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

Primary Purpose

Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thoracic paravertebral block
Esketamine
Measurement of cognitive function
The assessment of cognitive function
Sponsored by
The First Hospital of Qinhuangdao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Cognitive Dysfunction focused on measuring Esketamine, Thoracic paravertebral block, Cognitive function

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The First hosptial of Qinhuangdao

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Other

Arm Label

Group C

Group TA

Group TE

Non-surgical controls

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Incidence of POCD at 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
Incidence of POCD at 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
Change in pain assessed by Visual Analogue Scale
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.
Change in pain assessed by Visual Analogue Scale
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

Anesthetic drug
The dosage of remifentanil and propofol in different groups were recorded
The change of MAP
The change of Mean Arterial Pressure(MAP) among the three groups
The change of HR
The change of Heart Rate(HR) among the three groups

Full Information

First Posted
April 3, 2022
Last Updated
April 30, 2022
Sponsor
The First Hospital of Qinhuangdao
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1. Study Identification

Unique Protocol Identification Number
NCT05341375
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
January 27, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Qinhuangdao

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Cognitive Dysfunction
Keywords
Esketamine, Thoracic paravertebral block, Cognitive function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Other
Arm Description
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
Arm Title
Group TA
Arm Type
Experimental
Arm Description
Group TA received 0.375% ropivacaine 20ml thoracic paravertebral nerve block combined with general anesthesia under ultrasound guidance after anesthesia induction
Arm Title
Group TE
Arm Type
Experimental
Arm Description
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
Arm Title
Non-surgical controls
Arm Type
Other
Arm Description
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 Type
Procedure
Intervention Name(s)
Thoracic paravertebral block
Other Intervention Name(s)
General anesthesia
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Esketamine
Other Intervention Name(s)
Combined general anesthesia
Intervention Description
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 Type
Behavioral
Intervention Name(s)
Measurement of cognitive function
Other Intervention Name(s)
assessment of POCD
Intervention Description
Patients undergoing thoracoscopic surgery underwent general anesthesia.MMSE was assessed at one day before surgery, one day after surgery, and three months after surgery
Intervention Type
Behavioral
Intervention Name(s)
The assessment of cognitive function
Intervention Description
Participants were assessed for MMSE at the same period as the group C
Primary Outcome Measure Information:
Title
Incidence of POCD at one day after surgery
Description
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
Time Frame
One day after surgery
Title
Incidence of POCD at three months after surgery
Description
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
Time Frame
Three months after surgery
Title
Change in pain assessed by Visual Analogue Scale
Description
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.
Time Frame
Ten minutes after extubation
Title
Change in pain assessed by Visual Analogue Scale
Description
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.
Time Frame
One day after surgery
Secondary Outcome Measure Information:
Title
Anesthetic drug
Description
The dosage of remifentanil and propofol in different groups were recorded
Time Frame
during the surgery
Title
The change of MAP
Description
The change of Mean Arterial Pressure(MAP) among the three groups
Time Frame
pre-surgery;during the surgery;immediately after surgery
Title
The change of HR
Description
The change of Heart Rate(HR) among the three groups
Time Frame
pre-surgery;during the surgery;immediately after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PI liuqinshuang, master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
chenxiaodan chenxiaodan, master
Organizational Affiliation
The First hosptial of Qinhuangdao
Official's Role
Study Chair
Facility Information:
Facility Name
The First hosptial of Qinhuangdao
City
Qinhuangdao
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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