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NCT Number: NCT03370588

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

normal saline

Drug

Group B: Saline infusion during same time period.

Primary outcomes

  1. IL-6 level

    Time frame: 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 outcomes

  1. recurrence rate

    Time frame: up to 1 year after surgery

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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2017
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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