Spinal Diseases
Conditions
Interventions
Group I:Use intelligent self-control analgesia pump after operation
Group T:Use traditional self-control analgesia pump after operation
Sponsors
Hong Hui Hospital, Xi'an Jiaotong University College of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: (1) Patients scheduled to be treated with 48h intravenous analgesia pump after posterior lumbar decompression and short-segment bone grafting and internal fixation under total intravenous anesthesia are selected; (2) American Society of Anesthesiologists (ASA) I or II; 18kg/?<BMI<30kg/?; (3) In-patients (18 to 64 years),male or female; (4) Fully understand and voluntarily participate in this clinical trial, and sign an informed consent.
Exclusion criteria
Exclusion criteria: 1.Six months before a new history of myocardial infarction or unstable angina, or more than II and II degrees atrioventricular block, such as severe arrhythmia history or NYHA heart function classification II level or above; 2.A history or current history of malignancy in the first five years (except for clinically stable squamous cell or basal cell carcinomas that have been thoroughly removed and treated); 3.Previous history of ischemic stroke or transient ischemic attack (TIA), symptomatic lacunar cerebral infarction, Parkinson's disease and other neurological diseases; 4.A history of difficult airway, or a history of difficult airway (such as obstructive sleep apnea syndrome) before surgery; 5.Previous history of digestive tract related diseases (e.g. reflux esophagitis); 6.Prior psychiatric disorders (e.g., schizophrenia, depression, etc.) and cognitive impairment, or a history of epilepsy; 7.Screening period random blood glucose > 11.1mmol/L; 8.Extended QTc interval: > 450ms for male and > 470ms for female (Fridericia method); 9.Subjects with no regular antihypertensive treatment or poor blood pressure control (sitting systolic blood pressure >= 160mmHg or >= 90mmHg during screening, and/or sitting diastolic blood pressure >= 100mmHg or = 1.5 x ULN and/or total bilirubin (TBIL) >= 1.5 x ULN; 12.Abnormal renal function: serum creatinine exceeds the upper limit of stock and/or dialysis subjects; 13.Coagulation abnormalities: PT prolongation exceeding the upper limit of normal for 3 seconds and/or APTT prolongation exceeding the upper limit of normal for 10 seconds, or prior history of deep vein thrombosis; 14.Tests were positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) syphilis, and human immunodeficiency virus (H) antibodies; 15.Positive for substance abuse screening; 16.Known allergies or contraindications to opioids and other drugs that may be used during the trial, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and antiemetic drugs; 17.Screening before using other drugs affecting the effects of analgesia use time is apart from the random shorter than five at the end of the half-life (the actual instruction shall prevail, the half-life is unknown, according to the 48 h elution), including but not limited to, monoamine oxidase inhibitors, hormone, opioid agonist/antagonist, sedative drugs except (according to the plan to use), nonsteroidal anti-inflammatory drugs (allowed aspirin for prevention of cardiovascular events, but should be stability using at least 30 days before the random, daily dose of 100 mg/day or less), CYP2D6, CYP3A4 and CYP3A5 inhibition/revulsant; 18.Subjects whose evaluation of the efficacy and safety of the test drug may be affected by alcohol, drug, or drug withdrawal during the study period; 19.Female subjects during pregnancy or lactation; 20.30 solstices before the screening period and within six months after the last use of the analgesia pump, family planning, unwillingness or inability to take adequate contraceptive measures; 21.Participate in clinical studies of other drugs or devices within three months before the screening period (sign an informed consent and accept
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total consumption of sufentanil in the PCA; | — |
Secondary
| Measure | Time frame |
|---|---|
| RVAS DVAS;observer's assessment of alertness/sedation, OAA/S;VAS;patients' satisfaction degree;Total consumption of dexmedetomidine in PCA;Adverse Effects Rate;Effective press times and total press times;ketorolac dosage;Vital signs (heart rate, respiratory rate, oxygen saturation); | — |
Countries
China
Contacts
Public ContactBuhuai Dong
Honghui Hospital, Xi'an Jiaotong University College of Medicine
Outcome results
None listed