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Clinical Trials/NCT05341375
NCT05341375
Completed
N/A

Effects of Thoracic Paravertebral Block Combined With S-ketamine on Postoperative Pain and Cognitive Function After Thoracoscopic Surgery

The First Hospital of Qinhuangdao1 site in 1 country110 target enrollmentApril 6, 2021

Overview

Phase
N/A
Intervention
Measurement of cognitive function
Conditions
Postoperative Cognitive Dysfunction
Sponsor
The First Hospital of Qinhuangdao
Enrollment
110
Locations
1
Primary Endpoint
Change in pain assessed by Visual Analogue Scale
Status
Completed
Last Updated
3 years ago

Overview

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 minuses 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 Postoperative Cognitive Disfuntion( POCD) among the three groups.

Registry
clinicaltrials.gov
Start Date
April 6, 2021
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
The First Hospital of Qinhuangdao
Responsible Party
Sponsor

Eligibility 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

Arms & 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

Intervention: Measurement of cognitive function

Group TA

Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction

Intervention: Thoracic paravertebral block

Group TA

Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction

Intervention: Measurement of cognitive function

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

Intervention: Thoracic paravertebral block

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

Intervention: Esketamine

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

Intervention: Measurement of cognitive function

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

Intervention: The assessment of cognitive function

Outcomes

Primary Outcomes

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.

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

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

Secondary Outcomes

  • The change of MAP(pre-surgery;during the surgery;immediately after surgery)
  • The change of HR(pre-surgery;during the surgery;immediately after surgery)
  • Anesthetic drug(during the surgery)

Study Sites (1)

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