Dexmedetomidine Compared to Midazolam for Symptom Control in Advanced Cancer Patients: A Pilot Randomized Controlled Trial (RCT)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Number of subjects needed to recruit for a multicenter double blind randomized controlled phase III trial comparing dexmedetomidine to midazolam for symptom control in advanced cancer patients
研究概览
简要总结
Cancer patients with very difficult to control symptoms at the Abbotsford (AC) and Fraser Valley (FVC) Cancer Centers are referred and admitted to the Tertiary Palliative Care Units at the Abbotsford Regional Hospital and Cancer Center(ARHCC). For symptom management, patients are sometimes given midazolam continuously through a needle placed underneath the skin. While effective in symptom management, midazolam can be sedating, leaving patients unable to interact with loved ones in their last days.
This study is a pilot project. Before proceeding to a full-scale study, a "pilot study" or "feasibility study" is often carried out first to test the design of a study, the likelihood of successful recruitment or the acceptability of the intervention to potential subjects. The basic idea is to find out whether it will be practical to proceed to a larger study that will include more subjects. This type of study involves only a small number of subjects and therefore the results can only be used as a guide for further larger studies.
The investigators also will determine whether palliative care cancer patients taking a medication called dexmedetomidine would have improved rousability (more easily and fully awakened) and symptom control (pain, shortness of breath, nausea or confusion) compared with those taking standard of care which is receiving the medication midazolam. The use of dexmedetomidine in other clinical situations (in the Operating Room or Intensive Care Unit where the patient can still respond to the doctor) has been shown to be effective in symptom control and to provide a better degree of rousability to patients but has not been well studied in the palliative care environment.
详细描述
INTRODUCTION AND BACKGROUND
Advanced cancer patients nearing the end of life suffer from pain, anxiety and other symptoms that can be very difficult to control. The current practice within Fraser Health Authority is to admit these patients to one of three tertiary palliative care units (TPCUs) for pain and symptom management. Once admitted, if pain and symptom relieving measures are insufficient, patients are given a continuous subcutaneous infusion (CSCI) of the drug midazolam for symptom management. While effective, sedation with midazolam often leaves patients unable to eat or drink or interact with their environment.
Dexmedetomidine is a unique and promising agent for managing intractable symptoms in palliative patients at the end of life . In addition to providing proportional sedation for symptom control, compared to midazolam, dexmedetomidine has the additional attributes of providing improved management of pain, dyspnea and delirium. Of special interest to patients who would like to continue to be involved in decision making and to be able to communicate with loved ones at the end of life is the quality of rousability possible when dexmedetomidine is used for sedation instead of midazolam. These features have been well studied in the ICU and anaesthesia literature but not in the palliative care environment.
PURPOSE AND JUSTIFICATION
Currently, standard care for patients with difficult or intractable symptoms for patients admitted to the tertiary palliative care units in Fraser Health is the administration of midazolam by CSCI as recommended in the evidence based Fraser Health Authority (FHA) Hospice Palliative Care Program Symptom Guideline "Refractory Symptoms and Palliative Sedation Therapy Guideline". The same guideline states that among the criteria for implementation of palliative sedation therapy is that "in all but the most unusual circumstances, death is anticipated within hours to days". However, many other patients with difficult or intractable symptoms have a natural course of their illness that is longer than 'hours to days'. These patients would benefit from a degree of sedation that is proportional to the severity of their symptoms. Therefore, particularly in these circumstances, an option other than deep palliative sedation with midazolam is necessary where the patient would very often like to be aware of those around them and still not be confused or in pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater or equal to 19 years of age
- •Advanced cancer patient admitted to the Abbotsford Tertiary Palliative Care Unit
- •Difficult to control or intractable symptom (REF 38, page 3)
- •Midazolam CSCI would normally be considered for symptom management
- •Informed consent is able to be provided in the English language
- •Goals of care include do not resuscitate (DNR)
- •For intractable symptoms, patient would prefer proportional sedation rather than no sedation or total sedation.
排除标准
- •Second or third degree heart block (without pacemaker)
- •Uncompensated congestive heart failure
- •Heart rate less than 50 beats per minute
- •Mean arterial blood pressure (MAP) < 60
- •Weight below 35 kg. or above 85 kg.
- •Prior use within the preceding 14 days of high dose benzodiazepines equivalent to the use of 30 mg or more of midazolam or 6 mg or more of lorazepam per 24 hours.
- •Currently enrolled in any other research study involving drugs or devices
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine 0.2 to 1.1 mcg/kg/hr by continuous subcutaneous infusion for up to 10 days
干预措施: Dexmedetomidine (Drug)
Midazolam
Midazolam 10 to 100 mcg/kg/hr by continuous subcutaneous infusion for up to 10 days
干预措施: Midazolam (Drug)
结局指标
主要结局
Number of subjects needed to recruit for a multicenter double blind randomized controlled phase III trial comparing dexmedetomidine to midazolam for symptom control in advanced cancer patients
时间窗: one year
Sample size determination for significant improvement in: * Pain * Dyspnea * Nausea * Delirium * Rousability
次要结局
- Change in pain (0 to 10 numerical scale)(Up to 10 days)
- Change in delirium (16 item clinician rated scale)(Up to 10 days)
- Change in dyspnea (0 to 10 numerical scale)(Up to 10 days)
- Change in nausea (0 to 10 numerical scale)(Up to 10 days)
- Rousability (10 point scale)(Up to 10 days)
- Acceptable symptom control (yes/no)(Up to 10 days)