GENERAL vs. REGIONAL ANESTHESIA ON SLEEP QUALITY FOR HIP ARTROPLASTY PATIENTS

NCT06041711 | Completed

• 1 other identifier: 2011-KAEK-26
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system.Sleep disorders, which may occur in the perioperative period as short-term or long-term, affect many patients. Patients have to face with perioperative sleep disorders, and this situation can continue for a long time after surgery. Anesthetic agents may cause sleep disturbances in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause sleep insufficiency and poor sleep quality. The relationship between general anesthesia and postoperative sleep disorders is still unclear. It is advantageous to identify patients with pre-existing sleep disorders, since the risk of postoperative sleep disturbance is high. The investigators hypothesis that regional anesthesia does not disrupt the circadian rhythm compared to general anesthesia, is more successful in pain control, and thus provides a better sleep quality for patients.

Conditions

Sleep Disturbance; Postoperative Complications; Regional Anesthesia Morbidity

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)

General anesthesia group

ACTIVE COMPARATOR

Patients allocated to the general anesthesia group will be subjected to general anesthesia with induction with propofol and will sevoflurane (inhalational agent) 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.

Procedure: General anesthesia with propofol induction and sevoflurane maintenance

Regional anesthesia group

ACTIVE COMPARATOR

Patients allocated to the regional anesthesia group will be subjected to combined spinal-epidural anesthesia with heavy bupivacaine or spinal anesthesia with PENG(pericapsular nerve group) block with bupivacaine. If lumbar combined spinal epidural anesthesia is applied epidural patient-controlled analgesia will be used in the postoperative period. If spinal anesthesia and PENG block is applied, intravenous morphine patient-controlled analgesia will be used in the postoperative period.

Procedure: Regional anesthesia with neuroaxial blockage

Interventions

General anesthesia with propofol induction and sevoflurane maintenance PROCEDURE

Surgical procedure is performed under general anesthesia with propofol induction and mainteined with sevoflurane inhalation.

General anesthesia group

Regional anesthesia with neuroaxial blockage PROCEDURE

Surgical procedure is performed under regional anesthesia. Patients are sedated with 2 mg intravenous midazolam. Combined spinal epidural anesthesia or spinal anesthesia with PENG block is used for anesthesia and analgesia.

Regional anesthesia 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:

• Planning of total hip arthroplasty (primary/redo)
• Elective procedure planning
• years and older patients
• ASA score between I-III
• Approved and signed the informed consent form

You may not qualify if:

• Patients who underwent THA with urgent indication
• 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)

Bursa Uludağ University Faculty of Medicine

Bursa, Nilüfer, 16059, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parasomnias; Postoperative Complications

Interventions

Anesthesia, General; Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator completing the questionnaires will not be aware of patient group assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: August 30, 2023
• First Posted: September 18, 2023
• Study Start: July 21, 2022
• Primary Completion: August 5, 2023
• Study Completion: October 28, 2023
• Last Updated: February 14, 2024

Record last verified: 2023-09

Locations

TU (1)