Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

Yonsei University Health System (YUHS)

Status and phase: Completed; Phase 4

Conditions: Malignant Tumor

Treatments: Drug: Normal Saline; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02641938

3-2015-0262

Details and patient eligibility

About

To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

Full description

A cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. Dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. It may also enhance a renal perfusion by inhibition of renal sympathoexcitation. We hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.

Enrollment: 38 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of malignant tumor with peritoneal metastasis
• Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy

Exclusion criteria

• Preoperative chronic kidney disease stage ≥4 defined by KDOQI ( eGFR < 30 mL/min/1.73m2)
• Congestive heart failure
• Atrioventricular block > 1st degree
• Bradycardia < 45 beat per minute
• History of myocardial infarction within 3 months
• Pregnancy

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Experimental group

Description:

1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery

Treatment:

Drug: Dexmedetomidine

Normal Saline

Placebo Comparator group

Description:

IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery

Treatment:

Drug: Normal Saline