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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) | Procedure | Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) is a medication used during anesthesia. It is administered by inhalation with an anesthesia device. |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Insomnia Rating Scale-20 | Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome. | Preoperative one month |
| Pittsburgh Insomnia Rating Scale-20 | Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome. | Postoperative seventh day |
| Visual Analogue Scale | Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome. | Preoperative one day |
| Visual Analogue Scale | Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome. | Postoperative first hour |
| State-Trait Anxiety Inventory | Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome. | Preoperative one day |
| State-Trait Anxiety Inventory | Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome. | Postoperative seventh day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yücel Bilgin, MD | Uludag University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uludag University | Bursa | Nilufer | 16059 | Turkey (Türkiye) |
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| Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey) | Procedure | Propofol is a drug used during anesthesia. It is administered intravenously using an infusion pump during surgical procedures. |
|
| ID | Term |
|---|---|
| D020447 | Parasomnias |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D000077149 | Sevoflurane |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D009930 | Organic Chemicals |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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