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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-20

Study Completion Date

2024-03-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Sleep Disturbance Anesthesia; Adverse Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Propofol is a drug used during anesthesia. It is administered intravenously using an infusion pump during surgical procedures.

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Sevoflurane (Sevorane® liquid 100%, Abbvie Pharmaceuticals, Istanbul, Turkey) is a medication used during anesthesia. It is administered by inhalation with an anesthesia device.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No