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

Bursa Uludag University

Status: Completed

Conditions: Anesthesia; Adverse Effect; Sleep Disturbance

Treatments: Procedure: Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey); Procedure: Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)

Study type: Interventional

Funder types: Other

Identifiers

NCT06523881

UU-YB-2024-01

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Group P

Active Comparator group

Description:

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.

Treatment:

Procedure: Propofol (Propofol-PF® 1% (Polifarma Pharmaceuticals, Tekirdag, Turkey)

Group S

Active Comparator group

Description:

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.

Treatment:

Procedure: Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey)