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Intravenous Dexmedetomidine Versus Thoracic Epidural Anesthesia in Patients Undergoing Thoracic Surgery

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: March 17, 2014
Last verified: October 2013
  Purpose

The investigators designed a study to determine whether a single-dose of dexmedetomidine versus thoracic epidural anesthesia (TEA) combined with general anesthesia would provide improved hemodynamic stability and reduce the stress hormone responses in patients undergoing thoracic surgery with one-lung ventilation.


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: Comparing the Effect of Intravenous Dexmedetomidine With Thoracic Epidural Anesthesia in Patients Undergoing Thoracic Surgery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • invasive blood pressure,arterial blood gas and bispectral index score monitoring [ 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 ]
    Routine monitoring was applied pre-operatively including a radial artery catheter contralateral to the operated site for invasive blood pressure monitoring and arterial blood gas sampling. Heart rate and mean arterial blood pressure (MAP) were continuously monitored. Arterial oxygen saturation was monitored by pulse oximetry. Inspired oxygen fraction, end-tidal sevoflurane concentration and end-tidal carbon dioxide were measured. The bispectral index score (BIS) was monitored using a BIS sensor.


Secondary Outcome Measures:
  • measuring the plasma concentrations of epinephrine, norepinephrine and cortisol. [ 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 ]
    In the operating room, after placement of the epidural catheter at T4-6 in patients of Group E, a test dose of 3 mL of 1% lidocaine was administered to exclude intrathecal catheter placement.After pre-oxygenation for 3min, general anesthesia was induced with midazolam 0.04 mg/kg, sufentanil 0.5μg/kg, propofol 2-2.5mg/kg and rocuronium 0.6 mg/kg. A left-side double-lumen tube was inserted and the correct position was assured by auscultation and by fibreoptic bronchoscopy before and after the patient was in the lateral decubitus position. The patient's lung was ventilated with an intermittent positive pressure. Plasma samples were taken upon arrival to the operating room for measurements of epinephrine, norepinephrine, and cortisol in each of the three groups.


Enrollment: 45
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:

The investigators designed a prospective, randomized, placebo-controlled study to determine whether a single-dose of dexmedetomidine versus thoracic epidural anesthesia (TEA) combined with general anesthesia would provide improved hemodynamic stability and reduce the stress hormone responses in patients undergoing thoracic surgery with one-lung ventilation.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: March 17, 2014
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 November 25, 2014