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

July 24, 2024 updated by: Yücel Bilgin, Uludag University

Evaluation of the 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Nilufer
      • Bursa, Nilufer, Turkey, 16059
        • Uludag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group P
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.
Procedure: Propofol (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.
Active Comparator: Group S
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.
Procedure: Sevoflurane (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pittsburgh Insomnia Rating Scale-20
Time Frame: Preoperative one month
Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.
Preoperative one month
Pittsburgh Insomnia Rating Scale-20
Time Frame: Postoperative seventh day
Sleep score: Minimum value:0 Maximum value:60 Higher scores mean a worse outcome.
Postoperative seventh day
Visual Analogue Scale
Time Frame: Preoperative one day
Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.
Preoperative one day
Visual Analogue Scale
Time Frame: Postoperative first hour
Pain score: Minimum value:0 Maximum value:10 Higher scores mean a worse outcome.
Postoperative first hour
State-Trait Anxiety Inventory
Time Frame: Preoperative one day
Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.
Preoperative one day
State-Trait Anxiety Inventory
Time Frame: Postoperative seventh day
Anxiety score: Minimum value:20 Maximum value:80 Higher scores mean a worse outcome.
Postoperative seventh day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uludag University

Investigators

  • Principal Investigator: Yücel Bilgin, MD, Uludag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2022

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

March 1, 2024

Study Registration Dates

First Submitted

July 12, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 26, 2024

Study Record Updates

Last Update Posted (Actual)

July 26, 2024

Last Update Submitted That Met QC Criteria

July 24, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UU-YB-2024-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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