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

NCT02061514 | Unknown DMC

• 1 other identifier: SLEEP_ANNIE
• Study Type: interventional
• Target: 80
• 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 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

Conditions

Anesthesia; Surgery; Sleep Disorders

Outcome Measures

Primary Outcomes (1)

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

  preoperative status, one month postoperatively

Secondary Outcomes (5)

• sleep diary

  first postoperative week

• cortisol levels

  within the first 24 hours postoperatively

• prolactin levels

  within the first 24 hours postoperatively

• melatonin levels

  within the first 48 hours postoperatively

• change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at three months postoperatively

  preoperative status, three months postoperatively

Study Arms (2)

maintenance with desflurane

EXPERIMENTAL

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

Procedure: maintenance with desflurane

maintenance with propofol

ACTIVE COMPARATOR

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

Procedure: maintenance with propofol

Interventions

maintenance with desflurane PROCEDURE

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

maintenance with desflurane

maintenance with propofol PROCEDURE

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

maintenance with propofol

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 elective upper major abdominal surgery

You may not qualify if:

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

Sponsors & Collaborators

• Aretaieion University Hospital: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Aretaieion University Hospital

Athens, 115 28, Greece

RECRUITING

Related Publications (8)

• 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

• 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

• 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.

  PMID: 17377082 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

• 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.

  PMID: 9113194 BACKGROUND

• 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.

  PMID: 16477412 BACKGROUND

• 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.

  PMID: 20098135 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

MeSH Terms

Conditions

Sleep Wake Disorders

Interventions

Maintenance; Desflurane; Propofol

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Care Facilities Workforce and Services; Ethyl Ethers; Ethers; Organic Chemicals; Methyl Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Kassiani Theodoraki, PhD, DEAA

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

• Matthaios Stamelos, MD

  Aretaieion University Hospital

  PRINCIPAL INVESTIGATOR

• Eriphylli Argyra, PhD

  Aretaieion University Hospital

  STUDY CHAIR

Central Study Contacts

Kassiani Theodoraki, PhD, DEAA

CONTACT

#306974634162; ktheodoraki@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Anesthesiology

Study Record Dates

• First Submitted: February 7, 2014
• First Posted: February 13, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

GR (1)