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The ED50 and ED95 values of fospropofol disodium combined with esilexicam in inhibiting the general anesthesia intubation response in elderly patients

The ED50 and ED95 values of fospropofol disodium combined with esilexicam in inhibiting the general anesthesia intubation response in elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113513
Enrollment
Unknown
Registered
2025-12-01
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intubation response

Interventions

Middle-aged group:Intravenous injection: Sufentanil 0.3µg /kg, esketamine 0.3mg/kg. The disodium phosphopropofol was experimentally analyzed using the Dixon sequential method: Slowly administer disodi

Sponsors

Affiliated Cancer Hospital of Guizhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Age: 45 to 85 years old, gender not limited; 2. Patients who are scheduled for elective surgery under general anesthesia and single-lumen tracheal intubation; 3. The ASA score is Grade I or Grade II; 4.18 kg/m^2< BMI < 28kg/m^2; 5. Clearly understand and voluntarily participate in this research, and sign the informed consent form by oneself.

Exclusion criteria

Exclusion criteria: Patients who have not received regular antihypertensive treatment or have poor blood pressure control (systolic blood pressure >=160 mmHg or =100 mmHg); 2. Heart rate (HR) 100 beats per minute; 3. Uncontrolled diabetes and coronary heart disease; 4. Severe liver and kidney dysfunction (Child-Pugh score > 7, eGFR < 30 ml/min/1.73m^2); 5. Difficult airway; 6. Allergic diseases or allergies to the investigational drugs; 7. Family history of malignant high fever; 8. Patients with untreated or uncontrolled hyperthyroidism; 9. Has participated in other drug clinical trials as a subject within the past three months; 10. Pregnant or breastfeeding, or planning to become pregnant within one month after surgery; 11. History of alcohol abuse or drug abuse;

Design outcomes

Primary

MeasureTime frame
Intubation reaction;

Secondary

MeasureTime frame
Record the MAP and HR of the patients before the start of anesthesia induction (T1) and 1 minute after the disappearance of eyelash reflex (T2). The maximum values of MAP and HR within 3 minutes after intubation (T3);The period from the start of anesthesia to the loss of consciousness of the subject (MOAA/S score <=1) and BIS<=60;Did the patient complain of skin itching and discomfort throughout the injection process;Dosage of vasoactive drugs;

Countries

China

Contacts

Public ContactLi Rui

Affiliated Cancer Hospital of Guizhou Medical University

250353808@qq.com+86 86812999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026