Effect of Dexmedetomidine on the Inflammatory Response After One-lung Ventilation

Effect of Dexmedetomidine on the Inflammatory Response in Patients Undergoing Lung Resection Surgery

The postoperative inflammatory response is significant in lung resection surgery because of major operation and one-lung ventilation. Dexmedetomidine has been shown to reduce pro-inflammatory cytokine levels and improve clinical outcomes. The aim of this study was to determine the effects of dexmedetomidine on inflammatory responses after lung resection surgery.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul St.Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective video-assisted thoracoscopic surgery (VATS) lobectomy
• 20 < age < 75
• American Society of Anesthesiologists (ASA) classification I~II

Exclusion Criteria:

• preoperative inflammation (CRP>10ng/#, WBC>10,000/mm3, body temperature >38#)
• steroid administration within 1 month
• hematologic / autoimmune disease
• congestive heart failure (NYHA class III~IV) or significant arrhythmia
• severe obstructive / restrictive pulmonary disease
• previous history of thoracic surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Saline group; Patients in the saline group were infused with an identical volume of normal saline.
Experimental: Dexmedetomidine group; Patients in the dexmedetomidine group were infused with a loading dose of dexmedetomidine (1.0 mcg/kg over 10 min) and were thereafter infused at a rate of 0.5 mg/kg/h.	Drug: Dexmedetomidine; The study drug for each group was administered from the time immediately after induction of anesthesia until the end of the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interleukin (IL)-6	Blood samples were collected from the antecubital vein	24 hours after surgery

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2018
• Primary Completion (Actual): January 18, 2019
• Study Completion (Actual): January 18, 2019

Study Registration Dates

• First Submitted: July 1, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2019
• Last Update Submitted That Met QC Criteria: July 2, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: KC16MISI0042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No