Dexmedetomidine and HIPEC

NCT04106999 | Unknown Phase 2

• 1 other identifier: H19-00859
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Cancer

Outcome Measures

Primary Outcomes (1)

• Inflammation

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

  5 days

Secondary Outcomes (3)

• Cancer recurrance

  5 days

• Anesthesia Dose

  5 days

• Opioid use

  5 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal Saline will be infused as per the protocol

Drug: Placebos

Intervention group

EXPERIMENTAL

Dexmedetomidine will be infused as per the protocol

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

Drug infusion will be delivered intra-operatively

Intervention group

Placebos DRUG

Normal Saline will be infused as a control drug

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a Hyperthermic Intraperitoneal Chemotherapy (HIPEC) procedure as part of their cancer treatment at Vancover General Hospital
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics

Vancouver, British Columbia, V5Z 1L8, Canada

Location

MeSH Terms

Conditions

Inflammation; Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 1 group will receive placebo drug delivery (Normal Saline infusion). The 2nd group will receive the study drug infusion (Dexmedetomidine)

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: March 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 3, 2022

Record last verified: 2022-11

Locations

CA (1)