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

NCT06523881 | Completed

• 1 other identifier: UU-YB-2024-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Disturbance; Anesthesia; Adverse Effect

Keywords

posterior instrumentation; sleep quality; anesthetics; spine surgery

Outcome Measures

Primary Outcomes (6)

• Pittsburgh Insomnia Rating Scale-20

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

  Preoperative one month

• Pittsburgh Insomnia Rating Scale-20

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

  Postoperative seventh day

• Visual Analogue Scale

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

  Preoperative one day

• Visual Analogue Scale

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

  Postoperative first hour

• State-Trait Anxiety Inventory

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

  Preoperative one day

• State-Trait Anxiety Inventory

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

  Postoperative seventh day

Study Arms (2)

Group P

ACTIVE COMPARATOR

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)

Group S

ACTIVE COMPARATOR

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)

Interventions

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.

Group S

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.

Group P

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA (American Society of Anesthesiology) I-III
• Aged 18 and over
• Who underwent elective spinal posterior instrumentation

You may not qualify if:

• Aged 17 and under
• ASA (American Society of Anesthesiology) IV
• Presence of psychological illness
• Presence of psychological illness
• Presence of sleep disorder

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Uludag University

Bursa, Nilufer, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Interventions

Sevoflurane; Propofol

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Study Officials

• Yücel Bilgin, MD

  Uludag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedics and Traumatology Surgeon (Spine Surgery)

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 26, 2024
• Study Start: June 20, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: July 26, 2024

Record last verified: 2024-07

Locations

TU (1)