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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2014

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.

Interventions

  • Drug: general anesthesia combined with dexmedetomidine infusion
    • general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
  • Procedure: general anesthesia combined with TEA
    • general anesthesia combined with TEA (Group E)

Arms, Groups and Cohorts

  • 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)
  • Experimental: general anesthesia combined with TEA
    • general anesthesia combined with TEA (Group E)

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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

Participating in This Clinical Trial

Inclusion Criteria

  • lung surgery – one-lung ventilation. Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • China Medical University, China
  • Provider of Information About this Clinical Study
    • Principal Investigator: Wen-fei Tan, associate professor – China Medical University, China
  • Overall Official(s)
    • Hong Ma, M.D.,PhD., Study Chair, Dept. of Anesthesiology, the First Hospital of CMU

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