The Effects of Dexmedetomidine on Inflammatory Mediators After One Lung Ventilation During Video-assisted Thoracoscopic Surgery

NCT02439905 | Completed Phase 4

• 1 other identifier: 201410035MINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

During lung surgery, mechanical one-lung ventilation is usually mandatory to provide appropriate surgical condition. However, not only mechanical ventilation is associated with inflammatory response, but also one lung ventilation will result in detrimental effects such as ischemia and reperfusion injury, and systemic inflammatory responses. Dexmedetomidine is an alpha-2 selective agonist. It was reported that dexmedetomidine decreased reperfusion injury, reduce the release of proinflammatory mediator and protected lungs from reperfusion injury in esophageal cancer patients who undergoing one lung ventilation from reducing oxidative stress metabolites. However, other details of protective effects is still unknown. High mobility group box 1 (HMGB1) is an important proinflammatory factor. It was found to be related to ventilator induced lung injury in several condition. Animal studies also showed that dexmedetomidine reduces the expression of messenger ribonucleic acid in lipopolysaccharide-activated macrophage so that decrease the amount of HMGB1 release. However, clinical trials about these are still lacking. In this study, we will investigate the protective effects of dexmedetomidine to patients undergoing video-assisted thoracoscopic surgery, especially on the specific inflammatory markers- plasma HMGB1 and other inflammatory cytokines (eg. interleukin-1. interleukin-6). This will let us to know the role of HMGB1 during one-lung ventilation injury and the effect of dexmedetomidine in regulating the release of HMGB1. This study will become a basis of further medical therapy in treating inflammation.

Conditions

One Lung Ventilation in Thoracic Surgery

Keywords

inflammatory cytokine; protective effect; Dexmedetomidine; Precedex; one lung ventilation; ischemia-reperfusion

Outcome Measures

Primary Outcomes (1)

• Postoperative plasma level of HMGB1

  2 days

Secondary Outcomes (1)

• Postoperative complications

  during hospital stay, an expected average of one week

Other Outcomes (1)

• Postoperative pain score

  2 days

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Drug: Dexmedetomidine

Normal saline group

PLACEBO COMPARATOR

Drug: Placebo control

Interventions

Dexmedetomidine DRUG

In dexmedetomidine group, dexmedetomidine infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.

Dexmedetomidine group

Placebo control DRUG

In normal saline group, normal saline infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.

Normal saline group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical classification I-II patients who receive VATS lobectomy
• Patients with the following will be excluded:
• suspect of infection, eg. white blood cell count\> 10000 ; fever\> 38.3℃
• preoperative cardiac or renal dysfunction, eg. New York Heart Association \>= II, estimated glomerular filtration rate\< 60
• predisposing liver dysfunction, eg. aspartate aminotransferase or alanine aminotransferase \>100; total bilirubin\> 2mg/dl; \>= Child B liver cirrhosis

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Chun-Yu Wu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: May 12, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

TW (1)