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

Primary Purpose

Anesthesia, Surgery, Sleep Disorders

Status
Recruiting
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
maintenance with desflurane
maintenance with propofol
Sponsored by
Aretaieion University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Anesthesia

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 elective upper major abdominal surgery

Exclusion Criteria:

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

Sites / Locations

  • Aretaieion University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

maintenance with desflurane

maintenance with propofol

Arm Description

in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane

in patients allocated to the propofol group, general anesthesia will be maintained with propofol

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

sleep diary
cortisol levels
prolactin levels
melatonin levels
change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at three months postoperatively

Full Information

First Posted
February 7, 2014
Last Updated
February 5, 2023
Sponsor
Aretaieion University Hospital
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02061514
Brief Title
The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality
Official Title
The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aretaieion University Hospital
Collaborators
Baxter Healthcare Corporation

4. Oversight

Data Monitoring Committee
Yes

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 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Surgery, Sleep Disorders

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
maintenance with desflurane
Arm Type
Experimental
Arm Description
in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane
Arm Title
maintenance with propofol
Arm Type
Active Comparator
Arm Description
in patients allocated to the propofol group, general anesthesia will be maintained with propofol
Intervention Type
Procedure
Intervention Name(s)
maintenance with desflurane
Intervention Description
in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane
Intervention Type
Procedure
Intervention Name(s)
maintenance with propofol
Intervention Description
in patients allocated to the propofol group, general anesthesia will be maintained with propofol
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
sleep diary
Time Frame
first postoperative week
Title
cortisol levels
Time Frame
within the first 24 hours postoperatively
Title
prolactin levels
Time Frame
within the first 24 hours postoperatively
Title
melatonin levels
Time Frame
within the first 48 hours postoperatively
Title
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

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 elective upper major abdominal surgery Exclusion Criteria: Alcoholism Mental disability Psychiatric disease (depression, dementia) Preoperative use of sleeping medication
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kassiani Theodoraki, PhD, DEAA
Phone
#306974634162
Email
ktheodoraki@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kassiani Theodoraki, PhD, DEAA
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthaios Stamelos, MD
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eriphylli Argyra, PhD
Organizational Affiliation
Aretaieion University Hospital
Official's Role
Study Chair
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
First Name & Middle Initial & Last Name & Degree
Matthaios Stamelos, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
8652329
Citation
Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available.
Results Reference
background
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
background
PubMed Identifier
17377082
Citation
Steinmetz J, Holm-Knudsen R, Eriksen K, Marxen D, Rasmussen LS. Quality differences in postoperative sleep between propofol-remifentanil and sevoflurane anesthesia in infants. Anesth Analg. 2007 Apr;104(4):779-83. doi: 10.1213/01.ane.0000255694.00651.5b.
Results Reference
background
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
background
PubMed Identifier
9113194
Citation
Richardson J, Sabanathan S, Shah RD. Neuroendocrine response to mid and upper abdominal surgery. Acta Anaesthesiol Scand. 1997 Mar;41(3):433-4. doi: 10.1111/j.1399-6576.1997.tb04715.x. No abstract available.
Results Reference
background
PubMed Identifier
16477412
Citation
Bourne RS, Mills GH. Melatonin: possible implications for the postoperative and critically ill patient. Intensive Care Med. 2006 Mar;32(3):371-9. doi: 10.1007/s00134-005-0061-x. Epub 2006 Feb 14.
Results Reference
background
PubMed Identifier
20098135
Citation
Dispersyn G, Pain L, Touitou Y. Propofol anesthesia significantly alters plasma blood levels of melatonin in rats. Anesthesiology. 2010 Feb;112(2):333-7. doi: 10.1097/ALN.0b013e3181c920e2.
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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The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality

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