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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

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Yonsei University

Status

Completed

Conditions

Colon Cancer

Treatments

Drug: Normal saline
Drug: dexmedetomidine

Study type

Interventional

Funder types

Other

Identifiers

NCT03370588
4-2017-0372

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

20 to 70 years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

56 participants in 2 patient groups

dexmedetomidine infusion group
Experimental group
Treatment:
Drug: dexmedetomidine
normal saline infusion group
Active Comparator group
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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