Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

NCT02604459 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2023-10-17

Study results available
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Summary

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.

Conditions

  • Hip Fractures
  • Anesthesia
  • Delirium

Interventions

DEVICE

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.

DEVICE

depth of anesthesia monitor (BIS)

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

PROCEDURE

BP management

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

PROCEDURE

General anesthesia

General anesthesia will be used in both groups

DRUG

propofol

propofol per protocol

DRUG

fentanyl

fentanyl per protocol

DRUG

sevoflurane

maintenance of anesthesia with inhaled sevoflurane

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Quinn L Johnson, MD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-01
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02604459 on ClinicalTrials.gov