Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2023
Source The First Hospital of Qinhuangdao
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

A total of 92 patients who were admitted to Qinhuangdao First Hospital for and divided into control group (group C ), thoracic paravertebral nerve block combined with general anesthesia group (group T). Group C received general anesthesia, and group T received 0.375% ropivacaine 20 ml of thoracic paravertebral nerve block combined with general anesthesia after induction of anesthesia. SBP(Systolic Blood Pressure)/DBP (Diastolic Pressure)and HR(Heart Rate) of the two groups were recorded before anesthesia induction (T1), at the time of intubation (T2), at the beginning of surgery (T5), immediately after surgery (T6), and five minutes after extubation (T7) . rScO2(Regional cerebral oxygen saturation) was recorded in both groups at (T1), five minutes after induction(T3), five minutes after single lung ventilation on lateral recumbent(T4), (T6), (T7). The incidence of acute and chronic pain after surgery was compared between the two groups by NRS(Numerical Rating Scale)after extubation , one day after surgery, and three months after surgery. The cognitive function of the two groups was assessed with the Mini Mental State Scale (MMSE) and the Montreal Cognitive Assessment Scale (MoCA-Beijing) on the day before , one day after and three months after surgery, comparing the incidence of PND (postoperative cognitive dysfunction) between the two groups.Analyze whether paravertebral block can reduce the incidence of POD by improving brain oxygen saturation.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Measurement of cognitive function
Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE and MoCA were assessed at one day before surgery, one day after surgery, and three months after surgery
Procedure:
Thoracic paravertebral block
The patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3 cm laterally to the operative side as the puncture point, and the pleura and T5 transverse process were observed, and the paraspinal space was observed on the lower lateral side of the transverse process. Using in-plane technique, the needle position was adjusted under ultrasound visualization to reach the paraspinal space. 20ml 0.375% ropivacaine was injected into the suction syringe when there was no blood or gas, and the drug liquid could be seen spreading outside the pleura. "Landscape sign" appeared, indicating successful block
Behavioral:
The assessment of cognitive function
Participants were assessed for MMSE and MoCA at the same period as the group C

Locations

Country Name City State
China The First hosptial of Qinhuangdao Qinhuangdao Hebei

Sponsors (1)

Lead Sponsor Collaborator
The First Hospital of Qinhuangdao

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05990790 - The Effect of Desflurane Versus Sevoflurane Versus Propofol on Postoperative Delirium Phase 4
Terminated NCT03337282 - Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
Active, not recruiting NCT02965235 - Correlations of Epigenetic Changes With POCD in Surgical Patients N/A
Not yet recruiting NCT02224443 - Effects of Different Doses of Dexmedetomidine on Postoperative Cognitive Dysfunction in Elderly Hypertensive Patients Phase 4
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Terminated NCT00991328 - Role of Absolute Cerebral Oximetry to Prevent Neurocognitive Injury in Elderly Patients Undergoing Cardiac Surgery Phase 3
Terminated NCT00757913 - n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery Phase 4
Terminated NCT00455143 - Cognitive Protection - Dexmedetomidine and Cognitive Reserve Phase 4
Recruiting NCT06176144 - Impact of Desflurane and Sevoflurane on Postoperative Delirium in Elderly Patients N/A
Completed NCT03620968 - Implementation of a Cognitive Training Program to Reduce the Risk of Postoperative Cognitive Dysfunction N/A
Completed NCT04701801 - Correlation of Preoperative Anxiety With Early Postoperative Cognitive Dysfunction in Breast Cancer Patients
Not yet recruiting NCT06469515 - Older People's Neurocognitive Recovery After Cardiac Surgery
Completed NCT02931877 - Comparison of Postoperative Outcome After Sevoflurane and Propofol Anaesthesia Phase 4
Not yet recruiting NCT02909413 - Comparison of Desflurane With Sevoflurane for School-age Children in Postoperative Cognitive Function N/A
Completed NCT02650687 - Optimizing Postoperative Cognition the Elderly
Not yet recruiting NCT01622452 - Post Cardiac Surgery Neurocognitive Decline: Correlations Between Neuropsychological Tests and Functional MRI Techniques N/A
Completed NCT01103752 - Postoperative Cognitive Dysfunction After Total Knee or Hip Replacement Surgery in Fast-track Set-up N/A
Completed NCT04312516 - Greek Validation of ACE III Test in Perioperative Patients
Not yet recruiting NCT05668559 - Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders N/A
Not yet recruiting NCT05439707 - Effects of Perioperative Transauricular Vagus Nerve Electrical Stimulation on POD, POCD and CPSP N/A