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Effect of fospropofol disodium and propofol on the quality of recovery after total intravenous anesthesia

Effect of fospropofol disodium and propofol on the quality of recovery after total intravenous anesthesia

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094928
Enrollment
Unknown
Registered
2024-12-30
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

total intravenous anesthesia

Interventions

fospropofol disodium:fospropofol disodium 20mg/kg + sufentanil 0.1ug/kg, pump infusion of fospropofol disodium 10-20 mg/kg/h
propofol:Propofol 2mg / kg + sufentanyl 0.1 ug / kg, pump injection of propofol 4-12 mg / kg / h

Sponsors

The Affiliated Suzhou Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age: 18 to 65 years, female, (BMI): 18.5 to 30 kg/m^2; ASA I and II; Subjects undergoing elective hysteroscopy surgery; Non-acute hospitalized subject with appropriate preoperative preparation; Vital signs: respiratory rate 10 ~24 beats / min; air oxygen saturation (SpO 2) >=95%; systolic blood pressure (SBP)>=90mmHg and =60mmHg and=55 and<=100 beats / min; Understanding the process and methods of the study, voluntarily participated in it and signed the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with contraindications to general anaesthesia or a history of anesthesia accidents; (2) Have known or suspected allergy or contraindications to propofol injection and opioids; (3) Combined with brain loss, intracranial hypertension, stroke, unstable angina pectoris, myocardial infarction; (4) Respiratory insufficiency, obstructive pulmonary disease, presence of difficult airway or being judged as difficult tracheal intubation (modified horse score grade III or IV) (5) uncontrolled diabetes mellitus or hypertension; (6) severe liver dysfunction or severe renal insufficiency; (7) History of alcohol abuse or drug dependence; (8) Abuse or long-term application of anesthesia, sedation and analgesic drugs; (9) A previous history of mental illness; (10) Those who have participated in any drug clinical trial within 1 month before the screening; (11) Subjects for whom the investigator considers any other factor inappropriate to participate in this trial.

Design outcomes

Primary

MeasureTime frame
QoR15 score at 24 hours postoperatively;

Secondary

MeasureTime frame
QoR15 score;vital signs;Time-related indicators;Dosage of drugs used;satisfaction;

Countries

China

Contacts

Public ContactGu chengyong

The Affiliated Suzhou Hospital of Nanjing Medical University

gcygcy1979@163.com+86 512 6236 3036

Outcome results

None listed

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