Induction-period hypotension
Conditions
Interventions
Ciprofol group:Continuous infusion at 7.5 mg/kg/h until PSI = 50
Propofol group:Continuous infusion at 30 mg/kg/h until PSI = 50
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients classified as ASA III/IV, aged >=18 years scheduled to undergo elective gastrointestinal tumor radical resection under general anesthesia with an expected duration >=90 minutes. 2. Requiring endotracheal intubation for mechanical ventilation and invasive arterial blood pressure monitoring. 3. No history of cognitive impairment OR capable of providing informed consent. 4. All patients to undergo preoperative fasting and receive the identical bowel preparation protocol. 5. Continued routine morning medications on the day of surgery (with the exclusion of angiotensin-converting enzyme inhibitors [ACEIs] and angiotensin II receptor blockers [ARBs]). 6. Female patients of childbearing potential must fulfill all of the following: (1) Two negative pregnancy tests (first during initial screening, second before trial drug administration); (2) Agreement to use highly effective contraception from the last menstruation until trial follow-up completion. Highly effective contraception includes: 1) Combined estrogen- and progestogen-containing hormonal contraception (oral/vaginal/transdermal); 2) Progestogen-only hormonal contraception (oral/injectable/implantable); 3) Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS); 4) Bilateral tubal ligation; 5) Partner sterilization (if partner is the sole sexual partner and procedure is confirmed successful); 6) Abstinence. 7. Considered non-childbearing if meeting any of the following criteria: (1) Last menstruation >=2 years ago; (2) Prior sterilizing surgery (e.g., bilateral oophorectomy, hysterectomy, etc.).
Exclusion criteria
Exclusion criteria: 1. Surgery-related exclusions: (1) Scheduled to receive central neuraxial anesthesia (spinal anesthesia, epidural anesthesia) or regional anesthesia (except for placement of epidural catheter for postoperative analgesia or local anesthesia after wound closure); (2) Emergency surgery; 2. Health status exclusions: (1) Left ventricular ejection fraction (LVEF) 30 kg/m^2; (5) Alzheimer's disease and epilepsy; (6) Laboratory abnormalities: total bilirubin >= 3.0 mg/dL, or AST/ALT >= 3 times the upper limit of normal (testing must be completed within 7 days prior to dosing); (7) End-stage renal disease requiring regular dialysis; (8) Allergy or contraindication to benzodiazepines, cyclopropofol, propofol, opioid analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), neuromuscular blocking agents, flumazenil, naloxone, or other anesthetic agents; (9) Allergy to milk sugar, soybean oil, or excipients of cyclopropofol; (10) Acute pain concomitant before surgery, such as multiple fractures, traumatic injury, etc.; 3. Other exclusions: (1) Acute alcohol or drug intoxication, shock, or coma; (2) Baseline mean arterial pressure (MAP) < 65 mmHg prior to anesthesia induction; (3) Upper extremity peripheral arterial disease affecting radial artery pressure monitoring (e.g., subclavian artery stenosis); (4) Known dependence on central nervous system depressant drugs or alcohol; (5) Anticipated or known difficult airway (e.g., limited mouth opening, restricted neck mobility, thyroid enlargement, head/neck tumor, Mallampati grade 3 or 4) or difficult mask ventilation; (6) Unreliable PSI monitoring due to organic defects of the brain or forehead, or neurological disorders; (7) Treatment with sodium valproate; (8) Pregnant or lactating patients; (9) Participation in other clinical trials within the past 30 days or 5 times the half-life of the investigational drug (whichever is longer), excluding non-interventional studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time-weighted cumulative area of mean arterial pressure reduction within 10 minutes after induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time at which the Patient State Index (PSI) dropped to 50;Time to Loss of Consciousness (LOC);Rate of post-induction hypotension;Total Dose of Vasopressor (Norepinephrine) Administered;Area under the curve of mean arterial pressure below 65 mmHg within 10 minutes after induction; | — |
Countries
China
Contacts
Public ContactYang Xuming
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed