Skip to main content
OpenTrials
Completed

NCT Number: NCT06523881

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Disturbance Anesthesia; Adverse Effect Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uludag University

Bursa, Nilufer, 16059, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pittsburgh Insomnia Rating Scale-20

    Time frame: Preoperative one month

    Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.

  2. Pittsburgh Insomnia Rating Scale-20

    Time frame: Postoperative seventh day

    Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.

  3. Visual Analogue Scale

    Time frame: Preoperative one day

    Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.

  4. Visual Analogue Scale

    Time frame: Postoperative first hour

    Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.

  5. State-Trait Anxiety Inventory

    Time frame: Preoperative one day

    Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.

  6. State-Trait Anxiety Inventory

    Time frame: Postoperative seventh day

    Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Uludag University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 26, 2024
Registry last updated
Jul 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.