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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06269328
Other study ID # 2011-KAEK-26/463
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2022
Est. completion date January 1, 2024

Study information

Verified date July 2022
Source Uludag University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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Study Design


Intervention

Other:
Total intravenous anesthesia with propofol and remifentanil for anesthetic maintenance
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.
Inhalation anesthesia with sevoflurane for anesthetic maintenance
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% )

Locations

Country Name City State
Turkey Elifgül Ulutas Bursa Nilüfer

Sponsors (1)

Lead Sponsor Collaborator
Uludag University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Subjective anxiety level Anxiety level evaluated by STAI (The State Trait Anxiety Inventory), a scale provides ranging from 20 to 80, with a high score indicating high levels of anxiety. Preoperative status a month before surgery and a day before surgery and one week postoperatively]
Secondary Subjective pain level Pain level evaluated by VAS (Visuel analog scale) , a scale provides ranging from 0 to 10, with a high score indicating high levels of pain. Preoperative status a month before surgery and a day before surgery and one week postoperatively]
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