Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06633432
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Postoperative Sleep Quality and Pain of Patients After Video-Assisted Thoracoscopic Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSQ
Brief Summary:
The goal of this clinical trial is to to explore the effect of perioperative transcutaneous acupoint acupuncture and moxibustion stimulation on sleep quality and postoperative chronic pain in patients undergoing thoracoscopic assisted radical resection of lung cancer and explore its potential mechanism This clinical trial focus on the following questions
Whether perioperative transcutaneous acupoint acupuncture and moxibustion stimulation reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain What medical problems do participants have when taking acupuncture Researchers will compare acupuncture to sham acupuncture Non transdermal comfort needles can cause patients to experience a needle like sensation similar to when the needle is inserted into the skin but in reality it does not break the skin to see if acupuncture works to reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain
Participants will
Take acupuncture or a sham acupuncture every day for 3 daysthe night before surgery the night of surgery and the first night after surgery
On the day before surgery the first day after surgery the second day after surgery and the day before discharge the sleep status should be continuously monitored using a sleep monitoring screening device ZG-S01D The incidence of pain is determined by whether there is pain including all discomfort during patient follow-up
Whether perioperative transcutaneous acupoint acupuncture and moxibustion stimulation reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain What medical problems do participants have when taking acupuncture Researchers will compare acupuncture to sham acupuncture Non transdermal comfort needles can cause patients to experience a needle like sensation similar to when the needle is inserted into the skin but in reality it does not break the skin to see if acupuncture works to reduce the incidence of Postoperative Sleep Disorder and postoperative acute and chronic pain
Participants will
Take acupuncture or a sham acupuncture every day for 3 daysthe night before surgery the night of surgery and the first night after surgery
On the day before surgery the first day after surgery the second day after surgery and the day before discharge the sleep status should be continuously monitored using a sleep monitoring screening device ZG-S01D The incidence of pain is determined by whether there is pain including all discomfort during patient follow-up
Detailed Description:
This experiment is divided into two groups the experimental group and the control group If you participate in the experiment you will be randomly assigned to two groups with a 50 probability of entering the experimental group and a 50 probability of entering the control group
Research steps Anesthesia process i Preoperative preparation Complete the scoring form continuous dynamic blood pressure monitoring and continuous electrocardiogram monitoring 24 hours before surgery All patients were fasted and deprived of water for 8 hours before surgery The upper limb venous access was opened in the pre anesthesia room Bupivacaine liposomes were used to block the intercostal nerves in 4 intercostal spaces above and below the incision and invasive anesthesia was performed around the surgical incision and drainage tube placement Supplement sodium lactate Ringer solution according to the preoperative loss amount Confirm the informed consent status again
After entering the room routine electrocardiographic monitoring ECG non-invasive arterial blood pressure NIBP oxygen saturation SpO2 and mask oxygen inhalation were performed
ii Anesthesia induction and maintenance Anesthesia induction Inject sufentanil 04ugkg and propofol 15-2mgml intravenously in sequence After the patients consciousness disappears inject rocuronium 06mgkg intravenously insert a double lumen bronchial tube F35-37 and locate with a fiberoptic bronchoscope
Anesthesia maintenance maintained by inhalation of sevoflurane intraoperative detection of end tidal sevoflurane MAC value maintained at 10-12MAC Administer sufentanil and rocuronium bromide intravenously as needed during surgery
Anesthesia recovery The patient is transferred to the post anesthesia care unit PACU after conscious extubation and then transferred to the ward to ensure complete consciousness The Aldrete score is 9
Treatment and follow-up process i The acupuncture group administered medication three times at each acupoint 1 the night before surgery 2 the night of surgery and 3 the first night after surgery Acupuncture and moxibustion stimulation is applied to four pairs of acupoints bilateral Shenmen HT7 Neiguan PC6 Zusanli ST36 and Zhaohai KI6 which are selected according to the previous systematic review and the summary of clinical experience The pillow used is a disposable sterile stainless steel needle with a length of 40mm and a diameter of 025mm In the acupuncture group the acupuncture and moxibustion successively acupunctured four points with a depth of 10-20mm Select the specific depth based on the subjects body type tall short fat thin After the puncture the acupuncture and moxibustion lifted and twisted the needle handle and then retained the needle for 20 minutes The sham acupuncture group received non skin breaking comfort needles at corresponding points for acupuncture and moxibustion the night before the operation the night of the operation and the first night after the operation and kept the needles for 20 minutes Non transdermal comfort needles can cause patients to experience a needle like sensation similar to piercing the skin but in reality they do not break the skin Before each application of acupuncture it is necessary to evaluate whether the patient can perform acupuncture and moxibustion and whether there is a history of fainting If there is a history of needle dizziness the trial must be withdrawn
ii On the day before surgery the first day after surgery the second day and the day before discharge the sleep status should be continuously monitored using a sleep monitoring screening device ZG-S01D
iii The degree of postoperative acute pain mainly includes the pain during rest activity and coughing on the first to seventh day after surgery or during hospitalization when hospitalization days are less than 7 days The evaluation time point is twice a day 9am and 3pm on postoperative days 1-2 From the 3rd to the 7th day after surgery once a day 9am Pain description and the impact of pain on body function should be evaluated once on the 7th day after surgery or discharge day In addition on the first day after surgery at 9am patients were also asked to recall the most severe resting pain level after surgery The degree of pain within 24 hours after surgery 1 hour 4 hours 8 hours and 16 hours is indirectly reflected by heart rate blood pressure and blood oxygen saturation medical record review The severity of postoperative acute pain in patients is mainly obtained by researchers through face-to-face pain assessment with the assistance of nurses if necessary
iiii Postoperative chronic pain CPSP of patients and pain during follow-up include four aspects pain incidence pain description pain severity and the impact of pain on body function The evaluation is mainly conducted by researchers through telephone follow-up with evaluation times of 2 weeks 1 month 2 months 3 months and 6 months after surgery respectively The pain followed up at 3 months after surgery is postoperative chronic pain
If you agree to participate in this study please sign this informed consent form During the entire study period it is planned to collect 5 additional blood samples each containing 5ml with a total volume of approximately 25ml for the determination of serum levels of IL-1 IL-6 TNF - α plasma levels of 5-HT DA NE and melatonin
Research steps Anesthesia process i Preoperative preparation Complete the scoring form continuous dynamic blood pressure monitoring and continuous electrocardiogram monitoring 24 hours before surgery All patients were fasted and deprived of water for 8 hours before surgery The upper limb venous access was opened in the pre anesthesia room Bupivacaine liposomes were used to block the intercostal nerves in 4 intercostal spaces above and below the incision and invasive anesthesia was performed around the surgical incision and drainage tube placement Supplement sodium lactate Ringer solution according to the preoperative loss amount Confirm the informed consent status again
After entering the room routine electrocardiographic monitoring ECG non-invasive arterial blood pressure NIBP oxygen saturation SpO2 and mask oxygen inhalation were performed
ii Anesthesia induction and maintenance Anesthesia induction Inject sufentanil 04ugkg and propofol 15-2mgml intravenously in sequence After the patients consciousness disappears inject rocuronium 06mgkg intravenously insert a double lumen bronchial tube F35-37 and locate with a fiberoptic bronchoscope
Anesthesia maintenance maintained by inhalation of sevoflurane intraoperative detection of end tidal sevoflurane MAC value maintained at 10-12MAC Administer sufentanil and rocuronium bromide intravenously as needed during surgery
Anesthesia recovery The patient is transferred to the post anesthesia care unit PACU after conscious extubation and then transferred to the ward to ensure complete consciousness The Aldrete score is 9
Treatment and follow-up process i The acupuncture group administered medication three times at each acupoint 1 the night before surgery 2 the night of surgery and 3 the first night after surgery Acupuncture and moxibustion stimulation is applied to four pairs of acupoints bilateral Shenmen HT7 Neiguan PC6 Zusanli ST36 and Zhaohai KI6 which are selected according to the previous systematic review and the summary of clinical experience The pillow used is a disposable sterile stainless steel needle with a length of 40mm and a diameter of 025mm In the acupuncture group the acupuncture and moxibustion successively acupunctured four points with a depth of 10-20mm Select the specific depth based on the subjects body type tall short fat thin After the puncture the acupuncture and moxibustion lifted and twisted the needle handle and then retained the needle for 20 minutes The sham acupuncture group received non skin breaking comfort needles at corresponding points for acupuncture and moxibustion the night before the operation the night of the operation and the first night after the operation and kept the needles for 20 minutes Non transdermal comfort needles can cause patients to experience a needle like sensation similar to piercing the skin but in reality they do not break the skin Before each application of acupuncture it is necessary to evaluate whether the patient can perform acupuncture and moxibustion and whether there is a history of fainting If there is a history of needle dizziness the trial must be withdrawn
ii On the day before surgery the first day after surgery the second day and the day before discharge the sleep status should be continuously monitored using a sleep monitoring screening device ZG-S01D
iii The degree of postoperative acute pain mainly includes the pain during rest activity and coughing on the first to seventh day after surgery or during hospitalization when hospitalization days are less than 7 days The evaluation time point is twice a day 9am and 3pm on postoperative days 1-2 From the 3rd to the 7th day after surgery once a day 9am Pain description and the impact of pain on body function should be evaluated once on the 7th day after surgery or discharge day In addition on the first day after surgery at 9am patients were also asked to recall the most severe resting pain level after surgery The degree of pain within 24 hours after surgery 1 hour 4 hours 8 hours and 16 hours is indirectly reflected by heart rate blood pressure and blood oxygen saturation medical record review The severity of postoperative acute pain in patients is mainly obtained by researchers through face-to-face pain assessment with the assistance of nurses if necessary
iiii Postoperative chronic pain CPSP of patients and pain during follow-up include four aspects pain incidence pain description pain severity and the impact of pain on body function The evaluation is mainly conducted by researchers through telephone follow-up with evaluation times of 2 weeks 1 month 2 months 3 months and 6 months after surgery respectively The pain followed up at 3 months after surgery is postoperative chronic pain
If you agree to participate in this study please sign this informed consent form During the entire study period it is planned to collect 5 additional blood samples each containing 5ml with a total volume of approximately 25ml for the determination of serum levels of IL-1 IL-6 TNF - α plasma levels of 5-HT DA NE and melatonin
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None