Intravenous Dexmedetomidine Versus Thoracic Epidural Anesthesia in Patients Undergoing Thoracic Surgery
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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 |
- 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.
- 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | May 2013 (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 |
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| Contact: Wen-fei Tan, M.D.,PhD | 8602483283100 | winfieldtan@hotmail.com |
| China, Liaoning | |
| Department of Anesthesiology, the First Hospital of China Medical University | Recruiting |
| Shenyang, Liaoning, China, 110001 | |
| Contact: Hong Ma, M.D.,PhD. 8602483283100 mahong196366@yahoo.com.cn | |
| Principal Investigator: Wen-fei Tan, M.D.,PhD. | |
| 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: | February 3, 2013 |
| Health Authority: | China: Ethics Committee |
Keywords provided by China Medical University, China:
|
dexmedetomidine, thoracic epidural anesthesia |
Additional relevant MeSH terms:
|
Anesthetics Dexmedetomidine Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Hypnotics and Sedatives Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013