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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02604459
Other study ID # 1212915
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date June 1, 2015
Est. completion date February 28, 2018

Study information

Verified date September 2023
Source University of Missouri-Columbia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 145
Est. completion date February 28, 2018
Est. primary completion date February 28, 2018
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.
General anesthesia
General anesthesia will be used in both groups
Drug:
propofol
propofol per protocol
fentanyl
fentanyl per protocol
sevoflurane
maintenance of anesthesia with inhaled sevoflurane

Locations

Country Name City State
United States University of Missouri Hospitals Columbia Missouri

Sponsors (1)

Lead Sponsor Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Severity of Postoperative Delirium 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. 5 postoperative days
Secondary Number of Patients Who Presented With Postoperative Delirium 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. 5 postoperative days
Secondary Perioperative Inflammatory Response 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. preoperative, day of surgery, and postoperative day 2
Secondary Number of Patients Who Experienced Postoperative Complications 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. 3 months and 1 year
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