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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wen-fei Tan, China Medical University, China
ClinicalTrials.gov Identifier:
NCT01725607
First received: November 3, 2012
Last updated: July 7, 2015
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
General Anesthesia, Thoracic Epidural Anesthesia
Drug: general anesthesia combined with dexmedetomidine infusion
Procedure: general anesthesia combined with TEA
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management

Resource links provided by NLM:


Further study details as provided by China Medical University, China:

Primary Outcome 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) ] [ Designated as safety issue: Yes ]
    Primary outcomes were inflammatory cytokine secretion and postoperative sleep quality, which was measured with the BIS data on first and second postoperative nights.


Secondary Outcome 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) ] [ Designated as safety issue: Yes ]
    amine (epinephrine and norepinephrine) secretion during the surgical period and hemodynamic stability


Enrollment: 219
Study Start Date: January 2013
Study Completion Date: March 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • lung surgery
  • one-lung ventilation.

Exclusion Criteria:

  • body mass index exceeding 30 kg/m2,
  • autonomic dysfunction,
  • cardiovascular disease,
  • neurological or psychiatric diseases
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01725607

Locations
China, Liaoning
Department of Anesthesiology, the First Hospital of China Medical University
Shenyang, Liaoning, China, 110001
Sponsors and Collaborators
China Medical University, China
Investigators
Study Chair: Hong Ma, M.D.,PhD. Dept. of Anesthesiology, the First Hospital of CMU
  More Information

No publications provided

Responsible Party: Wen-fei Tan, associate professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT01725607     History of Changes
Other Study ID Numbers: 20121101
Study First Received: November 3, 2012
Last Updated: July 7, 2015
Health Authority: China: Ethics Committee

Keywords provided by China Medical University, China:
dexmedetomidine, thoracic epidural anesthesia

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2015