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Dexmedetomidine for Cancer Surgery Outcomes

Phase 2 & 3
Waitlist Available
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Expected stay 5 days or greater in hospital
Presenting for HIPEC with Colon or Appendix Cancer
Must not have
Current use of steroid or immunosuppressive medication
Mesothelioma tumour origin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is looking at whether a commonly used sedative could help to decrease inflammation and improve outcomes for cancer patients undergoing surgery.

Who is the study for?
This trial is for adults over 18 with colon or appendix cancer, scheduled for HIPEC at Vancouver General Hospital, and expected to stay in the hospital for at least 5 days. It's not for pregnant individuals, those with significant liver disease, current heavy opioid users, people on steroids or immunosuppressants, mesothelioma patients, anyone allergic to dexmedetomidine or with severe systemic disease.
What is being tested?
The study tests if dexmedetomidine can reduce inflammation during HIPEC surgery. Of the 20 participants undergoing this procedure as part of their cancer treatment, half will receive standard anesthesia plus a placebo saline infusion; the other half will get standard anesthesia plus dexmedetomidine. Inflammation levels are measured through blood markers before and after surgery.
What are the potential side effects?
Dexmedetomidine may cause side effects such as low blood pressure, slow heart rate, dry mouth and nausea. As it's used under controlled conditions during surgery where patients are closely monitored by anesthesiologists these risks are minimized.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I will be in the hospital for 5 days or more.
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I am undergoing HIPEC for colon or appendix cancer.
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I am 18 years old or older.
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I am having HIPEC treatment for cancer at Vancouver General Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking steroids or immunosuppressive medication.
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My cancer originates from the mesothelium.
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I have a serious liver condition.
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I am currently taking clonidine.
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I take more than 30mg of pain medication equivalent to morphine daily.
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I am allergic or sensitive to dexmedetomidine.
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I am not eligible for or have refused a thoracic epidural.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Inflammation
Secondary study objectives
Anesthesia Dose
Cancer recurrance
Opioid use

Side effects data

From 2020 Phase 4 trial • 798 Patients • NCT02004613
57%
Clinically important hypotension
9%
Clinically important bradycardia
1%
infection
1%
stroke
1%
Atelectasis
1%
Hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Dexmedetomidine

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention groupExperimental Treatment1 Intervention
Dexmedetomidine will be infused as per the protocol
Group II: PlaceboPlacebo Group1 Intervention
Normal Saline will be infused as per the protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexmedetomidine
FDA approved

Find a Location

Who is running the clinical trial?

University of British ColumbiaLead Sponsor
1,466 Previous Clinical Trials
2,485,436 Total Patients Enrolled

Media Library

Dexmedetomidine Clinical Trial Eligibility Overview. Trial Name: NCT04106999 — Phase 2 & 3
Cancer Research Study Groups: Intervention group, Placebo
Cancer Clinical Trial 2023: Dexmedetomidine Highlights & Side Effects. Trial Name: NCT04106999 — Phase 2 & 3
Dexmedetomidine 2023 Treatment Timeline for Medical Study. Trial Name: NCT04106999 — Phase 2 & 3
~7 spots leftby Nov 2025
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