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General Versus Regional Anesthesia and Postoperative Sleep Quality (AnesthSleep)

Primary Purpose

Anesthesia, Surgery, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
general anesthesia
regional anesthesia
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia focused on measuring anesthesia, general, anesthesia, regional, sleep disorder, REM stage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for saphenectomy

Exclusion Criteria:

  • Alcoholism
  • Mental disability
  • Psychiatric disease (depression, dementia)
  • Preoperative use of sleeping medication
  • Language barriers
  • Lack of informed consent

Sites / Locations

  • Aretaieion University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

general anesthesia group

regional anesthesia group

Arm Description

patients allocated to the general anesthesia group will be subjected to general anesthesia with sevoflurane (inhalational agent) used for maintenance

patients allocated to the regional anesthesia group will be subjected to combined spinal-epidural anesthesia with ropivacaine and fentanyl

Outcomes

Primary Outcome Measures

subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index)
change from preoperative status of subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) at one month postoperatively
subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index)
change from preoperative status of subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) at three months postoperatively

Secondary Outcome Measures

sleep diary
subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality)

Full Information

First Posted
February 14, 2019
Last Updated
April 24, 2023
Sponsor
Aretaieion University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03843645
Brief Title
General Versus Regional Anesthesia and Postoperative Sleep Quality
Acronym
AnesthSleep
Official Title
The Effect of General Versus Regional Anesthesia on Postoperative Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 no adequate data from current literature as to whether regional anesthesia is superior to general anesthesia regarding postoperative sleep quality in patients subjected to either mode of anesthesia. So, the aim of this study will be to assess the effect of two different anesthetic techniques (general versus regional) in patients subjected to similar operations Patients will be assessed with the Pittsburgh Sleep Quality Questionnaire (PSQI), regarding preoperative and long term postoperative sleep quality and sleep diaries regarding early postoperative sleep quality
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 no adequate data from current literature as to whether regional anesthesia is superior to general anesthesia regarding postoperative sleep quality in patients subjected to either mode of anesthesia. There have been a few studies evaluating the effect of regional anesthesia on postoperative sleep quality after orthopedic procedures, without however comparing regional to general anesthesia in this setting. preliminary data from these studies suggest that regional anesthesia can also lead to postoperative sleep disturbances during the first postoperative nights, such as causing a reduction of REM stage. So, the aim of this study will be to assess the effect of two different anesthetic techniques (general versus regional) in patients subjected to a similar operative procedure (saphenectomy). 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 subjected to general anesthesia (maintenance with sevoflurane) and a second group subjected to combined spinal-epidural anesthesia 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Surgery, Sleep Disturbance, Sleep Disorder, Sleep Fragmentation, Sleep Disorders, Circadian Rhythm, Sleep Initiation and Maintenance Disorders, Sleep
Keywords
anesthesia, general, anesthesia, regional, sleep disorder, REM stage

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The investigator completing the questionnaires will not be aware of patient group assignment
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
general anesthesia group
Arm Type
Active Comparator
Arm Description
patients allocated to the general anesthesia group will be subjected to general anesthesia with sevoflurane (inhalational agent) used for maintenance
Arm Title
regional anesthesia group
Arm Type
Active Comparator
Arm Description
patients allocated to the regional anesthesia group will be subjected to combined spinal-epidural anesthesia with ropivacaine and fentanyl
Intervention Type
Procedure
Intervention Name(s)
general anesthesia
Intervention Description
surgical procedure under general anesthesia
Intervention Type
Procedure
Intervention Name(s)
regional anesthesia
Intervention Description
surgical procedure under regional anesthesia
Primary Outcome Measure Information:
Title
subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index)
Description
change from preoperative status of subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) at one month postoperatively
Time Frame
preoperative status, one month postoperatively
Title
subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index)
Description
change from preoperative status of subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) at three months postoperatively
Time Frame
preoperative status, three months postoperatively
Secondary Outcome Measure Information:
Title
sleep diary
Description
subjective evaluation of sleep quality by patients, based on a sleep questionnaire (evaluation of sleep duration, number of nocturnal awakenings and marking of sleep quality)
Time Frame
first postoperative week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for saphenectomy Exclusion Criteria: Alcoholism Mental disability Psychiatric disease (depression, dementia) Preoperative use of sleeping medication Language barriers Lack of informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kassiani Theodoraki, PhD
Phone
+306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Aikaterini Liosi, MD
Email
katerina_liosi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD
Organizational Affiliation
Aretaieion University Hospital, Faculty of Medicine, University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aretaieion University Hospital
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DEAA
Phone
#306974634162
Email
ktheodoraki@hotmail.com
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DEAA

12. IPD Sharing Statement

Citations:
PubMed Identifier
8652329
Citation
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Results Reference
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PubMed Identifier
3921096
Citation
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Results Reference
background
PubMed Identifier
3444524
Citation
Lehmkuhl P, Prass D, Pichlmayr I. General anesthesia and postnarcotic sleep disorders. Neuropsychobiology. 1987;18(1):37-42. doi: 10.1159/000118390.
Results Reference
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PubMed Identifier
2360740
Citation
Knill RL, Moote CA, Skinner MI, Rose EA. Anesthesia with abdominal surgery leads to intense REM sleep during the first postoperative week. Anesthesiology. 1990 Jul;73(1):52-61. doi: 10.1097/00000542-199007000-00009.
Results Reference
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PubMed Identifier
8322996
Citation
Brimacombe J, Macfie AG. Peri-operative nightmares in surgical patients. Anaesthesia. 1993 Jun;48(6):527-9. doi: 10.1111/j.1365-2044.1993.tb07078.x.
Results Reference
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PubMed Identifier
1811316
Citation
Libert JP, Bach V, Johnson LC, Ehrhart J, Wittersheim G, Keller D. Relative and combined effects of heat and noise exposure on sleep in humans. Sleep. 1991 Feb;14(1):24-31. doi: 10.1093/sleep/14.1.24.
Results Reference
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PubMed Identifier
23460574
Citation
Dette F, Cassel W, Urban F, Zoremba M, Koehler U, Wulf H, Graf J, Steinfeldt T. Occurrence of rapid eye movement sleep deprivation after surgery under regional anesthesia. Anesth Analg. 2013 Apr;116(4):939-43. doi: 10.1213/ANE.0b013e3182860e58. Epub 2013 Mar 4.
Results Reference
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PubMed Identifier
22831887
Citation
Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.
Results Reference
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PubMed Identifier
2748771
Citation
Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
Results Reference
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PubMed Identifier
1751279
Citation
Reeder MK, Muir AD, Foex P, Goldman MD, Loh L, Smart D. Postoperative myocardial ischaemia: temporal association with nocturnal hypoxaemia. Br J Anaesth. 1991 Nov;67(5):626-31. doi: 10.1093/bja/67.5.626. Erratum In: Br J Anaesth 1993 Jan;70(1):119.
Results Reference
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PubMed Identifier
8110563
Citation
Rosenberg J, Wildschiodtz G, Pedersen MH, von Jessen F, Kehlet H. Late postoperative nocturnal episodic hypoxaemia and associated sleep pattern. Br J Anaesth. 1994 Feb;72(2):145-50. doi: 10.1093/bja/72.2.145.
Results Reference
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PubMed Identifier
3238256
Citation
Horne JA. Sleep loss and "divergent" thinking ability. Sleep. 1988 Dec;11(6):528-36. doi: 10.1093/sleep/11.6.528.
Results Reference
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General Versus Regional Anesthesia and Postoperative Sleep Quality

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