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High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

Primary Purpose

Post-Operative Confusion

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Intrathecal bupivacaine and morphine
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Operative Confusion focused on measuring Cardiac surgery, Delirium, Spinal anesthesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult (>18 years old) patients
  • Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass

Exclusion Criteria:

  • Contraindications to spinal anesthesia such as active anticoagulation, clopidogrel within 7 days of surgery, ticagrelor within 3 days of surgery and all other contraindications to lumbar puncture
  • Pre-existing psychiatric diagnoses such as schizophrenia or manic-depressive disorder
  • Complex aortic surgery (> hemi-arch repair, descending thoracic surgery)
  • Difficult airway requiring an awake intubation
  • BMI > 50

Sites / Locations

  • St. Boniface HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

High spinal anesthesia

Control group

Arm Description

Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). Standard intraoperative monitors will include ECG, pulse oximetry, end-tidal CO2 and anesthetic gas measurement, quantitative EEG monitoring (BIS monitor), arterial line, central venous pressure line and any other monitor as clinically indicated. Conduct of the general anesthetic will not be protocolized. It will be a pragmatic study. The attending anesthesiologist will attempt to have a BIS score of 20- 40 during the operation.

Standard intraoperative monitors will include ECG, pulse oximetry, end-tidal CO2 and anesthetic gas measurement, quantitative EEG monitoring (BIS monitor), arterial line, central venous pressure line and any other monitor as clinically indicated. Conduct of the general anesthetic will not be protocolized. It will be a pragmatic study. The attending anesthesiologist will attempt to have a BIS score of 20- 40 during the operation.

Outcomes

Primary Outcome Measures

Recruitment rate
Mean number of patients recruited per week) (n)
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.
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.

Secondary Outcome Measures

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
Verification of early 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).
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
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
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
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.
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.
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.

Full Information

First Posted
April 13, 2022
Last Updated
May 9, 2022
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT05374356
Brief Title
High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery
Official Title
High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery: a Randomized-controlled Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Intervention Patients will be randomized to either general anesthesia (GA) or HSA + GA. Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). Standard intraoperative monitors will include ECG, pulse oximetry, end-tidal CO2 and anesthetic gas measurement, quantitative EEG monitoring (BIS monitor), arterial line, central venous pressure line and any other monitor as clinically indicated. Conduct of the general anesthetic will not be protocolized. It will be a pragmatic study. The attending anesthesiologist will attempt to have a BIS score of 20- 40 during the operation. Intraoperative physiological data (mean blood pressure, end-tidal anesthetic gas concentrations, BIS score) will be recorded and downloaded to a laptop computer using the Trend Face Solo acquisition system for subsequent analysis. The routine postoperative care map for the postoperative cardiac intensive care unit (ICCS) will be followed. 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. All patients will be contacted at one and three months after surgery and asked to complete a ten-minute survey (Postop QoR-15 questionnaire) assessing their quality of recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Confusion
Keywords
Cardiac surgery, Delirium, Spinal anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized to either general anesthesia (GA) or HSA + GA.
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High spinal anesthesia
Arm Type
Active Comparator
Arm Description
Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). Standard intraoperative monitors will include ECG, pulse oximetry, end-tidal CO2 and anesthetic gas measurement, quantitative EEG monitoring (BIS monitor), arterial line, central venous pressure line and any other monitor as clinically indicated. Conduct of the general anesthetic will not be protocolized. It will be a pragmatic study. The attending anesthesiologist will attempt to have a BIS score of 20- 40 during the operation.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard intraoperative monitors will include ECG, pulse oximetry, end-tidal CO2 and anesthetic gas measurement, quantitative EEG monitoring (BIS monitor), arterial line, central venous pressure line and any other monitor as clinically indicated. Conduct of the general anesthetic will not be protocolized. It will be a pragmatic study. The attending anesthesiologist will attempt to have a BIS score of 20- 40 during the operation.
Intervention Type
Drug
Intervention Name(s)
Intrathecal bupivacaine and morphine
Other Intervention Name(s)
Drug: bupivacaine 0.75% in dextrose (0.3 to 0.6 mls/kg), Drug: preservative free morphine 3 mcg/kg
Intervention Description
Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).
Primary Outcome Measure Information:
Title
Recruitment rate
Description
Mean number of patients recruited per week) (n)
Time Frame
One year
Title
Protocol adherence measure - establishment of spinal anesthetic
Description
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.
Time Frame
Day of surgery
Title
Protocol adherence measure - completion of delirium assessments
Description
In order to assess protocol adherence (%), completion of 90% of scheduled delirium assessments will be considered protocol adherence.
Time Frame
Day of surgery until five days post-operatively
Secondary Outcome Measure Information:
Title
Early incidence of post-operative delirium
Description
Duration of delirium (days) as assessed by the number of positive Confusion Assessment Method (CAM) as assessed by study investigator
Time Frame
Day of surgery until five days post-operatively
Title
Verification of early incidence of post-operative delirium
Description
Duration of delirium (days) as assessed by the number of positive CAM Scores as assessed by nursing/physicians (by chart review).
Time Frame
Day of surgery until five days post-operatively
Title
Late incidence of post-operative delirium
Description
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
Time Frame
Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first.
Title
Verification of late incidence of post-operative delirium
Description
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
Time Frame
Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first.
Title
Use of haloperidol post-operatively
Description
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
Time Frame
Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Title
Use of quetiapine post-operatively
Description
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.
Time Frame
Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Title
Use of risperidone post-operatively
Description
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.
Time Frame
Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Title
Use of dexmedetomidine post-operatively
Description
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.
Time Frame
Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first..
Other Pre-specified Outcome Measures:
Title
Incidence of intraoperative extubation
Description
Incidence of extubation in the operating room (%)
Time Frame
Day of surgery
Title
Duration of ICU intubation
Description
Duration of ICU intubation in hours for those patients brought intubated to the ICU
Time Frame
Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Title
Post-operative pain scores at rest
Description
VAS pain scores (visual analog score) (0 is no pain, 10 is the worst pain possible) at rest for 3 days post-operatively.
Time Frame
Post-operative day 1 until post-operative day 3
Title
Post-operative pain scores with deep breathing
Description
VAS pain scores (0 is no pain, 10 is the worst pain possible) with deep breathing for 3 days post-operatively.
Time Frame
Post-operative day 1 until post-operative day 3
Title
Post-operative hydromorphone administered
Description
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).
Time Frame
Day of surgery until post-operative day 3
Title
Post-operative fentanyl administered
Description
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).
Time Frame
Day of surgery until post-operative day 3
Title
Post-operative codeine administered
Description
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).
Time Frame
Day of surgery until post-operative day 3
Title
Post-operative morphine administered
Description
Total morphine use, in milligrams, including intravenous and oral administration will be recorded for the first 48 hours postoperatively.
Time Frame
Day of surgery until post-operative day 3
Title
Intraoperative hypotension
Description
Length of time (mins) mean arterial blood pressure is less than 55 mmHg
Time Frame
Day of surgery
Title
Intraoperative end-tidal gas concentration
Description
Mean intraoperative end-tidal gas concentration (%)
Time Frame
Day of surgery
Title
Intraoperative depth of anesthesia
Description
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.
Time Frame
Day of surgery
Title
Intraoperative sufentanil administered
Description
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)
Time Frame
Day of surgery
Title
Intraoperative hydromorphone administered
Description
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)
Time Frame
Day of surgery
Title
Intraoperative midazolam administered
Description
Total dose of intraoperative midazolam in milligrams.
Time Frame
Day of surgery
Title
Intraoperative ketamine administered
Description
Total dose of intraoperative ketamine in milligrams
Time Frame
Day of surgery
Title
Intraoperative glucose level
Description
Highest intraoperative glucose level in millimoles per litre.
Time Frame
Day of surgery
Title
Intraoperative insulin administered
Description
Total intraoperative insulin administered in units of insulin.
Time Frame
Day of surgery
Title
Total RBC utilization
Description
Total RBC administered (units) both intraoperatively, and postoperatively until post-operative day 3..
Time Frame
Day of surgery until post-operative day 3
Title
Total platelet utilization
Description
Total units of platelets administered (adult doses of platelets ) both intraoperatively, and postoperatively until post-operative day 3
Time Frame
Day of surgery until post-operative day 3
Title
Return to OR for bleeding
Description
Incidence of a return to the operating room for bleeding (%)
Time Frame
Day of surgery until post-operative day 3
Title
Vasopressor (norepinephrine or phenylephrine or vasopressin) use at 12 hours
Description
Incidence of use of either norepinephrine, phenylephrine or vasopressin at 12 hours postoperatively (%)
Time Frame
First 12 hours postoperatively
Title
Vasopressor (norepinephrine, phenylephrine or vasopressin) use at 24 hours
Description
Incidence of use of norepinephrine, phenylephrine or vasopressin administered at 24 hours postoperatively (%)
Time Frame
12 to 24 hours postoperatively
Title
Vasopressor (norepinephrine, phenylephrine or vasopressin) use at >24 hours
Description
Incidence of norepinephrine, phenylephrine or vasopressin use longer than 24 hours postoperatively (%)
Time Frame
Post-operative day 2 to post-operative day 7
Title
Incidence of re-intubation
Description
Incidence of re-intubation postoperatively (%) from day of surgery to discharge from hospital
Time Frame
Day of surgery until 14 days post-operatively or discharge from hospital, whichever occurs first.
Title
ICU re-admission
Description
Incidence of re-admission to ICU for any reason from post-operative day 2 to post-operative day 14 or discharge from hospital (%)
Time Frame
Post-operative day 2 until post-operative day 14 or discharge from hospital, whichever occurs first.
Title
Hospital length of stay
Description
Postoperative hospital length of stay in days
Time Frame
Time (days) in hospital from post-operative 1 to 30 (or through discharge from hospital)
Title
ICU length of stay
Description
Postoperative ICU length of stay in days
Time Frame
Time (days) in ICU from post-operative day 1 to 5 (or through discharge from hospital)
Title
Major medical complications
Description
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
Time Frame
Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Title
Post-operative quality of recovery - one month
Description
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.
Time Frame
30 days post surgery
Title
Post-operative quality of recovery - three months
Description
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.
Time Frame
90 days post surgery
Title
Post-operative creatinine level
Description
Highest post-operative creatinine (umol/l) level recorded during hospital stay.
Time Frame
Day of surgery until 14 days post-operatively or hospital discharge, whichever occurs first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (>18 years old) patients Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass Exclusion Criteria: Contraindications to spinal anesthesia such as active anticoagulation, clopidogrel within 7 days of surgery, ticagrelor within 3 days of surgery and all other contraindications to lumbar puncture Pre-existing psychiatric diagnoses such as schizophrenia or manic-depressive disorder Complex aortic surgery (> hemi-arch repair, descending thoracic surgery) Difficult airway requiring an awake intubation BMI > 50
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen E Kowalski, MD
Phone
2042273626
Email
sekowalski@hsc.mb.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Girling, BScHons
Phone
2047871414
Email
lgirling@hsc.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Maguire, MD
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen E Kowalski, MD
Phone
2042273626
Email
sekowalski@hsc.mb.ca
First Name & Middle Initial & Last Name & Degree
Linda Girling, Hons Bsc
Phone
2047871414
Email
lgirling@hsc.mb.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery

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