Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management

NCT ID: NCT01725607

Last Updated: 2015-07-08

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

PHASE4

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-03-31

Brief Summary

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We designed a study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

Detailed Description

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We designed a prospective, single-blinded, randomized, and controlled study to determine whether a single dose of dexmedetomidine or thoracic epidural anesthesia combined with general anesthesia would provide hemodynamic stability, reduce stress hormone responses, inhibit inflammatory cytokine secretion, and improve sleep quality in patients after thoracic surgery.

Conditions

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General Anesthesia, Thoracic Epidural Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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the control group (Group C)

general anesthesia

Group Type NO_INTERVENTION

No interventions assigned to this group

general anesthesia combined with dexmedetomidine infusion

general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)

Group Type EXPERIMENTAL

general anesthesia combined with dexmedetomidine infusion

Intervention Type DRUG

general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)

general anesthesia combined with TEA

general anesthesia combined with TEA (Group E)

Group Type EXPERIMENTAL

general anesthesia combined with TEA

Intervention Type PROCEDURE

general anesthesia combined with TEA (Group E)

Interventions

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general anesthesia combined with dexmedetomidine infusion

general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)

Intervention Type DRUG

general anesthesia combined with TEA

general anesthesia combined with TEA (Group E)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* lung surgery
* one-lung ventilation.

Exclusion Criteria

* body mass index exceeding 30 kg/m2,
* autonomic dysfunction,
* cardiovascular disease,
* neurological or psychiatric diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wen-fei Tan

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Ma, M.D.,PhD.

Role: STUDY_CHAIR

Dept. of Anesthesiology, the First Hospital of CMU

Locations

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Department of Anesthesiology, the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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20121101

Identifier Type: -

Identifier Source: org_study_id

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