General Versus Regional Anesthesia and Postoperative Sleep Quality

NCT03843645 | Unknown

• 1 other identifier: AnesthSleep
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

  preoperative status, 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

  preoperative status, three months postoperatively

Secondary Outcomes (1)

• sleep diary

  first postoperative week

Study Arms (2)

general anesthesia group

ACTIVE COMPARATOR

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

Procedure: general anesthesia

regional anesthesia group

ACTIVE COMPARATOR

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

Procedure: regional anesthesia

Interventions

general anesthesia PROCEDURE

surgical procedure under general anesthesia

general anesthesia group

regional anesthesia PROCEDURE

surgical procedure under regional anesthesia

regional anesthesia group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Aretaieion University Hospital: lead

Study Sites (1)

Aretaieion University Hospital

Athens, 115 28, Greece

RECRUITING

Related Publications (12)

• 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.

  PMID: 8652329 BACKGROUND

• 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. doi: 10.1136/bmj.290.6474.1029.

  PMID: 3921096 BACKGROUND

• Lehmkuhl P, Prass D, Pichlmayr I. General anesthesia and postnarcotic sleep disorders. Neuropsychobiology. 1987;18(1):37-42. doi: 10.1159/000118390.

  PMID: 3444524 BACKGROUND

• 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.

  PMID: 2360740 BACKGROUND

• 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.

  PMID: 8322996 BACKGROUND

• 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.

  PMID: 1811316 BACKGROUND

• 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.

  PMID: 23460574 BACKGROUND

• 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.

  PMID: 22831887 BACKGROUND

• 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.

  PMID: 2748771 BACKGROUND

• 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.

  PMID: 1751279 BACKGROUND

• 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.

  PMID: 8110563 BACKGROUND

• Horne JA. Sleep loss and "divergent" thinking ability. Sleep. 1988 Dec;11(6):528-36. doi: 10.1093/sleep/11.6.528.

  PMID: 3238256 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Sleep Wake Disorders; Sleep Deprivation; Sleep Disorders, Circadian Rhythm; Sleep Initiation and Maintenance Disorders

Interventions

Anesthesia, General; Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyssomnias; Chronobiology Disorders; Occupational Diseases; Sleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Kassiani Theodoraki, PhD

  Aretaieion University Hospital, Faculty of Medicine, University of Athens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kassiani Theodoraki, PhD

CONTACT

+306974634162; ktheodoraki@hotmail.com

Aikaterini Liosi, MD

CONTACT

katerina_liosi@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The investigator completing the questionnaires will not be aware of patient group assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 18, 2019
• Study Start: February 10, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

GR (1)