Postoperative Cognitive Dysfunction Clinical Trial
Official title:
Effect of Thoracic Paravertebral Block on Chronic Pain and Cognitive Function After Thoracoscopic Partial Pulmonary Resection in Elderly Patients
NCT number | NCT05364216 |
Other study ID # | 20220503 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 12, 2022 |
Est. completion date | May 31, 2023 |
Verified date | July 2023 |
Source | The First Hospital of Qinhuangdao |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To investigate the effect of ultrasound-guided thoracic paravertebral nerve block on postoperative acute and chronic pain and cognitive function in elderly patients with thoracoscopic partial lung resection.
Status | Completed |
Enrollment | 92 |
Est. completion date | May 31, 2023 |
Est. primary completion date | February 28, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 90 Years |
Eligibility | Inclusion Criteria: - BMI less than 30 kg/m2 - American Society of Anesthesiologists (ASA) grades I-III - The score of Mini Mental state examination=24 - The score of Montreal Cognitive Assessment-Beijing Scale=26 Exclusion Criteria: - Patients with heart, lung, brain and other vital organ disorders - The score of Mini Mental state examination=23 - The score of Montreal Cognitive Assessment-Beijing Scale=25 - Preoperative psychiatric disorders or long-term use of drugs affecting the psychiatric system - Have severe visual, hearing, speech impairment or other inability to communicate with the visitor - Have contraindications to thoracic parathymic block - Refuse to sign informed consent |
Country | Name | City | State |
---|---|---|---|
China | The First hosptial of Qinhuangdao | Qinhuangdao | Hebei |
Lead Sponsor | Collaborator |
---|---|
The First Hospital of Qinhuangdao |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of POD at one day after surgery | The MMSE and MoCA difference between the patients on the day before surgery and one day after surgery was compared and substituted into the formula.The formula of Z-scoring method is Z= (XC-X) /SDXC, where X refers to the change value of patients' MMSE/MoCA score at one day before surgery and one day after surgery. XC is the mean change value of the non-surgical control group at the same time, and SDXC is the standard deviation of the change value of the non-surgical control group. Finally, the Z-value at one day after surgery is calculated respectively. If the value of Z is =1.96, the patient is considered to have developed POCD | One day after surgery | |
Primary | Incidence of POD at three months after surgery | The MMSE and MoCA difference between the patients on the day before surgery and three months after surgery was compared and substituted into the formula.The formula of Z-scoring method is Z= (XC-X) /SDXC, where X refers to the change value of patients' MMSE score at one day before surgery and three months after surgery. XC is the mean change value of the non-surgical control group at the same time, and SDXC is the standard deviation of the change value of the non-surgical control group. Finally, the Z-value at three months after surgery is calculated respectively. If the value of Z is =1.96, the patient is considered to have developed POCD | Three months after surgery | |
Primary | Change in pain assessed by Visual Analogue Scale | Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain,maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities,they strongly request the use of analgesics). | Five minutes after extubation | |
Primary | Change in pain assessed by Visual Analogue Scale | Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain,maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities,they strongly request the use of analgesics). | One day after surgery | |
Primary | Change in pain assessed by Visual Analogue Scale | Divide the ruler into 10 equal parts, with 0 means no pain, 1-3 indicating mild pain, 4-6 indicating moderate pain(Patients have mild restrictions on daily activities or mild sleep disturbances due to pain,maybe require additional analgesic treatment), and 7-10 indicating severe pain(Patients are unable to fall asleep and cannot perform daily activities,they strongly request the use of analgesics). | Three months after surgery | |
Secondary | The change of SBP/DP | The change of Systolic blood pressure(SBP) and Diastolic pressure(DP) among the two groups | before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation | |
Secondary | The change of HR | The change of Heart rate(HR) among the two groups | before anesthesia induction , at the time of intubation , at the beginning of surgery , immediately after surgery , and five minutes after extubation | |
Secondary | The change of rScO2, maximum and minimum of rScO2, duration of 10% below the base value | The change of regional cerebral oxygen saturation(rScO2), maximum and minimum of rScO2, duration of 10% below the base value among the two groups | before anesthesia induction , five minutes after induction, five minutes after single lung ventilation on lateral recumbent, immediately after surgery, and five minutes after extubation | |
Secondary | Anesthetic drug | The dosage of remifentanil and propofol in different groups were recorded | during the surgery |
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