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

Not Applicable

Completed

• Conditions: Sleep Disturbance; Anesthesia; Adverse Effect
• Interventions: Procedure: Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey); Procedure: Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey)

• Registration Number: NCT06523881
• Lead Sponsor: Uludag University

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 Timeline

• Study Start: 2022-06-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-12
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-24
• Study First Posted: 2024-07-26
• Last Update Posted: 2024-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group P	Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)	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.
Group S	Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey)	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Uludag University; 🇹🇷 Bursa, Nilufer, Turkey