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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 days
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Inflammation
Secondary outcome measures
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

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
1,415 Previous Clinical Trials
2,466,996 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other ongoing investigations into Dexmedetomidine's effects?

"There are currently 119 studies being conducted on Dexmedetomidine. Out of those, 25 are Phase 3 clinical trials. The largest concentration of these trials is in Karachi, Sindh. However, there are a total of 221 research sites for this medication."

Answered by AI

What is Dexmedetomidine used to treat?

"Dexmedetomidine is regularly used to treat patients with different diseases. Additionally, it can be used as a medication for ventilations, cyclic vomiting syndrome, and intubations."

Answered by AI

Are people aged 55 and older being asked to participate in this trial?

"This clinical trial is only for patients aged 18-99. If you are looking for studies involving minors or senior citizens, there are 123 and 789 trials respectively."

Answered by AI

For what type of patients is this trial meant?

"Up to 20 cancer patients, aged 18 to 99, who will be receiving Hyperthermic Intraperitoneal Chemotherapy (HIPEC) as part of their cancer treatment at Vancouver General Hospital are welcome to participate in this study. To be eligible, patients must be 18 years of age or older and expected to spend 5 or more days in the hospital."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Dexmedetomidine and HIPEC
Jason Wilson 2023. "Dexmedetomidine and HIPEC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04106999.
~1 spots leftby Jun 2024
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