High Spinal Anesthesia and the Incidence of Delirium After Cardiac Surgery: a Randomized-controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Protocol adherence measure - establishment of spinal anesthetic
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (>18 years old) patients
- •Undergoing elective or urgent cardiac surgical procedures with cardiopulmonary bypass
排除标准
- •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
研究组 & 干预措施
High spinal anesthesia
- 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.
干预措施: Intrathecal bupivacaine and morphine (Drug)
结局指标
主要结局
Protocol adherence measure - establishment of spinal anesthetic
时间窗: 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
时间窗: 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.
Recruitment rate
时间窗: One year
Mean number of patients recruited per week) (n)
次要结局
- Verification of early incidence of post-operative delirium(Day of surgery until five days post-operatively)
- Early incidence of post-operative delirium(Day of surgery until five days post-operatively)
- Late incidence of post-operative delirium(Post-operative day 6 until post-operative day 14 or discharge from hospital whichever occurs first.)
- Use of risperidone post-operatively(Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.)
- Use of dexmedetomidine post-operatively(Day of surgery until post-operative day 5 or discharge from the intensive care unit whichever comes first..)
- Use of haloperidol post-operatively(Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.)
- Use of quetiapine post-operatively(Day of surgery until post-operative day 14 or discharge from hospital, whichever occurs first.)
- Verification of late incidence of post-operative delirium(Post-operative day 6 until post-operative day 14 or discharge from hospital, whichever occurs first.)