Colon Cancer
Conditions
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.
Interventions
DRUGdexmedetomidine
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.
DRUGNormal saline
Group B: Saline infusion during same time period.
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Investigator prepared the drug and participant and outcomes assessor were blind to the group allocation
Intervention model description
Double blind randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
South Korea
Outcome results
None listed