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Dexmedetomidine and HIPEC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04106999
Recruitment Status : Not yet recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Jason Wilson, University of British Columbia

Brief Summary:
Inflammation is associated with an increased risk of cancer recurrence. Various methods have been used to decrease the inflammatory response induced by the cancer and surgery. In this study we would like determine if a commonly used sedative drug (dexmedtomidine) has an impact on this inflammatory state when used as part of the anesthetic. We will conduct a pilot study with 20 patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment. 10 patients will receive the standard of care for anesthesia during the cancer surgery and a placebo infusion of normal saline at a rate consistent to that of the study drug. 10 additional patients will receive the same standard of care anesthetic plan with the addition of an infusion of dexmeditomidine during the procedure. We will measure the degree of inflammation before, during and after the surgical procedure by looking at the levels of inflammatory markers in blood samples. The goal is to determine if the addition of dexmodtomidine affects the inflammatory state of patients undergoing a HIPEC procedure. This information will be used to guide future studies aiming at decreasing cancer recurrence and improve patient outcomes.

Condition or disease Intervention/treatment Phase
Inflammation Cancer Drug: Dexmedetomidine Drug: Placebos Phase 2 Phase 3

Detailed Description:

Purpose: To investigate the use of intra-operative dexmedetomidine infusions to reduce the inflammatory and stress response of cytoreductive treatment and hyperthermic intra-peritoneal chemotherapy (HIPEC).

Hypothesis: HIPEC surgery patients who receive an intra-operative infusion of dexmedetomidine in addition to the current standard of care, consisting of parenteral and enteral opioids and thoracic epidural will have a reduction in their inflammatory markers intra-operatively, in PACU, POD1 and POD5 and a reduction in oral morphine equivalent opioid consumption in PACU and POD1, in comparison to those who receive a placebo infusion.

Justification: Surgical tumor excision is a cornerstone of primary cancer treatment, but is also recognized as one of the greatest risk factors for metastatic spread. The perioperative period, characterized by the surgical stress response and pharmacologic-induced angiogenesis and immunomodulation, results in a physiologic environment that supports tumor spread and distant reimplantation. There is potential for anesthesiologists to modulate the unwanted consequences of the stress response on the immune system and minimize residual disease by altering their anesthetic plan.

Dexmedtomidine is a commonly used sedative that can be used as part of an anesthetic during surgery. In vitro and animal studies have shown that dexmedtomidine decreases the inflammatory response but no research has been conducted with cancer-related conditions.

Objective: To determine if dexmedtomidine, when used intraoperatively, can decrease the levels of inflammation in patients a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment.

Primary Objective:

Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.

Secondary Objectives Reduction in Cancer markers: CEA (carcinoembyronic antigen] and CA19-9 Reduction in opioid use Reduction in volatile usage (average sevoflurane end-tidal level)

Research Design: In this pilot study, 20 patients undergoing a HIPEC procedure as part of their cancer treatment will be randomized into 2 groups. One group (controls) will receive the current anesthetic standard of care. The second group (experimental) will also receive the current anesthetic standard of care with the addition of an infusion of dexmedtomidine during the surgical procedure. Biomarkers of inflammation (Lactate, CRP, ESR, plasma viscosity, NLR, PLR, and procalcitonin) and cancer markers (CEA and CA19-9) will be measured at 5 time points: pre-operatively, intra-opertatively prior to chemotherapy, post-operatively in the post-anaesthetic care unit, post-operative day 1, and post-operative day 5. Quantitative analysis of the inflammatory markers will be used to compare the two groups.

Statistical Analysis: Data will be summarized and t-tests will be used to compare the data from the 2 groups.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1 group will receive placebo drug delivery (Normal Saline infusion). The 2nd group will receive the study drug infusion (Dexmedetomidine)
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: A blinded syringe with either the placebo or study drug will be given to the anesthesiologist involved in that patient's care. All other care providers will be blinded to the study group
Primary Purpose: Prevention
Official Title: Dexmedetomidine and Inflammation in HIPEC Cases: A Case Series
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Normal Saline will be infused as per the protocol
Drug: Placebos
Normal Saline will be infused as a control drug

Experimental: Intervention group
Dexmedetomidine will be infused as per the protocol
Drug: Dexmedetomidine
Drug infusion will be delivered intra-operatively




Primary Outcome Measures :
  1. Inflammation [ Time Frame: 5 days ]
    Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.


Secondary Outcome Measures :
  1. Cancer recurrance [ Time Frame: 5 days ]
    Reduction in Cancer markers: CEA (carcinoembyronic antigen] and CA19-9

  2. Anesthesia Dose [ Time Frame: 5 days ]
    Reduction in volatile usage (average sevoflurane end-tidal level)

  3. Opioid use [ Time Frame: 5 days ]
    Reduction in opioid use



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment at Vancover General Hospital
  • 18 years of age or older
  • Able to provide informed consent
  • Expected stay 5 days or greater in hospital
  • Presenting for HIPEC with Colon or Appendix Cancer

Exclusion Criteria:

  • Contraindication to dexmedtomidine use including allergy or sensitivity to the drug
  • Pregnancy
  • Dementia
  • ASA greater than or equal to 4
  • Significant liver disease
  • Current use of steroid or immunosuppressive medication
  • Mesothelioma tumour origin
  • Current use of clonidine
  • Current opioid use exceeding 30mg of oral morphine equivalents
  • Patient not eligible or patient refusal to have a thoracic epidural

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04106999


Locations
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Canada, British Columbia
UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics
Vancouver, British Columbia, Canada, V5Z 1L8
Sponsors and Collaborators
University of British Columbia

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Responsible Party: Jason Wilson, Clinical Assistant Professor, University of British Columbia
ClinicalTrials.gov Identifier: NCT04106999    
Other Study ID Numbers: H19-00859
First Posted: September 27, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We may publish this research and share at a conference or through a research paper

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action