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

NCT ID: NCT04007341

Last Updated: 2019-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-29

Study Completion Date

2019-01-18

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Saline group

Patients in the saline group were infused with an identical volume of normal saline.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

The study drug for each group was administered from the time immediately after induction of anesthesia until the end of the surgery.

Interventions

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Dexmedetomidine

The study drug for each group was administered from the time immediately after induction of anesthesia until the end of the surgery.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wonjung Hwang

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul St.Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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KC16MISI0042

Identifier Type: -

Identifier Source: org_study_id

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