General Versus Regional Anesthesia and Postoperative Sleep Quality

Surgery Clinical Trial

— AnesthSleep  

Official title:

The Effect of General Versus Regional Anesthesia on Postoperative Sleep Quality

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03843645
• Other study ID #: AnesthSleep
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Aretaieion University Hospital
• Contact: Kassiani Theodoraki, PhD
• Phone: +306974634162
• Email: ktheodoraki[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Disease
• Dyssomnias
• Parasomnias
• Sleep
• Sleep Deprivation
• Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Disturbance
• Sleep Fragmentation
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders
• Surgery

Intervention

Procedure:
• general anesthesia
surgical procedure under general anesthesia
• regional anesthesia
surgical procedure under regional anesthesia

Locations

Country	Name	City	State
Greece	Aretaieion University Hospital	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View Citation

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

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

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)	first postoperative week