Measuring Sleep Quality In Patients That Posterior Spinal Instrumentatıon Plannıng

NCT06269328 | Completed

• 1 other identifier: 2011-KAEK-26/463
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative sleep disorders have serious problems with cognition, pain perception, sustained circadian rhythm, psychomotor function, metabolic function, catabolic responses, and continuity. The relationship between general anesthesia and sleep disturbances following surgery is still unclear. Since the risk of sleep disorders after surgery is high, it is important to determine the efficiency of the interval with automatic sleep disorders. By evaluating how major orthopedic surgery and general anesthesia applied to posterior spinal instrumentation divides sleep quality, risk management allows determining the factors involved in the peroperative period and thus facilitating surgical results and patient comfort.

Conditions

Sleep Disorder; Sleep, Inadequate; Total ıntravenous Anesthesia; Inhalation Anesthesia

Keywords

Anesthesia; General anesthesia; Sleep quality; Total ıntravenous anesthesia; Inhalation anesthesia

Outcome Measures

Primary Outcomes (1)

• Subjective sleep quality (evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale)

  Sleep quality evaluated by PIRS-20 (Pitssburg Insomnia Rating Scale) , a scale provides ranging from 0 to 60 , with a high score indicating a poor quality of sleeping.

  Preoperative status a month before surgery and a day before surgery and one week postoperatively]

Secondary Outcomes (2)

• Subjective anxiety level

  Preoperative status a month before surgery and a day before surgery and one week postoperatively]

• Subjective pain level

  Preoperative status a month before surgery and a day before surgery and one week postoperatively]

Study Arms (2)

TIVA group

ACTIVE COMPARATOR

Patients will be anesthetized with total ıntravenous anesthesia by propofol and remifentanyl infusion. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period.

Other: Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance

İnhalation group

ACTIVE COMPARATOR

Patients will be anesthetized with induction of propofol and sevoflurane (inhalational agent) will be used for maintenance. End of the procedure all patients will be extubated and awakened in the operating room. İntravenous morphine patient-controlled analgesia will be used in the postoperative period.

Other: Inhalation anesthesia with sevoflurane for anesthetic maintenance

Interventions

Total ıntravenous anesthesia with propofol and remifentanil for anesthetic maintenance OTHER

For anesthesia induction, intravenous propofol was used at doses of 1-2 mg/kg, fentanyl at 2mcg/kg, lidocaine at 1mg/kg, and rocuronium at doses of 1mg/kg. After then anesthesia maintained with propofol iv 75-100 µg kg-1 min-1 and remifentanyl iv 0.05-0.2 µg kg-1 min-1 infusion.

TIVA group

Inhalation anesthesia with sevoflurane for anesthetic maintenance OTHER

For anesthesia induction, intravenous propofol was used at doses of 1-2 mg/kg, fentanyl at 2mcg/kg, lidocaine at 1mg/kg, and rocuronium at doses of 1mg/kg. After then anesthesia was maintained with inhalation anesthetic (50% O2/Air with Sevoflurane 2% )

İnhalation group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective total hip arthroplasty planning
• years and older patients
• ASA score between I-III
• Approved and signed the informed consent form

You may not qualify if:

• Patients under 18 years of age
• Patients with ASA score 4 and above
• Patients who do not accept informed consent
• Those who refuse to participate in the study

Sponsors & Collaborators

• Uludag University: lead

Study Sites (1)

Elifgül Ulutaş

Bursa, Nilüfer, 16240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Deprivation; Sleep Initiation and Maintenance Disorders

Interventions

Propofol; Remifentanil; Anesthesia, Inhalation; Sevoflurane

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Dyssomnias; Sleep Disorders, Intrinsic

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anesthesia, General; Anesthesia; Anesthesia and Analgesia; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: February 21, 2024
• Study Start: July 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)