures per group are indicated here. Patients who were excluded were not assessed for postoperative delirium.

Outcome measures

Outcome measures
Measure	Active Comparator: Usual General Anesthesia Care n=8 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Experimental: Optimized General Anesthesia Care n=4 Participants The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.	Mini Mental State Exam n=14 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane.	Tested and Excluded Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane.
Severity of Postoperative Delirium	0.14 score on a scale Standard Deviation 0.35	0.06 score on a scale Standard Deviation 0.23	0.63 score on a scale Standard Deviation 0.49	—

SECONDARY outcome

Timeframe: 5 postoperative days

Population: Number of patients who presented with postoperative delirium are reported. The patients who where tested and then excluded were not included in this analysis.

Confusion Assessment Method (CAM) with delirium scored as 'present' (1) or 'absent' (0) based on question responses; CAM is considered positive based on the CAM algorithm: presence of acute onset or fluctuating course, inattention, and disorganized thinking or altered level of consciousness.

Outcome measures

Outcome measures
Measure	Active Comparator: Usual General Anesthesia Care n=56 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Experimental: Optimized General Anesthesia Care n=53 Participants The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.	Mini Mental State Exam n=22 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane.	Tested and Excluded Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane.
Number of Patients Who Presented With Postoperative Delirium	8 Participants	4 Participants	0 Participants	—

SECONDARY outcome

Timeframe: preoperative, day of surgery, and postoperative day 2

Population: Lack of funding prevented the analysis of blood to obtain inflammatory markers.

Blood will be drawn for analysis of inflammatory markers including interleukin 6 (IL6), interleukin 10 (IL10), tumor necrosis factor (TNF) alpha on the day prior to surgery, at the end of surgery and on the second postoperative day.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months and 1 year

Population: Number analyzed in rows differs due to loss to follow-up. Patients who were excluded from the study were not followed op post operatively.

The investigators will make a telephone call to the subjects at 3 months and 1 year after surgery to determine if the subject has experienced any complications. We will ask the subjects about the occurrence of infections, strokes, cardiac problems, or respiratory problems since discharge from the hospital.

Outcome measures

Outcome measures
Measure	Active Comparator: Usual General Anesthesia Care n=56 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Experimental: Optimized General Anesthesia Care n=53 Participants The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.	Mini Mental State Exam n=22 Participants Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane.	Tested and Excluded Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane.
Number of Patients Who Experienced Postoperative Complications 1 Year: Cardiac arrest requiring cardiopulmonary resuscitation	2 Participants	0 Participants	2 Participants	—
Number of Patients Who Experienced Postoperative Complications 3 Months: Cardiac arrest requiring cardiopulmonary resuscitation	1 Participants	0 Participants	0 Participants	—
Number of Patients Who Experienced Postoperative Complications 3 Months: Myocardial infarction	1 Participants	1 Participants	1 Participants	—
Number of Patients Who Experienced Postoperative Complications 3 Months: Both cardiac arrest requiring cardiopulmonary resuscitation and myocardial infarction	0 Participants	0 Participants	0 Participants	—
Number of Patients Who Experienced Postoperative Complications 3 Months: Deep incisional surgical site infection	0 Participants	1 Participants	0 Participants	—
Number of Patients Who Experienced Postoperative Complications 3 Months: Organ/space surgical site infection	1 Participants	2 Participants	0 Participants	—
Number of Patients Who Experienced Postoperative Complications 1 Year: Myocardial infarction	0 Participants	1 Participants	0 Participants	—
Number of Patients Who Experienced Postoperative Complications 1 Year: Both cardiac arrest requiring cardiopulmonary resuscitation and myocardial infarction	1 Participants	0 Participants	0 Participants	—
Number of Patients Who Experienced Postoperative Complications 1 Year: Deep incisional surgical site infection	1 Participants	1 Participants	0 Participants	—
Number of Patients Who Experienced Postoperative Complications 1 Year: Organ/space surgical site infection	0 Participants	2 Participants	0 Participants	—

Adverse Events

Active Comparator: Usual General Anesthesia Care

Serious events: 26 serious events

Other events: 25 other events

Deaths: 8 deaths

Experimental: Optimized General Anesthesia Care

Serious events: 28 serious events

Other events: 20 other events

Deaths: 6 deaths

Mini Mental State Exam

Serious events: 11 serious events

Other events: 0 other events

Deaths: 10 deaths

Tested and Excluded

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Active Comparator: Usual General Anesthesia Care n=56 participants at risk Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Experimental: Optimized General Anesthesia Care n=53 participants at risk The subjects will have general anesthesia with propofol, fentanyl, sevoflurane. In addition the subjects will be monitored with a depth of anesthesia monitor (BIS) and a cerebral oximeter (Foresight). These additional monitors will be used to direct care. BP management: Systolic BP will be maintained within 20% of baseline systolic BP variables.	Mini Mental State Exam n=22 participants at risk Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane	Tested and Excluded Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider. General anesthesia with be maintained with propofol, fentanyl, sevoflurane
Infections and infestations Superficial incisional surgical site infection	0.00% 0/56 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	1.9% 1/53 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	0.00% 0/22 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	— 0/0 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.
Infections and infestations Urinary tract infection	5.4% 3/56 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	1.9% 1/53 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	0.00% 0/22 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	— 0/0 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.
Injury, poisoning and procedural complications Transfusion of packed red blood cells	37.5% 21/56 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	32.1% 17/53 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	0.00% 0/22 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	— 0/0 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.
Infections and infestations Organ/space surgical site infection	0.00% 0/56 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	1.9% 1/53 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	0.00% 0/22 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	— 0/0 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.
Injury, poisoning and procedural complications Fall	1.8% 1/56 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	0.00% 0/53 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	0.00% 0/22 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.	— 0/0 • 1 year Patients who were excluded from the study were not followed up for adverse events or all-cause mortality.

Additional Information

Dr. Quinn Johnson

University of Missouri

Phone: 573-882-2568

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place