Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2018-02-28

Brief Summary

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Postoperative delirium occurs in up to 65% of elders undergoing surgery for repair of a hip fracture and this complication is independently associated with increased morbidity, mortality, length of hospital stay, and placement in long-term care institutions. To date, the only intervention shown to be effective at minimizing postoperative delirium is a proactive geriatric consultation. This prospective randomized clinical trial will randomize 160 adults, aged 65 years or older, to either optimized general anesthesia or usual general anesthesia care for hip fracture surgery to determine if the optimized anesthesia management reduces the severity of postoperative delirium.

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Detailed Description

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Subjects will be randomized to one of two intraoperative anesthesia treatment groups: 1.) Usual care - the anesthetic management will be at the discretion of the anesthesia provider; or 1.) Optimal care - the intraoperative depth of anesthesia will be directed using a BIS monitor, blood pressure will be maintained within 20% of preoperative levels, and cerebral oxygenation will be maintained \> 60% during anesthesia. Subjects will be evaluated using the Confusion Assessment Method (CAM) for the first 5 postoperative days to determine if they experience postoperative delirium.

Conditions

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Hip Fractures Anesthesia Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The individuals assessing the patients for delirium after surgery will be unaware of the treatment in the operating room.

Study Groups

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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

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type PROCEDURE

General anesthesia will be used in both groups

propofol

Intervention Type DRUG

propofol per protocol

fentanyl

Intervention Type DRUG

fentanyl per protocol

sevoflurane

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

cerebral oximeter (Fore-Sight)

Intervention Type DEVICE

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)

Intervention Type DEVICE

The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.

BP management

Intervention Type PROCEDURE

The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.

General anesthesia

Intervention Type PROCEDURE

General anesthesia will be used in both groups

propofol

Intervention Type DRUG

propofol per protocol

fentanyl

Intervention Type DRUG

fentanyl per protocol

sevoflurane

Intervention Type DRUG

maintenance of anesthesia with inhaled sevoflurane

Mini Mental State Exam

Subjects will have their general anesthetic management directed at the discretion of the anesthesia provider.

General anesthesia with be maintained with propofol, fentanyl, sevoflurane

Group Type ACTIVE_COMPARATOR

General anesthesia

Intervention Type PROCEDURE

General anesthesia will be used in both groups

propofol

Intervention Type DRUG

propofol per protocol

fentanyl

Intervention Type DRUG

fentanyl per protocol

sevoflurane

Intervention Type DRUG

maintenance of anesthesia with inhaled 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

Group Type OTHER

General anesthesia

Intervention Type PROCEDURE

General anesthesia will be used in both groups

propofol

Intervention Type DRUG

propofol per protocol

fentanyl

Intervention Type DRUG

fentanyl per protocol

sevoflurane

Intervention Type DRUG

maintenance of anesthesia with inhaled sevoflurane

Interventions

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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.

Intervention Type DEVICE

depth of anesthesia monitor (BIS)

The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.

Intervention Type DEVICE

BP management

The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.

Intervention Type PROCEDURE

General anesthesia

General anesthesia will be used in both groups

Intervention Type PROCEDURE

propofol

propofol per protocol

Intervention Type DRUG

fentanyl

fentanyl per protocol

Intervention Type DRUG

sevoflurane

maintenance of anesthesia with inhaled sevoflurane

Intervention Type DRUG

Other Intervention Names

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diprivan sublimaze ultane

Eligibility Criteria

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Inclusion Criteria

* Subject or legal representative has voluntarily signed the informed consent approved by the Institutional Review Board,
* Hip fracture surgery scheduled under general anesthesia
* Subject is 65 years or older on the day of surgery

Exclusion Criteria

* Inability to follow directions or comprehend the English language
* Severe uncorrected visual or auditory handicaps
* Delirium at screening or baseline
* Emergency surgery

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No