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The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality

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ClinicalTrials.gov Identifier: NCT02061514
Recruitment Status : Recruiting
First Posted : February 13, 2014
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Dr Kassiani Theodoraki, Aretaieion University Hospital

Brief 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

Condition or disease Intervention/treatment Phase
Anesthesia Surgery Sleep Disorders Procedure: maintenance with desflurane Procedure: maintenance with propofol Not Applicable

Detailed Description:
  • 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
  • These disturbances include severe sleep fragmentation, rapid eye movement (REM) and slow wave sleep significant reductions in duration as well as an increase in non-REM sleep stages. Spontaneous awakenings are also frequently reported
  • After the third or fourth postoperative day, there is a substantial rebound in total REM activity, with frequent reports of vivid nightmares
  • 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 sleep architecture, since sleep is an altered state of consciousness like anesthesia. So, the aim of this study will be to assess the effect of two different anesthetic techniques of maintaining general anesthesia in patients subjected to similar major operations
  • Patients taking part in the study will be evaluated regarding their preoperative sleep quality by the Pittsburgh Sleep Quality Questionnaire (PSQI). The PSQI examines seven components of sleep quality retrospectively over a period of four weeks: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction over the last month. The patient self-rates each of these seven areas of sleep. Scoring of answers is based on a 0-3 scale, whereby '3' reflects the negative extreme on the Likert scale. The global score is generated by summing up all seven component scores and ranges from 0 to 21, with higher values corresponding to reduced sleep quality.
  • Consequently, patients will be randomized to one of two groups: one group with general anesthesia maintenance based on an intravenous agent (propofol) and a second group with general anesthesia maintenance based on an inhalational agent (desflurane)
  • Patients will be assessed postoperatively with sleep diaries regarding potential sleep disturbances while they will be subjected to a long-term assessment of sleep quality by the use of the PSQI one and three months postoperatively
  • Since anesthetic-related differences in hormone profiles are expected, markers related to the neuroendocrine response to stress (cortisol, prolactin) will also be assessed to investigate differences between the two different anesthetic regimes
  • Impaired melatonin secretion has been proposed as one of the mechanisms involved in postoperative sleep disturbances. It is therefore expected that different methods of anesthetic maintenance may affect the endogenous circadian melatonin rhythm in a different way. Consequently, melatonin secretion will also be measured to investigate potential desynchronization of melatonin rhythm as well as differences in melatonin secretion between the two different anesthetic techniques
  • The clinical implications of this study lie in the fact that postoperative sleep disturbances can lead to postoperative hemodynamic instability, episodic hypoxemia and mental status deterioration, which can all untowardly affect the short and long-term postoperative outcome. It would be interesting to determine whether one of the two anesthetic regimes is superior to the other as far as postoperative disturbances in sleep architecture are concerned

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality
Study Start Date : March 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: maintenance with desflurane
in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane
Procedure: maintenance with desflurane
in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane

Active Comparator: maintenance with propofol
in patients allocated to the propofol group, general anesthesia will be maintained with propofol
Procedure: maintenance with propofol
in patients allocated to the propofol group, general anesthesia will be maintained with propofol




Primary Outcome Measures :
  1. change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at one month postoperatively [ Time Frame: preoperative status, one month postoperatively ]

Secondary Outcome Measures :
  1. sleep diary [ Time Frame: first postoperative week ]
  2. cortisol levels [ Time Frame: within the first 24 hours postoperatively ]
  3. prolactin levels [ Time Frame: within the first 24 hours postoperatively ]
  4. melatonin levels [ Time Frame: within the first 48 hours postoperatively ]
  5. change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at three months postoperatively [ Time Frame: preoperative status, three months postoperatively ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery

Exclusion Criteria:

  • Alcoholism
  • Mental disability
  • Psychiatric disease (depression, dementia)
  • Preoperative use of sleeping medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061514


Contacts
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Contact: Kassiani Theodoraki, PhD, DEAA #306974634162 ktheodoraki@hotmail.com

Locations
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Greece
Aretaieion University Hospital Recruiting
Athens, Greece, 115 28
Contact: Kassiani Theodoraki, PhD, DEAA    #306974634162    ktheodoraki@hotmail.com   
Principal Investigator: Kassiani Theodoraki, PhD, DEAA         
Principal Investigator: Matthaios Stamelos, MD         
Sponsors and Collaborators
Aretaieion University Hospital
Baxter Healthcare Corporation
Investigators
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Principal Investigator: Kassiani Theodoraki, PhD, DEAA Aretaieion University Hospital
Principal Investigator: Matthaios Stamelos, MD Aretaieion University Hospital
Study Chair: Eriphylli Argyra, PhD Aretaieion University Hospital

Publications:
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Responsible Party: Dr Kassiani Theodoraki, Associate Professor in Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier: NCT02061514     History of Changes
Other Study ID Numbers: SLEEP_ANNIE
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Anesthetics
Propofol
Desflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics, Inhalation