General Versus Regional Anesthesia and Postoperative Sleep Quality (AnesthSleep)

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ClinicalTrials.gov Identifier: NCT03843645

Recruitment Status : Recruiting

First Posted : February 18, 2019

Last Update Posted : April 14, 2021

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Sponsor:

Information provided by (Responsible Party):

Dr Kassiani Theodoraki, Aretaieion University Hospital

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

Condition or disease	Intervention/treatment	Phase
Anesthesia Surgery Sleep Disturbance Sleep Disorder Sleep Fragmentation Sleep Disorders, Circadian Rhythm Sleep Initiation and Maintenance Disorders Sleep	Procedure: general anesthesia Procedure: regional anesthesia	Not Applicable

Detailed Description:

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

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Masking Description:	The investigator completing the questionnaires will not be aware of patient group assignment
Primary Purpose:	Prevention
Official Title:	The Effect of General Versus Regional Anesthesia on Postoperative Sleep Quality
Actual Study Start Date :	February 10, 2019
Estimated Primary Completion Date :	December 31, 2021
Estimated Study Completion Date :	December 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: general anesthesia group patients allocated to the general anesthesia group will be subjected to general anesthesia with sevoflurane (inhalational agent) used for maintenance	Procedure: general anesthesia surgical procedure under general anesthesia
Active Comparator: regional anesthesia group patients allocated to the regional anesthesia group will be subjected to combined spinal-epidural anesthesia with ropivacaine and fentanyl	Procedure: regional anesthesia surgical procedure under regional anesthesia

Outcome Measures

Primary Outcome Measures :

subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) [ Time Frame: preoperative status, one month postoperatively ]
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) [ Time Frame: preoperative status, three months postoperatively ]
change from preoperative status of subjective sleep quality (evaluated by Pittsburgh Sleep Quality Index) at three months postoperatively

Secondary Outcome Measures :

sleep diary [ Time Frame: first postoperative week ]
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)

Eligibility Criteria

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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 saphenectomy

Exclusion Criteria:

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

Contacts and Locations

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): NCT03843645

Contacts

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Contact: Kassiani Theodoraki, PhD	+306974634162	ktheodoraki@hotmail.com
Contact: Aikaterini Liosi, MD		katerina_liosi@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

Sponsors and Collaborators

Aretaieion University Hospital

Investigators

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Principal Investigator:	Kassiani Theodoraki, PhD	Aretaieion University Hospital, Faculty of Medicine, University of Athens

More Information

Publications:

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. Review.

Aurell J, Elmqvist D. Sleep in the surgical intensive care unit: continuous polygraphic recording of sleep in nine patients receiving postoperative care. Br Med J (Clin Res Ed). 1985 Apr 6;290(6474):1029-32.

Lehmkuhl P, Prass D, Pichlmayr I. General anesthesia and postnarcotic sleep disorders. Neuropsychobiology. 1987;18(1):37-42.

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.

Brimacombe J, Macfie AG. Peri-operative nightmares in surgical patients. Anaesthesia. 1993 Jun;48(6):527-9.

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.

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.

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.

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.

Reeder MK, Muir AD, Foëx P, Goldman MD, Loh L, Smart D. Postoperative myocardial ischaemia: temporal association with nocturnal hypoxaemia. Br J Anaesth. 1991 Nov;67(5):626-31. Erratum in: Br J Anaesth 1993 Jan;70(1):119.

Rosenberg J, Wildschiødtz 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.

Horne JA. Sleep loss and "divergent" thinking ability. Sleep. 1988 Dec;11(6):528-36.

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Responsible Party:	Dr Kassiani Theodoraki, Associate Professor of Anesthesiology, Aretaieion University Hospital
ClinicalTrials.gov Identifier:	NCT03843645
Other Study ID Numbers:	AnesthSleep
First Posted:	February 18, 2019 Key Record Dates
Last Update Posted:	April 14, 2021
Last Verified:	April 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Dr Kassiani Theodoraki, Aretaieion University Hospital:


anesthesia, general anesthesia, regional sleep disorder REM stage

Additional relevant MeSH terms:

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Sleep Wake Disorders Parasomnias Dyssomnias Sleep Initiation and Maintenance Disorders Sleep Deprivation Sleep Disorders, Circadian Rhythm Disease Pathologic Processes Nervous System Diseases	Neurologic Manifestations Mental Disorders Sleep Disorders, Intrinsic Chronobiology Disorders Occupational Diseases Anesthetics Central Nervous System Depressants Physiological Effects of Drugs

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