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

NCT03370588 | Completed

• 1 other identifier: 4-2017-0372
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 12 hours after surgery

Secondary Outcomes (1)

• recurrence rate

  up to 1 year after surgery

Study Arms (2)

dexmedetomidine infusion group

EXPERIMENTAL

Drug: dexmedetomidine

normal saline infusion group

ACTIVE COMPARATOR

Drug: Normal saline

Interventions

dexmedetomidine DRUG

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.

dexmedetomidine infusion group

Normal saline DRUG

Group B: Saline infusion during same time period.

normal saline infusion group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

Location

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Dexmedetomidine; Saline Solution

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized controlled trial

Study Record Dates

• First Submitted: November 21, 2017
• First Posted: December 12, 2017
• Study Start: December 1, 2017
• Primary Completion: May 27, 2019
• Study Completion: May 27, 2019
• Last Updated: December 4, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)