Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06541483
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Multicentre Clinical Study of Ultra-Fast-Track Anaesthesia for Minimally Invasive Heart Valve Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicenter Clinical Study of Ultra-Fast-Track Cardiac Anesthesia in Minimally Invasive Cardiac Surgery for Valvular Heart Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
The goal of this clinical trial is to evaluate the clinical effects of ultra-fast-track anesthesia UFTA for minimally invasive cardiac surgery MICS in adults It will also learn about the safety and feasibility of Ultra-Fast-Track cardiac surgeryUFTCAThe main questions it aims to answer areDoes UFTCA promote rapid postoperative recovery reduce postoperative complications and perioperative mortality and improve the quality of mid- and long-term survivalAnd does it improve patient satisfaction and reduce healthcare costs
Participants will receive homogenized perioperative management in the cardiac ward extracorporeal circulation and postoperative ICU except for anesthesia extubation timeFurthermoreParticipants need complete quality of life scales at 30 days 90 days six months and one year after surgery separately
Participants in this study are adults who required elective minimally invasive heart valve surgery under extracorporeal circulationThis study will be able to promote rapid recovery while reducing the associated costs and the financial burden on participantsRetrospective big data analysis of perioperative clinical characteristics of patients undergoing minimally invasive heart valve surgery to establish a risk warning model and develop a perioperative management program The investigators then conducts a randomized group trial comparing the similarities and differences between conventional general anesthesiaCGA and ultra-fast-track cardiac anesthesiaURTCA to demonstrate the effectiveness and safety of UFTA in MICSFinally building expert consensus
Participants will receive homogenized perioperative management in the cardiac ward extracorporeal circulation and postoperative ICU except for anesthesia extubation timeFurthermoreParticipants need complete quality of life scales at 30 days 90 days six months and one year after surgery separately
Participants in this study are adults who required elective minimally invasive heart valve surgery under extracorporeal circulationThis study will be able to promote rapid recovery while reducing the associated costs and the financial burden on participantsRetrospective big data analysis of perioperative clinical characteristics of patients undergoing minimally invasive heart valve surgery to establish a risk warning model and develop a perioperative management program The investigators then conducts a randomized group trial comparing the similarities and differences between conventional general anesthesiaCGA and ultra-fast-track cardiac anesthesiaURTCA to demonstrate the effectiveness and safety of UFTA in MICSFinally building expert consensus
Detailed Description:
This study was divided into two partsThe first part is retrospective data collection and organization screening risk factors to establish an early warning model to improve the perioperative management program and the other part is conducted using a randomized controlled trial to evaluate the effectiveness safety and benefit of the perioperative management program of ultra-fast-track anesthesiaUFTA for minimally invasive heart valve surgery The specific program is as follows
Part I
1 Establishment of an information collection platform Log in to the platform for electronic data entry and retain the paper version of the CaseReportFormCRF
2 Retrospective data collection Relying on the National Head Medical Center for Cardiac Surgery 5000 perioperative case data of minimally invasive heart valve surgery patients were counted to obtain the perioperative clinical characteristics of Chinese adult minimally invasive heart valve surgery patients
3 Screening for risk factors Statistical analysis of risk factors affecting perioperative ultra-fast-track anesthesia delivery and postoperative complications
4 Establishment of early warning model Combining age stratification surgical mode stratification and general characteristics establish an early warning model to improve the perioperative management protocol of ultra-fast channel anesthesia for minimally invasive heart valve surgery
Part II Recruitment of participants for a prospective randomized controlled trial
1 Participants Patients undergoing elective minimally invasive adult heart valve surgery will be selected after completion of history taking physical examination preoperative laboratory and ancillary investigations preoperative health and quality of life questionnaires and frailty assessment of their physical condition and will be confirmed to be free of any one of the Exclusion Criteria and to meet any one or more of the Inclusion Criteria Those who fulfill any one of the Exclusion Criteria and more than one of the Inclusion Criteria will be given a screening number After completing the basic information and preoperative medications the participant signed the informed consent form If either the participant or the family member does not agree to participate in the study the participant will only be given a screening number and the study will end here
2 Randomized grouping Participants who were included to meet the criteria were randomly divided into the ultra-fast-track anesthesia group UFTCA and the conventional general anesthesia group CGA and the homogenized perioperative management of the extracardiac ward extracorporeal circulation and postoperative ICU was implemented except for anesthesia resuscitation methods
3 Anesthesia management 31 Preoperative Preoperative education nutritional support fasting and abstinence from food and drink prophylactic multimodal analgesia preoperative oral pregabalin 150 mg and acetaminophen 1000 mg 32 Intraoperative Anesthesia mode tracheal intubation general anesthesia plus nerve block anesthesia Induction of anesthesia intravenous slow push etomidate fat milk injection 015 mgkg propofol injection 0510 mgkg sufentanil citrate injection 0405 mgkg rocuronium bromide 0608 mgkg to be the patients consciousness disappeared to be the mask pressurized denitrification of oxygen for 35 minutes muscle relaxation after the complete effect of the laryngoscopy under the direct visualization The patient was intubated fixed and mechanically ventilated and the respiratory parameters were set as follows Fraction of inspiratory oxygen concentration FiO2 5080 tidal volume VT 68 mlkg respiratory rate RR 1012 timesmin Inhalation-exhalation ratio IE 12 Maintain End-tidal CarbonDioxidePartialPressure PetCO2 at 3545 mmHg
Anesthesia maintenance Propofol injection 150250 μgkgmin and remifentanil 0204 μgkgmin were continuously pumped through the central venous catheter and intraoperative EEG Bispectral Index BIS values were maintained between 4060
According to the hemodynamic indexes respiratory parameters and the needs of surgical operation intravenous sufentanil was injected in divided doses of 0102 μgkg and the total amount of intraoperative sufentanil was controlled to be 1015 μgkg
Additional rocuronium bromide 0102 mgkg was added at the time of aortic blockade and opening respectively
Intraoperative multimodal analgesia Pectoral nerves IPecs I Pectoral nerves IIPecs II anterior serratus plane blockSPB anesthetic resuscitation Evaluate to confirm whether the patient can be included in ultra-fast-track anesthesia
After the aorta was opened the anesthesiologist by observing the surgical procedure and communicating with the surgeon as well as the sonographer in a timely manner confirmed that the surgery was successful the heart was restarting normally the extracorporeal circulation was withdrawn smoothly there was no active hemorrhage in the surgical field hemostasis was complete oxygenation was functioning well and the patients finger pulse oximetry saturation was 98 under conditions of inhaled pure oxygen
UFTCAThe amount of propofol maintenance was dynamically adjusted according to the degree of stimulation at the beginning of chest closure and all intravenous anesthesia maintenance drugs were discontinued at the beginning of chest closure When the patient is under deep anesthesia clear the patients airway secretions and other foreign objects in advance without interfering with the surgeons operation give bilateral lung bulging and according to the trend of the BIS value and the patients somatic reaction or not give a single intravenous injection of propofol of 2030mg as appropriate to maintain the patients sedation until the end of the operation and then remove the airway catheter when the patient is fully awake on the operating table If necessary an appropriate amount of neostigmine methylsulfate 1mg and atropine sulfate injection 05mg can be used intravenously to antagonize the muscle relaxant
CGAPropofol injection 150250 μgkgmin and remifentanil 0204 ugkgmin were continuously pumped and the patients were transferred to the ICU with tubes and the ICU doctors decided the timing of stopping sedation and extubation
33 Postoperative multimodal analgesia Immediately after surgery an intravenous analgesic pump was connected sufentanil 200 μg and palonosetron 025 mg saline configured to a total of 200 mL
4 Surgery Valve surgery encompasses aortic valve mitral valve tricuspid valve disease performing single double triple valves using minimally invasive proceduresThis can be done through a small upper sternal incision a small right anterior chest incision or a small transaxillary incision
5 Extracorporeal circulation management The pre-filled fluid for extracorporeal circulation was 500750 ml of crystalloid 150 ml of 20 mannitol 100 ml of 20 albumin and 150 ml of sodium bicarbonate
Heparinization was performed at 34 mgkg and extracorporeal circulation was started after activated clotting timeACT480s The pacing fluid and dosage was 30 mlkg and the total amount did not exceed 2000 ml
During extracorporeal circulation the mean arterial pressure was maintained at 5080 mmHg and the perfusion flow rate was 2224 Lm2
6 Postoperative monitoring The Visual Analogue Score VAS was used for pain assessment after tracheal tube removal VAS pain score by the nurse every 4 hours if VAS 3 then press the analgesic pump once additional sufentanil 3 5 μg 3 minutes later to assess again if the patient VAS 3 then press the analgesic pump again additional sufentanil 3 5 μg if sufentanil reached the analgesic pump set the limit of the amount of VAS 3 or produce serious nausea and vomiting and other side effects then the intravenous oxycodone 10mg time for Remedial analgesia
Part I
1 Establishment of an information collection platform Log in to the platform for electronic data entry and retain the paper version of the CaseReportFormCRF
2 Retrospective data collection Relying on the National Head Medical Center for Cardiac Surgery 5000 perioperative case data of minimally invasive heart valve surgery patients were counted to obtain the perioperative clinical characteristics of Chinese adult minimally invasive heart valve surgery patients
3 Screening for risk factors Statistical analysis of risk factors affecting perioperative ultra-fast-track anesthesia delivery and postoperative complications
4 Establishment of early warning model Combining age stratification surgical mode stratification and general characteristics establish an early warning model to improve the perioperative management protocol of ultra-fast channel anesthesia for minimally invasive heart valve surgery
Part II Recruitment of participants for a prospective randomized controlled trial
1 Participants Patients undergoing elective minimally invasive adult heart valve surgery will be selected after completion of history taking physical examination preoperative laboratory and ancillary investigations preoperative health and quality of life questionnaires and frailty assessment of their physical condition and will be confirmed to be free of any one of the Exclusion Criteria and to meet any one or more of the Inclusion Criteria Those who fulfill any one of the Exclusion Criteria and more than one of the Inclusion Criteria will be given a screening number After completing the basic information and preoperative medications the participant signed the informed consent form If either the participant or the family member does not agree to participate in the study the participant will only be given a screening number and the study will end here
2 Randomized grouping Participants who were included to meet the criteria were randomly divided into the ultra-fast-track anesthesia group UFTCA and the conventional general anesthesia group CGA and the homogenized perioperative management of the extracardiac ward extracorporeal circulation and postoperative ICU was implemented except for anesthesia resuscitation methods
3 Anesthesia management 31 Preoperative Preoperative education nutritional support fasting and abstinence from food and drink prophylactic multimodal analgesia preoperative oral pregabalin 150 mg and acetaminophen 1000 mg 32 Intraoperative Anesthesia mode tracheal intubation general anesthesia plus nerve block anesthesia Induction of anesthesia intravenous slow push etomidate fat milk injection 015 mgkg propofol injection 0510 mgkg sufentanil citrate injection 0405 mgkg rocuronium bromide 0608 mgkg to be the patients consciousness disappeared to be the mask pressurized denitrification of oxygen for 35 minutes muscle relaxation after the complete effect of the laryngoscopy under the direct visualization The patient was intubated fixed and mechanically ventilated and the respiratory parameters were set as follows Fraction of inspiratory oxygen concentration FiO2 5080 tidal volume VT 68 mlkg respiratory rate RR 1012 timesmin Inhalation-exhalation ratio IE 12 Maintain End-tidal CarbonDioxidePartialPressure PetCO2 at 3545 mmHg
Anesthesia maintenance Propofol injection 150250 μgkgmin and remifentanil 0204 μgkgmin were continuously pumped through the central venous catheter and intraoperative EEG Bispectral Index BIS values were maintained between 4060
According to the hemodynamic indexes respiratory parameters and the needs of surgical operation intravenous sufentanil was injected in divided doses of 0102 μgkg and the total amount of intraoperative sufentanil was controlled to be 1015 μgkg
Additional rocuronium bromide 0102 mgkg was added at the time of aortic blockade and opening respectively
Intraoperative multimodal analgesia Pectoral nerves IPecs I Pectoral nerves IIPecs II anterior serratus plane blockSPB anesthetic resuscitation Evaluate to confirm whether the patient can be included in ultra-fast-track anesthesia
After the aorta was opened the anesthesiologist by observing the surgical procedure and communicating with the surgeon as well as the sonographer in a timely manner confirmed that the surgery was successful the heart was restarting normally the extracorporeal circulation was withdrawn smoothly there was no active hemorrhage in the surgical field hemostasis was complete oxygenation was functioning well and the patients finger pulse oximetry saturation was 98 under conditions of inhaled pure oxygen
UFTCAThe amount of propofol maintenance was dynamically adjusted according to the degree of stimulation at the beginning of chest closure and all intravenous anesthesia maintenance drugs were discontinued at the beginning of chest closure When the patient is under deep anesthesia clear the patients airway secretions and other foreign objects in advance without interfering with the surgeons operation give bilateral lung bulging and according to the trend of the BIS value and the patients somatic reaction or not give a single intravenous injection of propofol of 2030mg as appropriate to maintain the patients sedation until the end of the operation and then remove the airway catheter when the patient is fully awake on the operating table If necessary an appropriate amount of neostigmine methylsulfate 1mg and atropine sulfate injection 05mg can be used intravenously to antagonize the muscle relaxant
CGAPropofol injection 150250 μgkgmin and remifentanil 0204 ugkgmin were continuously pumped and the patients were transferred to the ICU with tubes and the ICU doctors decided the timing of stopping sedation and extubation
33 Postoperative multimodal analgesia Immediately after surgery an intravenous analgesic pump was connected sufentanil 200 μg and palonosetron 025 mg saline configured to a total of 200 mL
4 Surgery Valve surgery encompasses aortic valve mitral valve tricuspid valve disease performing single double triple valves using minimally invasive proceduresThis can be done through a small upper sternal incision a small right anterior chest incision or a small transaxillary incision
5 Extracorporeal circulation management The pre-filled fluid for extracorporeal circulation was 500750 ml of crystalloid 150 ml of 20 mannitol 100 ml of 20 albumin and 150 ml of sodium bicarbonate
Heparinization was performed at 34 mgkg and extracorporeal circulation was started after activated clotting timeACT480s The pacing fluid and dosage was 30 mlkg and the total amount did not exceed 2000 ml
During extracorporeal circulation the mean arterial pressure was maintained at 5080 mmHg and the perfusion flow rate was 2224 Lm2
6 Postoperative monitoring The Visual Analogue Score VAS was used for pain assessment after tracheal tube removal VAS pain score by the nurse every 4 hours if VAS 3 then press the analgesic pump once additional sufentanil 3 5 μg 3 minutes later to assess again if the patient VAS 3 then press the analgesic pump again additional sufentanil 3 5 μg if sufentanil reached the analgesic pump set the limit of the amount of VAS 3 or produce serious nausea and vomiting and other side effects then the intravenous oxycodone 10mg time for Remedial analgesia
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