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History of Changes for Study: NCT05341375
Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery
Latest version (submitted April 30, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 21, 2022 None (earliest Version on record)
2 April 30, 2022 Recruitment Status, Study Status, Contacts/Locations, Study Design and Study Description
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Study NCT05341375
Submitted Date:  April 21, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 201450450
Brief Title: Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery
Official Title: Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2022
Overall Status: Recruiting
Study Start: April 6, 2021
Primary Completion: January 27, 2022 [Actual]
Study Completion: May 1, 2022 [Anticipated]
First Submitted: April 3, 2022
First Submitted that
Met QC Criteria:
April 21, 2022
First Posted: April 22, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
April 21, 2022
Last Update Posted: April 22, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: The First Hospital of Qinhuangdao
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: To investigate the effect of ultrasound-guided thoracic paravertebral nerve block combined with intraoperative infusion of s-ketamine on postoperative acute pain and cognitive function in patients with thoracoscopic surgery
Detailed Description: A total of 120 patients who were admitted to Qinhuangdao First Hospital for and divided into control group (group C ), thoracic paravertebral nerve block combined with full Anesthesia group (group TA), thoracic paravertebral nerve block combined with intraoperative infusion of s-ketamine group ( group TE). 40 cases in each group. Group C received general anesthesia, group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction, and group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation. The MAP(Mean Artery Pressure) and HR(Heart Rate) of the three groups were recorded before surgery (T1), during the surgery (T2), immediately after surgery (T3). Compare the VAS(Visual analogue scale)in the ten minnues after extubation and one day afte surgery .The cognitive function of the three groups were evaluated by the Mini Mental State Scale (MMSE) on one day before surgery , one day after surgery , and three months after surgery . Compare the incidence of POCD among the three groups.
Open or close this module Conditions
Conditions: Postoperative Cognitive Dysfunction
Keywords: Esketamine
Thoracic paravertebral block
Cognitive function
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Crossover Assignment
Number of Arms: 4
Masking: Double (Participant, Care Provider)
Allocation: Randomized
Enrollment: 120 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Group C
The general anesthesia was used.In this group, cognitive function was evaluated by MMSE scale on one day before surgery, one day after surgery, and three months after surgery
Behavioral: Measurement of cognitive function
Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery
Other Names:
  • assessment of POCD
Experimental: Group TA
Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction
Procedure: Thoracic paravertebral block
The patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3cm 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
Other Names:
  • General anesthesia
Behavioral: Measurement of cognitive function
Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery
Other Names:
  • assessment of POCD
Experimental: Group TE
Group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation
Procedure: Thoracic paravertebral block
The patient was placed in lateral supine position, and the T5 spinous process was moved 2 to 3cm 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
Other Names:
  • General anesthesia
Drug: Esketamine
Group TE received s-ketamine anesthesia induction dose of 0.3 mg/kg on the basis of TA group. Anesthesia maintenance dose of 0.2ug/kg/h was pumped to 30min before the end of the operation
Other Names:
  • Combined general anesthesia
Behavioral: Measurement of cognitive function
Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery
Other Names:
  • assessment of POCD
Non-surgical controls
Age and sex-matched community people are included for three sessions of MMSE test evaluation for calculation of POCD incidence as normal control to in Z value calculation of POCD incidence to rule out learning effect
Behavioral: The assessment of cognitive function
Participants were assessed for MMSE at the same period as the group C
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of POCD at one day after surgery
[ Time Frame: One day after surgery ]

The MMSE 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 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
2. Incidence of POCD at three months after surgery
[ Time Frame: Three months after surgery ]

The MMSE 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
3. Change in pain assessed by Visual Analogue Scale
[ Time Frame: Ten minutes after extubation ]

Divide the ruler into 10 equal parts, with 0-2 indicating no pain, 3-5 indicating mild pain, 6-8 indicating moderate pain, and 9-10 indicating severe pain.
4. Change in pain assessed by Visual Analogue Scale
[ Time Frame: One day after surgery ]

Divide the ruler into 10 equal parts, with 0-2 indicating no pain, 3-5 indicating mild pain, 6-8 indicating moderate pain, and 9-10 indicating severe pain.
Secondary Outcome Measures:
1. Anesthetic drug
[ Time Frame: during the surgery ]

The dosage of remifentanil and propofol in different groups were recorded
2. The change of MAP
[ Time Frame: pre-surgery;during the surgery;immediately after surgery ]

The change of Mean Arterial Pressure(MAP) among the three groups
3. The change of HR
[ Time Frame: pre-surgery;during the surgery;immediately after surgery ]

The change of Heart Rate(HR) among the three groups
Open or close this module Eligibility
Minimum Age: 45 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • 18-24kg/m2
  • American Society of Anesthesiologists (ASA) grades I-III
  • The score of Mini Mental state examination≥24

Exclusion Criteria:

  • Patients with heart, lung and other vital organ disorders
  • The score of Mini Mental state examination≤23
  • 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
  • Refuse to sign informed consent
Open or close this module Contacts/Locations
Central Contact Person: qiximing qiximing, doctor
Telephone: 13731777660
Email: qhdddyyykyc@163.com
Study Officials: PI liuqinshuang, master
Study Director
The First hosptial of Qinhuangdao
chenxiaodan chenxiaodan, master
Study Chair
The First hosptial of Qinhuangdao
Locations: China
The First hosptial of Qinhuangdao
[Recruiting]
Qinhuangdao, China
Contact:Contact: qiximing
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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