AnesthesiaNCT02061514
The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality
A study testing maintenance with desflurane and maintenance with propofol in people with Anesthesia and Surgery, run by Aretaieion University Hospital at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, Surgery, Sleep Disorders
- What is being tested?
- maintenance with desflurane and maintenance with propofol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2014to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery
Who cannot join
- Alcoholism
- Mental disability
- Psychiatric disease (depression, dementia)
- Preoperative use of sleeping medication
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Aretaieion University Hospital
Athens, 115 28
Kassiani Theodoraki, PhD, DEAA, #306974634162, ktheodoraki@hotmail.com
Kassiani Theodoraki, PhD, DEAA
About this study
- 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
Read the 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 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 sleep architecture, since sleep is an altered state of consciousness like anesthesia. So, the aim of this study will be to assess the effect of two different anesthetic techniques of maintaining general anesthesia in patients subjected to similar major operations
- 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 with general anesthesia maintenance based on an intravenous agent (propofol) and a second group with general anesthesia maintenance based on an inhalational agent (desflurane)
- 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
- Since anesthetic-related differences in hormone profiles are expected, markers related to the neuroendocrine response to stress (cortisol, prolactin) will also be assessed to investigate differences between the two different anesthetic regimes
- Impaired melatonin secretion has been proposed as one of the mechanisms involved in postoperative sleep disturbances. It is therefore expected that different methods of anesthetic maintenance may affect the endogenous circadian melatonin rhythm in a different way. Consequently, melatonin secretion will also be measured to investigate potential desynchronization of melatonin rhythm as well as differences in melatonin secretion between the two different anesthetic techniques
- 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
- Conditions
- Anesthesia, Surgery, Sleep Disorders
- Being tested
- maintenance with desflurane, maintenance with propofol
- Medical subject headings
- Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance with desfluraneProcedure or surgery
in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane
maintenance with propofolProcedure or surgery
in patients allocated to the propofol group, general anesthesia will be maintained with propofol
| Study group | Role | What they receive |
|---|---|---|
| maintenance with desflurane | Experimental | in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane Receives: Procedure: maintenance with desflurane |
| maintenance with propofol | Active comparator | in patients allocated to the propofol group, general anesthesia will be maintained with propofol Receives: Procedure: maintenance with propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at one month postoperatively
Measured: preoperative status, one month postoperatively
Secondary outcomes (5)
sleep diary
Measured: first postoperative week
cortisol levels
Measured: within the first 24 hours postoperatively
prolactin levels
Measured: within the first 24 hours postoperatively
melatonin levels
Measured: within the first 48 hours postoperatively
change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at three months postoperatively
Measured: preoperative status, three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aretaieion University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Dr Kassiani Theodoraki, Aretaieion University Hospital
- Investigators
- Kassiani Theodoraki, PhD, DEAA, Principal investigator, Aretaieion University HospitalMatthaios Stamelos, MD, Principal investigator, Aretaieion University HospitalEriphylli Argyra, PhD, Study chair, Aretaieion University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061514
- Sponsor's protocol ID
- SLEEP_ANNIE
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2014
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1093/bja/76.4.552. No abstract available.
PubMed 8652329Knill 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.
PubMed 2360740Steinmetz 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.
PubMed 17377082Buysse 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.
PubMed 2748771Richardson 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.
PubMed 9113194Bourne 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.
PubMed 16477412Dispersyn 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.
PubMed 20098135Lehmkuhl P, Prass D, Pichlmayr I. General anesthesia and postnarcotic sleep disorders. Neuropsychobiology. 1987;18(1):37-42. doi: 10.1159/000118390.
PubMed 3444524
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different General Anesthesia Regimes on Postoperative Sleep Quality
- ClinicalTrials.gov ID
- NCT02061514
- Acronym / sponsor ID
- SLEEP_ANNIE
- Conditions
- Anesthesia, Surgery, Sleep Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Aretaieion University HospitalUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Mar 2014
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
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 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 sleep architecture, since sleep is an altered state of consciousness like anesthesia. So, the aim of this study will be to assess the effect of two different anesthetic techniques of maintaining general anesthesia in patients subjected to similar major operations
- 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 with general anesthesia maintenance based on an intravenous agent (propofol) and a second group with general anesthesia maintenance based on an inhalational agent (desflurane)
- 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
- Since anesthetic-related differences in hormone profiles are expected, markers related to the neuroendocrine response to stress (cortisol, prolactin) will also be assessed to investigate differences between the two different anesthetic regimes
- Impaired melatonin secretion has been proposed as one of the mechanisms involved in postoperative sleep disturbances. It is therefore expected that different methods of anesthetic maintenance may affect the endogenous circadian melatonin rhythm in a different way. Consequently, melatonin secretion will also be measured to investigate potential desynchronization of melatonin rhythm as well as differences in melatonin secretion between the two different anesthetic techniques
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| maintenance with desflurane | Experimental | Procedure: maintenance with desfluranein patients allocated to the desflurane group, general anesthesia will be maintained with desflurane |
| maintenance with propofol | Active comparator | Procedure: maintenance with propofolin patients allocated to the propofol group, general anesthesia will be maintained with propofol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients, American Society of Anesthesiologists (ASA) distribution I-III, scheduled for elective upper major abdominal surgery
Key exclusion criteria (4 listed)
- Alcoholism
- Mental disability
- Psychiatric disease (depression, dementia)
- Preoperative use of sleeping medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maintenance with desfluranein patients allocated to the desflurane group, general anesthesia will be maintained with desflurane | Procedure or surgery | maintenance with desflurane |
| maintenance with propofolin patients allocated to the propofol group, general anesthesia will be maintained with propofol | Procedure or surgery | maintenance with propofol |
Primary outcome
change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at one month postoperatively
Time frame: preoperative status, one month postoperatively
5 secondary outcomes
sleep diary
Time frame: first postoperative week
cortisol levels
Time frame: within the first 24 hours postoperatively
prolactin levels
Time frame: within the first 24 hours postoperatively
melatonin levels
Time frame: within the first 48 hours postoperatively
change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at three months postoperatively
Time frame: preoperative status, three months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Background: PubMed 8652329Rosenberg-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.
- Background: PubMed 2360740Knill 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.
- Background: PubMed 17377082Steinmetz 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.
- Background: PubMed 2748771Buysse 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.
- Background: PubMed 9113194Richardson 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.
- Background: PubMed 16477412Bourne 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.
- Background: PubMed 20098135Dispersyn 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.
- Background: PubMed 3444524Lehmkuhl P, Prass D, Pichlmayr I. General anesthesia and postnarcotic sleep disorders. Neuropsychobiology. 1987;18(1):37-42. doi: 10.1159/000118390.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kassiani Theodoraki, PhD, DEAA principal investigator
Aretaieion University Hospital
Matthaios Stamelos, MD principal investigator
Aretaieion University Hospital
Eriphylli Argyra, PhD study chair
Aretaieion University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing maintenance with desflurane and maintenance with propofol in people with Anesthesia and Surgery, run by Aretaieion University Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kassiani Theodoraki, PhD, DEAA (#306974634162, ktheodoraki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from preoperative status of subjective sleep quality (evaluated by Pittburgh Sleep Quality Index) at one month postoperatively (time frame: preoperative status, one month postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02061514, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.