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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02061514 on ClinicalTrials.gov