Pilot Study Comparing Treatment With Dexmedetomidine to Midazolam for Symptom Control in Advanced Cancer Patients

• Status: Withdrawn
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fraser Health
• Treatments: Dexmedetomidine; Midazolam

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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