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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370588
• Other study ID #: 4-2017-0372
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: May 27, 2019

Study information

• Verified date: December 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 27, 2019
• Est. primary completion date: May 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Inflammation

Intervention

Drug:
• 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.
• Normal saline
Group B: Saline infusion during same time period.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	recurrence rate	To evaluate the effect of dexmedetomidine on the recurrence rate up to 1 year after surgery were collected.	up to 1 year after surgery