Fospropofol Disodium Induced Paresthesia/Pruritus
Conditions
Interventions
Esketamine Group (Group K):Esketamine Combined with Fospropofol Disodium
Control Group (Group N):Fospropofol Disodium
Sponsors
Fuyang Hospital Affiliated to Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Female patients scheduled for laparoscopic surgery requiring endotracheal intubation, with an expected postoperative NRS score < 3 and an anticipated surgical duration < 3 hours; 2. Aged 18–59 years; 3. BMI 18–30 kg/m^2; 4. ASA physical status I–II; 5. Voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergy to any of the investigational drugs involved; 2. Patients with contraindications to esketamine (e.g., glaucoma and major vascular aneurysm); 3. Poorly controlled hypertension or diabetes mellitus; 4. Severe cardiac, hepatic, or renal disease; 5. Serum alkaline phosphatase levels exceeding 1.5 times the upper limit of normal; 6. Significant prolongation of QTcF interval =480 ms and/or prior exposure to certain QT-prolonging drugs within 2 weeks before screening; 7. History of alcohol/drug abuse or psychiatric disorders; 8. Patients requiring admission to the ICU postoperatively; 9. Pregnant or lactating patients; 10. Known or anticipated difficult airway; 11. Patient refusal.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of paresthesia/pruritus; | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Recovery-15 (QoR-15) Score;SBP/DBP, MAP, HR, and BIS values at the following time points: before induction of anesthesia (T1), after successful induction (T2), immediately after endotracheal intubation (T3), 5 minutes after intubation (T4), at the time of pneumoperitoneum establishment (T5), 30 minutes after pneumoperitoneum (T6), and at the end of surgery (T7).;BIS values at the following time points: before induction of anesthesia (T1), after successful induction (T2), immediately after endotracheal intubation (T3), 5 minutes after intubation (T4), at the establishment of pneumoperitoneum (T5), 30 minutes after pneumoperitoneum (T6), and at the end of surgery (T7).;Time to successful induction (defined as MOAA/S score <= 1);Incidence of adverse reactions during the induction period;Pain Numerical Rating Scale (NRS) Score;Self-Rating Anxiety Scale (SAS) Score;Hallucinations, nightmares, and other psychiatric symptoms; | — |
Countries
China
Contacts
Public ContactFushi Wang
Fuyang Hospital Affiliated to Anhui Medical University
Outcome results
None listed