Postoperative Sleep Quality in Patients Undergoing Thoracic Surgery With Different Types of Anesthesia Management
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 219
- Locations
- 1
- Primary Endpoint
- inflammatory cytokine secretion and postoperative sleep quality
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- 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
Arms & Interventions
general anesthesia combined with dexmedetomidine infusion
general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
Intervention: general anesthesia combined with dexmedetomidine infusion (Drug)
general anesthesia combined with TEA
general anesthesia combined with TEA (Group E)
Intervention: general anesthesia combined with TEA (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- amine 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))
Investigators
Wen-fei Tan
associate professor
China Medical University, China