Does Optimized General Anesthesia Care Reduce Postoperative Delirium?

Anesthesia Clinical Trial

— OPCare  

Official title:

Does Optimized General Anesthesia Care Reduce Postoperative Delirium In Older Patients Undergoing Hip Fracture Repair?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02604459
• Other study ID #: 1212915
• Status: Terminated
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia
• Delirium
• Emergence Delirium
• Hip Fractures

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