The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial

December 2, 2019 updated by: Yonsei University
Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has been reported to be an effective treatment approach for peritoneal cancer, however, the stress response to HIPEC is major neuroendocrine and cytokine response, which has been considered as the homeostatic defense mechanism. Recently, dexmedetomidine has been suggested to exhibit anti-inflammatory properties. This study was designed to evaluate the effect of perioperative administration of dexmedetomidine on inflammation response and postoperative outcomes in patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients between 20 and 70 years old
  • obtaining written informed consent from the patients who were undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery
  • weights under 90 kg and BMI under 32

Exclusion Criteria:

  • emergency operation
  • re-operations
  • combined surgery over 4 departments.
  • cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
  • Ventricular conduction abnormality
  • prior pacemaker insertion
  • uncontrolled hypertension (diastolic blood pressure > 110mmHg)
  • bradycardia (HR < 40 Bpm)
  • cerebral vascular disease (cerebral hemorrhage, cerebral ischemia)
  • hepatic or renal failure
  • patients who take antiarrythmic agent
  • neurological or psychiatric illnesses
  • foreigner and patient who can not read the letter

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dexmedetomidine infusion group
Drug: dexmedetomidine
Group A: dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum. Group B: Saline infusion during same time period.
Active Comparator: normal saline infusion group
Drug: Normal saline
Group B: Saline infusion during same time period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL-6 level
Time Frame: Up to 12 hours after surgery
To evaluate the effect of dexmedetomidine on the level of IL-6 in patient undergoing HIPEC, IL-6 level was measured up to 12 hours after surgery.
Up to 12 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recurrence rate
Time Frame: up to 1 year after surgery
To evaluate the effect of dexmedetomidine on the recurrence rate up to 1 year after surgery were collected.
up to 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Actual)

May 27, 2019

Study Completion (Actual)

May 27, 2019

Study Registration Dates

First Submitted

November 21, 2017

First Submitted That Met QC Criteria

December 6, 2017

First Posted (Actual)

December 12, 2017

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 2, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-0372

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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