Diseases requiring elective surgery under general anesthesia with an expected operative time of more than 30 minutes
Conditions
Interventions
Fospropofol Disodium (Part 1):In the first part, the biased coin sequential method was used to determine the 95% effective dose (ED95) and its 95% confidence interval of fospropofol disodium for gener
if unsuccessful, the dose is increased.
Propofol (Part 1):In the first part, the biased coin sequential method was used to determine the 95% effective dose (ED95) and its 95% confidence interval of propofol for general anesthesia induction
Fospropofol Disodium (Part 2):In the second part, with propofol as the control, the safety and efficacy of the two groups were compared using the ED95 dose determined in the first part.
Propofol (Part 2):In the second part, with fospropofol disodium as the control, the safety and efficacy of the two groups were compared using the ED95 dose determined in the first part.
Sponsors
Jingzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18–65 years, regardless of gender; 2.American Society of Anesthesiologists (ASA) physical status classification: Grade I–III; 3.Body Mass Index (BMI): 18.5–30 kg/m^2; 4.Patients undergoing elective surgery under general anesthesia with an expected operative time of more than 30 minutes; 5.Voluntarily participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Patients with contraindications to general anesthesia or a history of anesthesia accidents; 2.Patients with central nervous system diseases, coma, a history of brain surgery, or those who cannot undergo anesthesia depth monitoring; 3.Patients with abnormal liver function (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >= 2.5 times the upper limit of normal [ULN]; total bilirubin [TBIL] >= 1.5 times the ULN); 4.Patients with abnormal renal function (serum creatinine [Cr] > the ULN, or those who received dialysis treatment within 28 days before surgery); 5.Patients with a history of drug abuse, alcoholism, or drug dependence; 6.Patients with a history of abuse or long-term use of anesthetics, sedatives, or analgesics; 7.Patients with known or suspected allergy or contraindication to any components of the study drugs, or to sufentanil citrate injection, propofol, remifentanil hydrochloride for injection, or fospropofol disodium for injection as specified in the protocol; 8.Patients with mental system diseases (e.g., depression, anxiety disorder, schizophrenia, mania, cognitive dysfunction, etc.), or those who have taken psychotropic drugs (including sedatives, antidepressants, etc.) for a long time (continuously for 1 month or intermittently for 3 months); 9.Patients who participated in any other clinical drug trials within 1 month before screening; 10.Pregnant or lactating women; women of childbearing potential or men who are unwilling to use contraception throughout the trial period; study participants (including male participants) who plan to become pregnant within 1 month after the trial; 11.Patients who are deemed by the investigators to have any other factors that make them unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 95% Effective Doses (ED95) of Propofol and Fospropofol Disodium;The incidence of hypotension during general anesthesia induction (defined as drug-induced mean arterial pressure [MAP] < 65 mmHg); | — |
Secondary
| Measure | Time frame |
|---|---|
| Induction success rate (defined as a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score = 1 within 5 minutes after the start of intravenous administration of propofol or fospropofol disodium);The time from the first administration of fospropofol disodium to the disappearance of the eyelash reflex;The time interval from the completion of fospropofol disodium administration to the initiation of anesthetic maintenance drugs;Observe and record the heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), SpO?, and Narcotrend (NT) values of patients in both groups at each time point: before anesthesia induction (T0), immediately after anesthesia induction (T1), 5 minutes after anesthesia induction (T2), 10 minutes after anesthesia induction (T3), 15 minutes after anesthesia induction (T4), and at the time of surgical incision (T5); calculate the blood pressure varia;The usage of vasoactive drugs during anesthesia induction ;The incidence of intraoperative awareness;Adverse reaction profile: paresthesia, injection pain, bradycardia (HR < 45 bpm), and prolongation of the Q-T interval.; | — |
Countries
China
Contacts
Public ContactZhang Kun
Jingzhou Central Hospital
Outcome results
None listed