General Versus Regional Anesthesia and Postoperative Sleep Quality (AnesthSleep)

April 24, 2023 updated by: Dr Kassiani Theodoraki, Aretaieion University Hospital

The Effect of General Versus Regional Anesthesia on Postoperative Sleep Quality

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
      • Athens, Greece, 115 28
        • Recruiting
        • Aretaieion University Hospital
        • Principal Investigator:
          • Kassiani Theodoraki, PhD, DEAA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
preoperative status, 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
preoperative status, three months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
first postoperative week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aretaieion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2019

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 15, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AnesthSleep

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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