Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a feasibility study to determine if enough patients undergoing elective or urgent cardiac surgery, can be enrolled in a study where patients are randomized to receive high spinal anesthesia as an adjunct to general anesthesia for their cardiac surgery. The primary clinical outcome will be the incidence of post-operative delirium.
Intervention
Patients will be randomized to either general anesthesia (GA) or HSA + GA.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High spinal anesthesia | Active Comparator |
|
|
| Control group | No Intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrathecal bupivacaine and morphine | Drug | Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Mean number of patients recruited per week) (n) | One year |
| Protocol adherence measure - establishment of spinal anesthetic | In order to assess protocol adherence (%), in patients randomized to spinal anesthesia, an 80% success rate in establishing a spinal anesthetic will be considered as protocol adherence. | Day of surgery |
| Protocol adherence measure - completion of delirium assessments | In order to assess protocol adherence (%), completion of 90% of scheduled delirium assessments will be considered protocol adherence. | Day of surgery until five days post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Early incidence of post-operative delirium | Duration of delirium (days) as assessed by the number of positive Confusion Assessment Method (CAM) as assessed by study investigator | Day of surgery until five days post-operatively |
| Verification of early incidence of post-operative delirium |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intraoperative extubation | Incidence of extubation in the operating room (%) | Day of surgery |
| Duration of ICU intubation | Duration of ICU intubation in hours for those patients brought intubated to the ICU |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doug Maguire, MD | University of Manitoba | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2A6 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009020 | Morphine |
| D002045 | Bupivacaine |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
Not provided
Not provided
Patients will be randomized to either general anesthesia (GA) or HSA + GA.
Not provided
Not provided
All patients will be assessed by the study investigator for presence/absence of delirium on postoperative days 1,2 & 3, as well as routine nursing assessment by the delirium assessment tool CAM-ICU, routinely done by nursing staff. Chart reviews will be conducted to confirm any additional incidence of delirium. The data collectors will not be aware whether the patient had a spinal anesthetic or not.
|
Duration of delirium (days) as assessed by the number of positive CAM Scores as assessed by nursing/physicians (by chart review). |
| Day of surgery until five days post-operatively |
| Late incidence of post-operative delirium | Duration of delirium (days) as assessed by the number of positive CAM scores as assessed by study investigator from post-operative day 6 to post-operative day 14 or discharge from hospital | Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first. |
| Verification of late incidence of post-operative delirium | Duration of delirium (days) as assessed by the number of positive CAM scores as assessed by nursing/physicians (by chart review) from post-operative day 6 to discharge from hospital | Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first. |
| Use of haloperidol post-operatively | Incidence (%) and total dose of haloperidol, in milligrams, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from hospital | Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. |
| Use of quetiapine post-operatively | Incidence (%) and total dose of quetiapine, in milligrams, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from hospital. | Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. |
| Use of risperidone post-operatively | Incidence (%) and total dose of risperidone, in milligrams, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from hospital. | Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. |
| Use of dexmedetomidine post-operatively | Incidence (%) of use of dexmedetomidine infusions, for treatment of agitation as ordered by attending medical staff from day of surgery to discharge from the intensive care unit. | Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first.. |
| Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. |
| Post-operative pain scores at rest | VAS pain scores (visual analog score) (0 is no pain, 10 is the worst pain possible) at rest for 3 days post-operatively. | Post-operative day 1 until post-operative day 3 |
| Post-operative pain scores with deep breathing | VAS pain scores (0 is no pain, 10 is the worst pain possible) with deep breathing for 3 days post-operatively. | Post-operative day 1 until post-operative day 3 |
| Post-operative hydromorphone administered | Total hydromorphone use including intravenous and oral administration will be recorded for the first 48 hours postoperatively. Hydromorphone totals will be converted to morphine equivalents using MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator). | Day of surgery until post-operative day 3 |
| Post-operative fentanyl administered | Total fentanyl use including intravenous and oral administration will be recorded for the first 48 hours postoperatively. Fentanyl totals will be converted to morphine equivalents using MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator). | Day of surgery until post-operative day 3 |
| Post-operative codeine administered | Total codeine use including intravenous and oral administration will be recorded for the first 48 hours postoperatively. Codeine totals will be converted to morphine equivalents using MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator). | Day of surgery until post-operative day 3 |
| Post-operative morphine administered | Total morphine use, in milligrams, including intravenous and oral administration will be recorded for the first 48 hours postoperatively. | Day of surgery until post-operative day 3 |
| Intraoperative hypotension | Length of time (mins) mean arterial blood pressure is less than 55 mmHg | Day of surgery |
| Intraoperative end-tidal gas concentration | Mean intraoperative end-tidal gas concentration (%) | Day of surgery |
| Intraoperative depth of anesthesia | Mean intraoperative bispectral index (BIS). The BIS scale range is from 0 to 100, with 0 representing no measurable electrical brain activity and 100 the electrical activity of an awake, conscious individual. Currently BIS scores are attempted to be kept between 20 and 40 during surgery to ensure adequate depth of anesthesia. | Day of surgery |
| Intraoperative sufentanil administered | Total dose of intraoperative sufentanil in micrograms. Sufentanil dosage will be converted to morphine equivalents using the MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator) | Day of surgery |
| Intraoperative hydromorphone administered | Total dose of intraoperative hydromorphone in milligrams. Hydromorphone doses will be converted to morphine equivalents using the MD Calcs algorithm (https://www.mdcalc.com/morphine-milligram-equivalents-mme-calculator) | Day of surgery |
| Intraoperative midazolam administered | Total dose of intraoperative midazolam in milligrams. | Day of surgery |
| Intraoperative ketamine administered | Total dose of intraoperative ketamine in milligrams | Day of surgery |
| Intraoperative glucose level | Highest intraoperative glucose level in millimoles per litre. | Day of surgery |
| Intraoperative insulin administered | Total intraoperative insulin administered in units of insulin. | Day of surgery |
| Total RBC utilization | Total RBC administered (units) both intraoperatively, and postoperatively until post-operative day 3.. | Day of surgery until post-operative day 3 |
| Total platelet utilization | Total units of platelets administered (adult doses of platelets ) both intraoperatively, and postoperatively until post-operative day 3 | Day of surgery until post-operative day 3 |
| Return to OR for bleeding | Incidence of a return to the operating room for bleeding (%) | Day of surgery until post-operative day 3 |
| Vasopressor (norepinephrine or phenylephrine or vasopressin) use at 12 hours | Incidence of use of either norepinephrine, phenylephrine or vasopressin at 12 hours postoperatively (%) | First 12 hours postoperatively |
| Vasopressor (norepinephrine, phenylephrine or vasopressin) use at 24 hours | Incidence of use of norepinephrine, phenylephrine or vasopressin administered at 24 hours postoperatively (%) | 12 to 24 hours postoperatively |
| Vasopressor (norepinephrine, phenylephrine or vasopressin) use at >24 hours | Incidence of norepinephrine, phenylephrine or vasopressin use longer than 24 hours postoperatively (%) | Post-operative day 2 to post-operative day 7 |
| Incidence of re-intubation | Incidence of re-intubation postoperatively (%) from day of surgery to discharge from hospital | Day of surgery until 14 days post-operatively or discharge from hospital, whichever occurs first. |
| ICU re-admission | Incidence of re-admission to ICU for any reason from post-operative day 2 to post-operative day 14 or discharge from hospital (%) | Post-operative day 2 until post-operative day 14 or discharge from hospital, whichever occurs first. |
| Hospital length of stay | Postoperative hospital length of stay in days | Time (days) in hospital from post-operative 1 to 30 (or through discharge from hospital) |
| ICU length of stay | Postoperative ICU length of stay in days | Time (days) in ICU from post-operative day 1 to 5 (or through discharge from hospital) |
| Major medical complications | Incidence of major medical complications (%) defined as one or more of: a. Atrial fibrillation b. Pneumonia c. Acute kidney injury (defined as a doubling of pre-operative creatinine) d. Need for dialysis e. Wound infection f. Stroke g. Other | Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first. |
| Post-operative quality of recovery - one month | Postoperative quality of life score (Postop QoR-15) will be used to assess quality of recovery at one month postoperatively. The Post QoR-15 scale ranges from 0 to 150, with 0 representing the poorest quality of recovery and 150 the best quality of recovery. | 30 days post surgery |
| Post-operative quality of recovery - three months | Postoperative quality of life score (Postop QoR-15) will be used to assess quality of recovery at three month postoperatively. The Post QoR-15 scale ranges from 0 to 150, with 0 representing the poorest quality of recovery and 150 the best quality of recovery. | 90 days post surgery |
| Post-operative creatinine level | Highest post-operative creatinine (umol/l) level recorded during hospital stay. | Day of surgery until 14 days post-operatively or hospital discharge, whichever occurs first. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |