Postoperative Delirium After Total Knee Arthroplasty Under Regional Anesthesia: a Comparison Between Intraoperative Sedation With Fentanyl, Fentanyl-dexmedetomidine and Fentanyl-propofol
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of postoperative delirium
研究概览
简要总结
Postoperative delirium after total knee replacement surgery has been related to significant morbidity and mortality among high risk patients. Anesthetic care might play a role in the development of postoperative delirium.
The purpose of this study is to compare the incidence of postoperative delirium between different intraoperative sedation regimen. Delirium assessment using standardized screening tools will be done every 8 hours after surgery.
详细描述
- In this randomized controlled trial, the investigator will compare the incidence of postoperative delirium after total knee arthroplasty between 3 intraoperative sedation regimens including (1) propofol-fentanyl (2) dexmedetomidine -fentanyl (3) fentanyl alone
- Anesthesia techniques include spinal anesthesia and adductor canal block for postoperative analgesia. Sedation will be provide per group assignment.
- After performance of regional anesthesia, sedation protocols will be used as followed: (1) target-controlled infusion of Propofol to achieve MOAA/S of 3-4 (2) incremental titration of Dexmedetomidine to achieve MOAA/S of 3-4 (3) supplemental fentanyl for anxiolysis.
- Delirium will be screened by trained physicians, registered nurses every 8 hours postoperatively with validated Thai-version CAM-ICU (Confusion Assessment Method-Intensive Care Unit) until patient discharge.
- Serum Interleukins (IL-1, IL-6) Tumor necrosis factor-Alpha and S100B protein from preoperative period will be compared with serum from postoperative period between delirium and non-delirium group. The level of serum biomarkers will be acquired in a 6-hour interval for 5 measurement points during the first postoperative day in the first 12 participants. The subsequent participants will have 1 measurement of serum biomarker during the first postoperative day.
- Genetic profile for ApolipoproteinE genotype will be acquired and compared between delirium and non-delirium group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 year or older
- •Scheduled for elective primary total knee arthroplasty
排除标准
- •Contraindication for spinal anesthesia
- •Contraindication for adductor canal block
- •Allergy to fentanyl or propofol or dexmedetomidine or bupivacaine
- •Cognitive impairment
- •NSQIP database risk calculator > 10% overall complication
- •Unable to communicate in Thai language
- •Significant visual and hearing impairment
研究组 & 干预措施
Propofol-fentanyl
Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring
干预措施: Propofol (Drug)
Propofol-fentanyl
Fentanyl 0.5 mcg/kg Propofol Target-controlled infusion to achieve MOAA/S 3-4 as end point of sedation Bispectral index (BIS) monitoring
干预措施: Fentanyl (Drug)
Dexmedetomidine
Fentanyl 0.5 mcg/kg Dexmedetomidine in incremental titrated dose for moderate sedation to achieve MOAA/S 3-4 as end-point of titration Bispectral index (BIS) monitoring
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine
Fentanyl 0.5 mcg/kg Dexmedetomidine in incremental titrated dose for moderate sedation to achieve MOAA/S 3-4 as end-point of titration Bispectral index (BIS) monitoring
干预措施: Fentanyl (Drug)
Fentanyl
Fentanyl 0.5 mcg/kg Supplemental dosage of fentanyl for intraoperative anxiolysis
干预措施: Fentanyl (Drug)
结局指标
主要结局
Incidence of postoperative delirium
时间窗: Up to 7 days
Positive CAM-ICU result and confirmed DSM-V criteria for delirium
次要结局
- The effect of age on the incidence of postoperative delirium(Up to 7 days)
- Inflammatory biomarker(2 days)
- The effect of ASA-physical status on the incidence of postoperative delirium(Up to 7 days)
- The effect of cerebrovascular disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of liver disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of intraoperative blood transfusion and blood loss on the incidence of postoperative delirium(7 days)
- The effect of delirium on postoperative complications.(7 days)
- The effect of Apolipoprotein genotype on the incidence of postoperative delirium(Up to 7 days)
- The effect of delirium on inflammatory biomarker levels(Up to 7 days)
- The effect of chronic kidney disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of postoperative pain on the incidence of postoperative delirium(Up to 7 days)
- The effect of delirium on hospital length of stay(7 days)
- Apolipoprotein genotype(1 days)
- The effect of alcohol consumption on the incidence of postoperative delirium(Up to 7 days)
- The effect of cognitive inpairment on the incidence of postoperative delirium(Up to 7 days)
- The effect of coronary artery disease on the incidence of postoperative delirium(Up to 7 days)
- The effect of diabetes mellitus on the incidence of postoperative delirium(Up to 7 days)
- The effect of gender on the incidence of postoperative delirium(Up to 7 days)
- The effect of delirium on postoperative rehabilitation(7 days)
- The effect of hypertension on the incidence of postoperative delirium(Up to 7 days)
- The effect of intraoperative BIS value on the incidence of postoperative delirium(7 days)
研究者
patcharee sriswasdi
MD, MPH
Mahidol University