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

NCT ID: NCT03370588

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2019-05-27

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

dexmedetomidine infusion group

Group Type: EXPERIMENTAL

dexmedetomidine

Intervention Type: 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.

normal saline infusion group

Group Type: ACTIVE_COMPARATOR

Normal saline

Intervention Type: DRUG

Group B: Saline infusion during same time period.

Interventions

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.

Intervention Type: DRUG

Normal saline

Group B: Saline infusion during same time period.

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2017-0372

Identifier Type: -

Identifier Source: org_study_id