Sleep DisturbanceNCT06523881
Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery
A study testing Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) and Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey) in people with Sleep Disturbance and Anesthesia; Adverse Effect, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to evaluate the impact of the anesthesia method and surgical procedure on the sleep patterns and sleep quality of patients undergoing posterior spinal instrumentation using the Pittsburgh Insomnia Rating Scale-20 (PIRS-20). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Anesthesia; Adverse Effect
- What is being tested?
- Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) and Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2022to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA (American Society of Anesthesiology) I-III
- Aged 18 and over
- Who underwent elective spinal posterior instrumentation
Who cannot join
- Aged 17 and under
- ASA (American Society of Anesthesiology) IV
- Presence of psychological illness
- Presence of psychological illness
- Presence of sleep disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery
Investigators aimed to evaluate the impact of the anesthesia method and surgical procedure on the sleep patterns and sleep quality of patients undergoing posterior spinal instrumentation using the Pittsburgh Insomnia Rating Scale-20 (PIRS-20).
Read the detailed description
A total of 40 participants ASA (American Society of Anesthesiology) I-III aged 18 and over who underwent elective spinal posterior instrumentation was included. The participants were divided into two groups randomly - those with sevoflurane and remifentanil anesthesia and those with total intravenous anesthesia (TIVA) - using the closed envelope method. Participants were evaluated before and after the surgery with the PIRS-20 (surgery one month previously and postoperative 7th day) for sleep quality, VAS (Visual Analogue Scale; recorded preoperative night and postoperative first hour), pain, and State-Trait Anxiety Inventory (STAI) for anxiety (recorded preoperative night and postoperative 7th day) scores.
- Conditions
- Sleep Disturbance, Anesthesia; Adverse Effect
- Being tested
- Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey), Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)
- Keywords
- posterior instrumentation, sleep quality, anesthetics, spine surgery
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey)Procedure or surgery
Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) is a medication used during anesthesia. It is administered by inhalation with an anesthesia device.
Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)Procedure or surgery
Propofol is a drug used during anesthesia. It is administered intravenously using an infusion pump during surgical procedures.
| Study group | Role | What they receive |
|---|---|---|
| Group P | Active comparator | Group P received propofol Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey) at a dosage of 75-100 µg/kg/min and remifentanil (Opiva vial®, Tum Ekip Pharmaceuticals Inc., Istanbul, Turkey) IV at a dosage of 0.05-0.2 µg/kg/min. Receives: Procedure: Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey) |
| Group S | Active comparator | Group S utilized sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) for anesthesia maintenance, with an end-tidal sevoflurane concentration ranging from 1 to 1.5 minimal alveolar concentrations. Furthermore, remifentanil (Opiva vial®, Tum Ekip Pharmaceuticals Inc., Istanbul, Turkey) was administered IV at an infusion rate ranging from 0.05 to 0.2 µg kg/min. Receives: Procedure: Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Insomnia Rating Scale-20
Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.
Measured: Preoperative one month
Pittsburgh Insomnia Rating Scale-20
Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.
Measured: Postoperative seventh day
Visual Analogue Scale
Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.
Measured: Preoperative one day
Visual Analogue Scale
Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.
Measured: Postoperative first hour
State-Trait Anxiety Inventory
Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.
Measured: Preoperative one day
State-Trait Anxiety Inventory
Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.
Measured: Postoperative seventh day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start20 Jun 2022
- Primary completion31 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep DisturbanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yücel Bilgin, Uludag University
- Investigators
- Yücel Bilgin, MD, Principal investigator, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06523881
- Sponsor's protocol ID
- UU-YB-2024-01
- Status last verified
- Jul 2024
- First submitted
- 12 Jul 2024
- Last updated
- 26 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery
- ClinicalTrials.gov ID
- NCT06523881
- Acronym / sponsor ID
- UU-YB-2024-01
- Conditions
- Sleep Disturbance, Anesthesia; Adverse Effect
- Keywords
- posterior instrumentation, sleep quality, anesthetics, spine surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 26 Jul 2024 (actual)
- 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.
Investigators aimed to evaluate the impact of the anesthesia method and surgical procedure on the sleep patterns and sleep quality of patients undergoing posterior spinal instrumentation using the Pittsburgh Insomnia Rating Scale-20 (PIRS-20).
Detailed description
A total of 40 participants ASA (American Society of Anesthesiology) I-III aged 18 and over who underwent elective spinal posterior instrumentation was included. The participants were divided into two groups randomly - those with sevoflurane and remifentanil anesthesia and those with total intravenous anesthesia (TIVA) - using the closed envelope method. Participants were evaluated before and after the surgery with the PIRS-20 (surgery one month previously and postoperative 7th day) for sleep quality, VAS (Visual Analogue Scale; recorded preoperative night and postoperative first hour), pain, and State-Trait Anxiety Inventory (STAI) for anxiety (recorded preoperative night and postoperative 7th day) scores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P | Active comparator | Procedure: Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)Group P received propofol Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey) at a dosage of 75-100 µg/kg/min and remifentanil (Opiva vial®, Tum Ekip Pharmaceuticals Inc., Istanbul, Turkey) IV at a dosage of 0.05-0.2 µg/kg/min. |
| Group S | Active comparator | Procedure: Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey)Group S utilized sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) for anesthesia maintenance, with an end-tidal sevoflurane concentration ranging from 1 to 1.5 minimal alveolar concentrations. Furthermore, remifentanil (Opiva vial®, Tum Ekip Pharmaceuticals Inc., Istanbul, Turkey) was administered IV at an infusion rate ranging from 0.05 to 0.2 µg kg/min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA (American Society of Anesthesiology) I-III
- Aged 18 and over
- Who underwent elective spinal posterior instrumentation
Key exclusion criteria (5 listed)
- Aged 17 and under
- ASA (American Society of Anesthesiology) IV
- Presence of psychological illness
- Presence of psychological illness
- Presence of sleep disorder
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 |
|---|---|---|
| Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey)Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) is a medication used during anesthesia. It is administered by inhalation with an anesthesia device. | Procedure or surgery | Group S |
| Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)Propofol is a drug used during anesthesia. It is administered intravenously using an infusion pump during surgical procedures. | Procedure or surgery | Group P |
Primary outcome
Pittsburgh Insomnia Rating Scale-20
Time frame: Preoperative one month
Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.
Pittsburgh Insomnia Rating Scale-20
Time frame: Postoperative seventh day
Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.
Visual Analogue Scale
Time frame: Preoperative one day
Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.
Visual Analogue Scale
Time frame: Postoperative first hour
Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.
State-Trait Anxiety Inventory
Time frame: Preoperative one day
Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.
State-Trait Anxiety Inventory
Time frame: Postoperative seventh day
Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2024.
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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.
Yücel Bilgin, MD principal investigator
Uludag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) and Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey) in people with Sleep Disturbance and Anesthesia; Adverse Effect, run by Uludag University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 26 Jul 2024. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Insomnia Rating Scale-20 (time frame: Preoperative one month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2024.