The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality
NCT02061514 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2023-02-08
Summary
* Major surgery can lead to postoperative disturbances in sleep patterns with subjective deterioration of sleep quality according to patients' reports as well as objective alterations of sleep architecture, as recorded by polysomnography
* Factors implicated in postoperative sleep disturbances include but are not limited to the severity of the surgical procedure, the neuroendocrine response to surgery, inadequate treatment of postoperative pain and external factors interfering with sleep, such as light, noise and therapeutic procedures
* There are differences in the molecular mechanisms inhalational anesthetics and intravenous agents affect different brain regions to induce anesthesia. Our hypothesis is that these differences may also be evident during the postoperative period, affecting brain functions which are involved in postoperative sleep architecture. So, the aim of this study will be to assess the effect of two different anesthetic techniques (propofol versus desflurane) of maintaining general anesthesia in patients subjected to similar major operations
* Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI), regarding preoperative and long term postoperative sleep quality, sleep diaries regarding early postoperative sleep quality and biochemical markers (cortisol, prolactin and melatonin) regarding neuroendocrine response to surgery and disturbances in endogenous circadian secretion associated with sleep
Conditions
- Anesthesia
- Surgery
- Sleep Disorders
Interventions
- PROCEDURE
-
maintenance with desflurane
in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane
- PROCEDURE
-
maintenance with propofol
in patients allocated to the propofol group, general anesthesia will be maintained with propofol
Sponsors & Collaborators
-
Baxter Healthcare Corporation
collaborator INDUSTRY -
Aretaieion University Hospital
lead OTHER
Principal Investigators
-
Kassiani Theodoraki, PhD, DEAA · Aretaieion University Hospital
-
Matthaios Stamelos, MD · Aretaieion University Hospital
-
Eriphylli Argyra, PhD · Aretaieion University Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-03-31
- Primary Completion
- 2024-12-31
- Completion
- 2024-12-31
Countries
- Greece
Study Locations
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