Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04106999 |
| Other study ID # |
H19-00859 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
March 2023 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
November 2022 |
| Source |
University of British Columbia |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 the investigators would like determine if a commonly used sedative drug
(dexmedtomidine) has an impact on this inflammatory state when used as part of the
anesthetic. The investigators 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. The investigators 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.
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.
