Dexmedetomidine and HIPEC
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|ClinicalTrials.gov Identifier: NCT04106999|
Recruitment Status : Not yet recruiting
First Posted : September 27, 2019
Last Update Posted : September 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Inflammation Cancer||Drug: Dexmedetomidine Drug: Placebos||Phase 2 Phase 3|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
|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|
Placebo Comparator: Placebo
Normal Saline will be infused as per the protocol
Normal Saline will be infused as a control drug
Experimental: Intervention group
Dexmedetomidine will be infused as per the protocol
Drug infusion will be delivered intra-operatively
- Inflammation [ Time Frame: 5 days ]Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.
- Cancer recurrance [ Time Frame: 5 days ]Reduction in Cancer markers: CEA (carcinoembyronic antigen] and CA19-9
- Anesthesia Dose [ Time Frame: 5 days ]Reduction in volatile usage (average sevoflurane end-tidal level)
- Opioid use [ Time Frame: 5 days ]Reduction in opioid use
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
|Canada, British Columbia|
|UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics|
|Vancouver, British Columbia, Canada, V5Z 1L8|