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

July 7, 2015 updated by: Wen-fei Tan, China Medical University, China
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • Department of Anesthesiology, the First Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lung surgery
  • one-lung ventilation.

Exclusion Criteria:

  • body mass index exceeding 30 kg/m2,
  • autonomic dysfunction,
  • cardiovascular disease,
  • neurological or psychiatric diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: the control group (Group C)
general anesthesia
EXPERIMENTAL: general anesthesia combined with dexmedetomidine infusion
general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
Drug: general anesthesia combined with dexmedetomidine infusion
general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
EXPERIMENTAL: general anesthesia combined with TEA
general anesthesia combined with TEA (Group E)
Procedure: general anesthesia combined with TEA
general anesthesia combined with TEA (Group E)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
inflammatory cytokine secretion and postoperative sleep quality
Time Frame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
Primary outcomes were inflammatory cytokine secretion and postoperative sleep quality, which was measured with the BIS data on first and second postoperative nights.
immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
amine secretion during the surgical period and hemodynamic stability
Time Frame: immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)
amine (epinephrine and norepinephrine) secretion during the surgical period and hemodynamic stability
immediately before anesthesia (T1), 5 min after endotracheal intubation (T2), immediately after incision (T3), 5 min after OLV initiation (T4), 5 min after double-lung ventilation initiation (T5), and immediately after extubation (T6)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

February 1, 2014

Study Completion (ACTUAL)

March 1, 2014

Study Registration Dates

First Submitted

November 3, 2012

First Submitted That Met QC Criteria

November 8, 2012

First Posted (ESTIMATE)

November 14, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 8, 2015

Last Update Submitted That Met QC Criteria

July 7, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20121101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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