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Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery

Evaluation of the Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06523881
Enrollment
40
Registered
2024-07-26
Start date
2022-06-20
Completion date
2024-03-01
Last updated
2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia; Adverse Effect, Sleep Disturbance

Keywords

posterior instrumentation, sleep quality, anesthetics, spine surgery

Brief 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).

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.

Interventions

PROCEDURESevoflurane (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.

PROCEDUREPropofol (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.

Sponsors

Uludag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* ASA (American Society of Anesthesiology) I-III * Aged 18 and over * Who underwent elective spinal posterior instrumentation

Exclusion criteria

* Aged 17 and under * ASA (American Society of Anesthesiology) IV * Presence of psychological illness * Presence of psychological illness * Presence of sleep disorder

Design outcomes

Primary

MeasureTime frameDescription
Pittsburgh Insomnia Rating Scale-20Preoperative one monthSleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.
Visual Analogue ScalePreoperative one dayPain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.
State-Trait Anxiety InventoryPreoperative one dayAnxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026