NCT04007341

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

July 5, 2019

Status Verified

June 1, 2019

Enrollment Period

6 months

First QC Date

July 1, 2019

Last Update Submit

July 2, 2019

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Interleukin (IL)-6

    Blood samples were collected from the antecubital vein

    24 hours after surgery

Study Arms (2)

Saline group

NO INTERVENTION

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

Dexmedetomidine group

EXPERIMENTAL

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

Interventions

DexmedetomidineDRUG

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

Dexmedetomidine group

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul St.Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 1, 2019

First Posted

July 5, 2019

Study Start

July 29, 2018

Primary Completion

January 18, 2019

Study Completion

January 18, 2019

Last Updated

July 5, 2019

Record last verified: 2019-06

Locations

KR(1)