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

Postoperative Cognitive Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05341375
• Other study ID #: 201450450
• Status: Completed
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: April 2022
• Source: The First Hospital of Qinhuangdao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 30, 2022
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Pain, Postoperative
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Intervention

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

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

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
• The assessment of cognitive function
Participants were assessed for MMSE at the same period as the group C

Locations

Country	Name	City	State
China	The First hosptial of Qinhuangdao	Qinhuangdao

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 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	One day after surgery
Primary	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	Three months after surgery
Primary	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.	Ten minutes after extubation
Primary	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.	One day after surgery
Secondary	Anesthetic drug	The dosage of remifentanil and propofol in different groups were recorded	during the surgery
Secondary	The change of MAP	The change of Mean Arterial Pressure(MAP) among the three groups	pre-surgery;during the surgery;immediately after surgery
Secondary	The change of HR	The change of Heart Rate(HR) among the three groups	pre-surgery;during the surgery;immediately after surgery