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

Phase 4

Completed

• Conditions: General Anesthesia, Thoracic Epidural Anesthesia
• Interventions: Procedure: general anesthesia combined with TEA; Drug: general anesthesia combined with dexmedetomidine infusion

• Registration Number: NCT01725607
• Lead Sponsor: China Medical University, China

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 Timeline

• Study First Submitted: 2012-11-03
• Study First Submitted QC: 2012-11-08
• Study First Posted: 2012-11-14
• Study Start: 2013-01
• Status Verified: 2013-10
• Primary Completion: 2014-02
• Study Completion: 2014-03
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• lung surgery
• one-lung ventilation.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
general anesthesia combined with TEA	general anesthesia combined with TEA	general anesthesia combined with TEA (Group E)
general anesthesia combined with dexmedetomidine infusion	general anesthesia combined with dexmedetomidine infusion	general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)

Primary Outcome Measures

Name	Time	Method
inflammatory cytokine secretion and postoperative sleep quality	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 Outcome Measures

Name	Time	Method
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)	amine (epinephrine and norepinephrine) secretion during the surgical period and hemodynamic stability

Trial Locations

Locations (1)

Department of Anesthesiology, the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China