Evaluation of the Effects of Anesthetics and Surgery on Sleep Quality in Patients Undergoing Posterior Spinal Instrumentation Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Visual Analogue Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
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: Postoperative seventh day
Anxiety score: Minimum value:20 Maximum value:80 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Yücel Bilgin
Orthopedics and Traumatology Surgeon (Spine Surgery)
Uludag University