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Clinical Trials/NCT06523881
NCT06523881
Completed
Not Applicable

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

Uludag University1 site in 1 country40 target enrollmentJune 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Disturbance
Sponsor
Uludag University
Enrollment
40
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Completed
Last Updated
last year

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.

Registry
clinicaltrials.gov
Start Date
June 20, 2022
End Date
March 1, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Uludag University
Responsible Party
Principal Investigator
Principal Investigator

Yücel Bilgin

Orthopedics and Traumatology Surgeon (Spine Surgery)

Uludag University

Eligibility Criteria

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.

Study Sites (1)

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