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

Not Applicable

Completed

• Conditions: Colon Cancer
• Interventions: Drug: Normal saline; Drug: dexmedetomidine

• Registration Number: NCT03370588
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study Start: 2017-12-01
• Study First Submitted QC: 2017-12-06
• Study First Posted: 2017-12-12
• Primary Completion: 2019-05-27
• Study Completion: 2019-05-27
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
normal saline infusion group	Normal saline	-
dexmedetomidine infusion group	dexmedetomidine	-

Primary Outcome Measures

Name	Time	Method
IL-6 level	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine; 🇰🇷 Seoul, Korea, Republic of