Post-Operative ConfusionNCT05374356
High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery
A study testing Intrathecal bupivacaine and morphine in people with Post-Operative Confusion, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Operative Confusion
- What is being tested?
- Intrathecal bupivacaine and morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 2 May 2022to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years old) patients
- Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery: a Randomized-controlled Feasibility Trial
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.
Read the 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.
- Conditions
- Post-Operative Confusion
- Being tested
- Intrathecal bupivacaine and morphine
- Keywords
- Cardiac surgery, Delirium, Spinal anesthesia
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal bupivacaine and morphineDrug
Also called Drug: bupivacaine 0.75% in dextrose (0.3 to 0.6 mls/kg), Drug: preservative free morphine 3 mcg/kg
Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).
| Study group | Role | What they receive |
|---|---|---|
| High spinal anesthesia | Active comparator | 1. Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg).
2. 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.
3. 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. Receives: Drug: Intrathecal bupivacaine and morphine |
| Control group | No intervention | 1. 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. 2. 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Mean number of patients recruited per week) (n)
Measured: 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.
Measured: 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.
Measured: Day of surgery until five days post-operatively
Secondary outcomes (8)
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
Measured: Day of surgery until five days post-operatively
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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2022
- Study start2 May 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative ConfusionStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either general anesthesia (GA) or HSA + GA.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doug Maguire, MD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05374356
- Sponsor's protocol ID
- HS23755 B2020:026
- Status last verified
- Jun 2023
- First submitted
- 13 Apr 2022
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery: a Randomized-controlled Feasibility Trial
- ClinicalTrials.gov ID
- NCT05374356
- Acronym / sponsor ID
- HS23755 B2020:026
- Conditions
- Post-Operative Confusion
- Keywords
- Cardiac surgery, Delirium, Spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to either general anesthesia (GA) or HSA + GA.
| Arm | Type | Receives |
|---|---|---|
| High spinal anesthesia | Active comparator | Drug: Intrathecal bupivacaine and morphine1. Spinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). 2. 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. 3. 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. |
| Control group | No intervention | –1. 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. 2. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (>18 years old) patients
- Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal bupivacaine and morphineAlso: Drug: bupivacaine 0.75% in dextrose (0.3 to 0.6 mls/kg), Drug: preservative free morphine 3 mcg/kgSpinal group: will receive high spinal anesthesia with hyperbaric bupivacaine (0.3 to 0.6 mgs/kg) + preservative free morphine (3 mcg/kg). | Drug | High spinal anesthesia |
Primary outcome
Recruitment rate
Time frame: One year
Mean number of patients recruited per week) (n)
Protocol adherence measure - establishment of spinal anesthetic
Time frame: Day of surgery
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
Time frame: Day of surgery until five days post-operatively
In order to assess protocol adherence (%), completion of 90% of scheduled delirium assessments will be considered protocol adherence.
8 secondary outcomes
Early incidence of post-operative delirium
Time frame: Day of surgery until five days post-operatively
Verification of early incidence of post-operative delirium
Time frame: Day of surgery until five days post-operatively
Late incidence of post-operative delirium
Time frame: Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first.
Verification of late incidence of post-operative delirium
Time frame: Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first.
Use of haloperidol post-operatively
Time frame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Use of quetiapine post-operatively
Time frame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Use of risperidone post-operatively
Time frame: Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.
Use of dexmedetomidine post-operatively
Time frame: Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first..
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Post-Operative Confusion
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doug Maguire, MD study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal bupivacaine and morphine in people with Post-Operative Confusion, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.