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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

Primary Purpose

Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

dexmedetomidine

Normal saline

About this trial

This is an interventional supportive care trial for Colon Cancer

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

dexmedetomidine infusion group

normal saline infusion group

Arm Description

Outcomes

Primary Outcome Measures

IL-6 level

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.

Secondary Outcome Measures

recurrence rate

To evaluate the effect of dexmedetomidine on the recurrence rate up to 1 year after surgery were collected.

Full Information

NCT ID

NCT03370588

First Posted

November 21, 2017

Last Updated

December 2, 2019

Sponsor

Yonsei University

1. Study Identification

Unique Protocol Identification Number

NCT03370588

Brief Title

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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Completed

Study Start Date

December 1, 2017 (Actual)

Primary Completion Date

May 27, 2019 (Actual)

Study Completion Date

May 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Double blind randomized controlled trial

Masking

ParticipantOutcomes Assessor

Masking Description

Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

dexmedetomidine infusion group

Arm Type

Experimental

Arm Title

normal saline infusion group

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

dexmedetomidine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Normal saline

Intervention Description

Group B: Saline infusion during same time period.

Primary Outcome Measure Information:

Title

IL-6 level

Description

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.

Time Frame

Up to 12 hours after surgery

Secondary Outcome Measure Information:

Title

recurrence rate

Description

To evaluate the effect of dexmedetomidine on the recurrence rate up to 1 year after surgery were collected.

Time Frame

up to 1 year after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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