Cerebral Oxygen Desaturation, Post-operative Delirium
Conditions
Brief summary
We plan to investigate the relationship between hypotensive epidural anesthesia for hip arthroplasty and cerebral oxygen saturation.
Detailed description
The relationship between cerebral oxygenation and blood pressure in patients undergoing hypotensive epidural anesthesia has not been completely elucidated. Previous publications have demonstrated a low incidence of post-op cognitive dysfunction in patients undergoing hypotensive epidural anesthesia for total hip replacement (1-3) and that cerebral blood flow velocity is preserved as measured by transcranial Doppler (4). An earlier investigation by Dr. Yadeau demonstrated infrequent cerebral oxygen desaturation in spontaneously breathing patients undergoing shoulder arthroscopy, even in the presence of hypotension (4), but did not investigate outcomes in the cognitive domain or have a control group of patients undergoing surgery with general anesthesia. There has only been one study looking at cerebral oxygenation and hip surgery, which was performed in elderly patients with fractures. It demonstrated that patients with low pre-op regional cerebral oxygen saturation (rSO2) had higher incidence of delirium (5) but many of those patients had surgery under general anesthesia. Given the costs associated with post-op delirium, cognitive dysfunction and stroke (6) and based on the fact that previous publications from this institution have demonstrated both a low incidence of cognitive dysfunction and preservation of cerebral blood flow velocity using this anesthetic technique, we hypothesized that cerebral oxygen desaturation will not occur in this population.
Interventions
DEVICECerebral Oximeter
Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients 18-80 years old undergoing unilateral total hip arthroplasty * Hypotensive epidural anesthesia
Exclusion criteria
* Contraindication to controlled hypotension and/or neuraxial anesthesia. * Severe pulmonary hypertension or pre-op systolic blood pressure reading \>150 mm Hg * Moderate to severe valvular stenosis. * History of stroke, dementia, or post-op delirium * Prior OSA diagnosis * History of benzodiazepine use (regular use for longer than 3 months) * Chronic renal or hepatic disease (renal failure, history of liver failure, cirrhosis) * History of alcoholism or heavy alcohol intake (defined as averaging more than 3 drinks per night; recovery is OK) * Parkinson's disease * Severe chronic pulmonary disease * Total anterior hip approach being used * Hip resurfacing procedure * Non-English Speaking\* * Questionnaires being used to assess mental status are only validated in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Desaturation Incidences | Intra-operation (when the patient enters the operating room, up to 4 hours) | The number of participant's experiencing an intra-operative cerebral oxygen desaturation event. Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Oxygen Desaturation | Intra-op ( during the time the patient is in the operating room, up to 4 hours) | Duration of cerebral oxygen desaturation |
| Presence of Post-operative Delirium | Post-op Day 1, Post-op Day 2 | The number of patients who have post-operative delirium, as determined by counting the patients who suffer from this condition. Although recorded at various time points, the total number of participants experiencing post-operative delirium was summed and reported. |
| Patients With Cognitive Dysfunction | Post-op Day 1, Post-op Day 2 | The number of patients considered to experience cognitive dysfunction as identified by low scores on the mini-Cog. The Mini-Cog checks for the brain function (or the cognitive impairment) of the participant. The Mini-Cog does this by examining a patient's ability in two areas. This is done via a three-word recall test and the Clock Drawing Test. 1. Three-Word Recall 2. The Clock Drawing Test (CDT) There are five total points a person can score on the Mini-Cog: * Give one point for each word that was correctly remembered. (0-3 points) * Give two points for a correctly drawn clock, meaning the numbers are in roughly the correct locations and two hands are pointed to the 11 and the 2. The length of the hands does not matter. (0 or 2 points) If a patient scores less than three points, they are counted as experiencing cognitive dysfunction. Although collected across different time points, the total number of patients scoring less than 3 points were summed and reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| THA Patients Patients undergoing unilateral total hip arthroplasty
Cerebral Oximeter: Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events. | 99 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | THA Patients |
|---|---|
| Age, Continuous | 60.6 years STANDARD_DEVIATION 9.9 |
| Body Mass Index | 28.2 kg/m^2 STANDARD_DEVIATION 5.4 |
| Race/Ethnicity, Customized Race Categories Black or African American | 4 Participants |
| Race/Ethnicity, Customized Race Categories Unknown | 9 Participants |
| Race/Ethnicity, Customized Race Categories White | 86 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 99 |
| other Total, other adverse events | 0 / 99 |
| serious Total, serious adverse events | 0 / 99 |
Outcome results
Primary
Oxygen Desaturation Incidences
The number of participant's experiencing an intra-operative cerebral oxygen desaturation event. Measured in the number of patients, beginning with the time the patients' enters the operating room and up to 4 hours.
Time frame: Intra-operation (when the patient enters the operating room, up to 4 hours)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THA Patients | Oxygen Desaturation Incidences | 4 Participants |
Secondary
Duration of Oxygen Desaturation
Duration of cerebral oxygen desaturation
Time frame: Intra-op ( during the time the patient is in the operating room, up to 4 hours)
Population: only 4 patients had desaturation events
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| THA Patients | Duration of Oxygen Desaturation | 11 seconds |
Secondary
Patients With Cognitive Dysfunction
The number of patients considered to experience cognitive dysfunction as identified by low scores on the mini-Cog. The Mini-Cog checks for the brain function (or the cognitive impairment) of the participant. The Mini-Cog does this by examining a patient's ability in two areas. This is done via a three-word recall test and the Clock Drawing Test. 1. Three-Word Recall 2. The Clock Drawing Test (CDT) There are five total points a person can score on the Mini-Cog: * Give one point for each word that was correctly remembered. (0-3 points) * Give two points for a correctly drawn clock, meaning the numbers are in roughly the correct locations and two hands are pointed to the 11 and the 2. The length of the hands does not matter. (0 or 2 points) If a patient scores less than three points, they are counted as experiencing cognitive dysfunction. Although collected across different time points, the total number of patients scoring less than 3 points were summed and reported.
Time frame: Post-op Day 1, Post-op Day 2
Population: From baseline to POD 1, 7 patients had positive scores in Mini-Cog Test. On POD 2, one patient withdrew from the study, so 6 patients reported positive scores in Mini-Cog test.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| THA Patients | Patients With Cognitive Dysfunction | Post-Operative Day 1 | Abnormal Clock Drawing From baseline | 3 Participants |
| THA Patients | Patients With Cognitive Dysfunction | Post-Operative Day 1 | Word Recall decrease From baseline | 4 Participants |
| THA Patients | Patients With Cognitive Dysfunction | Post-Operative Day 2 | Abnormal Clock Drawing From baseline | 3 Participants |
| THA Patients | Patients With Cognitive Dysfunction | Post-Operative Day 2 | Word Recall decrease From baseline | 3 Participants |
Secondary
Presence of Post-operative Delirium
The number of patients who have post-operative delirium, as determined by counting the patients who suffer from this condition. Although recorded at various time points, the total number of participants experiencing post-operative delirium was summed and reported.
Time frame: Post-op Day 1, Post-op Day 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| THA Patients | Presence of Post-operative Delirium | 0 Participants |