A Trial To Assess Risk of Delirium in Older Adults Undergoing Hip Fracture Surgery With Spinal or General Anesthesia

Objectives Overall objectives Overall Objectives Specific Aims

1. To compare the effect of spinal versus general anesthesia on rates of postoperative
delirium after hip fracture surgery. We hypothesize that rates of delirium after hip
fracture surgery will be lower among patients receiving spinal versus general
anesthesia.

2. To develop, field-test, and conduct a qualitative evaluation of protocols and procedures
for a planned multicenter trial to test the association of anesthesia technique with
survival and recovery of function in activities of daily living ambulatory ability at
six months after hip fracture.

Primary outcome variable(s) The primary outcome variable is the rate of delirium after hip
fracture surgery.

Background Delirium, or a disturbance of consciousness and a change in cognition that develop
over a short period of time, (1) complicates 2.6 million hospitalizations among U.S. adults
aged 65 or older each year. (2,3) Patients who experience delirium during hospitalization
face increased risks morbidity, mortality, and functional disability. (4) Each year, delirium
accounts for $6.9 billion in Medicare hospital expenditures. (5) Delirium occurs in 35% to
65% of the 320,000 older U.S. adults hospitalized for hip fracture each year. (6) While
adverse survival and functional outcomes are common after hip fracture, (7) a single episode
of delirium doubles the odds of both new functional dependence and new ambulatory disability
at six months after fracture, and triples the odds of death or new nursing home placement.
(8) Compared to general endotracheal anesthesia, spinal anesthesia may decrease the incidence
of postoperative delirium after hip fracture surgery. Small randomized trials of anesthesia
type for hip fracture have suggested a 50% lower risk of acute confusion after hip fracture
surgery with spinal anesthesia, (9) but the heterogeneity of outcome definitions and
measurement strategies employed by past trials, along with their use of historical anesthesia
practices limit their applicability to current practice.

As a result of these limitations, clinical equipoise continues to exist regarding the optimal
anesthetic technique for hip fracture care. Compared to general anesthesia, spinal anesthesia
may offer potential benefits not limited to decreased delirium. These may include decreased
intraoperative blood loss, and decreased risks of postoperative thromboembolic events,
respiratory infections and malignant hyperthermia. At the same time, spinal anesthesia may be
associated with greater hypotension than general anesthesia, and may carry small risks of
bleeding and infection at the site of the spinal injection and discomfort during block
placement. Relative to spinal anesthesia, general anesthesia may offer benefits of
hemodynamic stability. At present, while spinal anesthesia has been demonstrated in a
retrospective observational study to be associated with lower in-hospital mortality after hip
fracture (10), a meta-analysis of randomized trials was inconclusive with regard to mortality
differences. (9) Reflecting this state of clinical equipoise patterns of anesthesia care
differ widely by country and by provider, reflecting a large role of provider practice style
in determining anesthesia care for hip fracture. For example, in a recent survey of UK
anesthesiologists, 76% indicated that they routinely performed hip fracture surgeries with
spinal anesthesia (11). In contrast, recent U.S. data suggest that approximately 80% of hip
fracture surgeries are performed with general anesthesia, with wide variability in practice
across hospitals.(10) While these variations may in part reflect differences in patient
preferences, the current state of knowledge regarding the risks and benefits of differing
types of anesthesia is inadequate to support appropriately informed medical decision-making
by either patients or health care providers. The UKs national institute for Health and Care
Excellence (NICE) strongly recommend further clinical trials to provide additional
information regarding the clinical and cost effectiveness of differing anesthesia types for
hip fracture, stating that they were unable to identify any recent randomised controlled
trialsthat fully address this question and that the [available] evidence is old and does not
reflect current practice.

Study Design Phase II

Design This is a randomized, controlled trial of spinal versus general anesthesia to test the
effect of anesthesia type on rates of postoperative delirium after hip fracture surgery.

Study duration It is expected that this study will begin enrollment in June 2013. The
enrollment of all subjects is projected to be completed in May 2014 with data analysis to
follow. The study will hope to be completed by June 2015.

The length of participation for each subject will be about 5 days.

Inclusion Criteria:

1. Subject is aged 18 and older.

2. Subject is scheduled to undergo surgical treatment of an acute femoral neck or
pertrochanteric hip fracture.

3. Subject can speak English

4. Subject has ability to sign informed consent

Exclusion Criteria:

1. Subject has a pathological or periprosthetic fracture.

2. Subject has concurrent conditions anticipated at the time of admission to require
surgical treatment (e.g. multiple trauma, acute cholecystitis).

3. Subject has severe cognitive impairment, as evidenced by a Montreal Cognitive
Assessment Score (MOCA) of 15 or less.

4. Subject has clinical findings of delirium prior to surgery, as evidenced by a positive
Confusion Assessment Method (CAM) evaluation;

5. Subject has contraindications to spinal anesthesia or volatile general anesthetics.