Dexmedetomidine and HIPEC

Sponsor

University of British Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04106999

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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 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.

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.

Study Design

Study Type:

Interventional

Anticipated 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)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

Anticipated Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Inflammation [5 days]
Reduction in inflammatory markers: CRP, ESR, NLR, PLR, plasma viscosity, lactate.

Secondary Outcome Measures

Cancer recurrance [5 days]
Reduction in Cancer markers: CEA (carcinoembyronic antigen] and CA19-9
Anesthesia Dose [5 days]
Reduction in volatile usage (average sevoflurane end-tidal level)
Opioid use [5 days]
Reduction in opioid use

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics	Vancouver	British Columbia	Canada	V5Z 1L8

Sponsors and Collaborators

University of British Columbia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jason Wilson, Clinical Assistant Professor, University of British Columbia

ClinicalTrials.gov Identifier:

NCT04106999

Other Study ID Numbers:

H19-00859

First Posted:

Sep 27, 2019

Last Update Posted:

May 13, 2021

Last Verified:

May 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Inflammation

Dexmedetomidine

Study Results

No Results Posted as of May 13, 2021