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Comparison of the effects of fospropofol disodium and propofol on the occurrence of hypotension during anesthesia induction in patients undergoing general anesthesia surgery: a randomized controlled trial

Comparison of the effects of fospropofol disodium and propofol on the occurrence of hypotension during anesthesia induction in patients undergoing general anesthesia surgery: a randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078140
Enrollment
Unknown
Registered
2023-11-29
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Patients undergoing general anesthesia

Interventions

Intervention group:10mg/kg Fospropofol Disodium
Control group:2mg/kg propofol

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) 65 years old = 18 years old, BMI=18-30kg/m2, ASA I-III level; (2) Perform elective surgery under simple general anesthesia; (3) Able to understand the research content and operations, and sign an informed consent form to be included in the study.

Exclusion criteria

Exclusion criteria: (1) Individuals who have experienced anesthesia accidents in the past; (2) Complicated neurological diseases: such as craniocerebral injury and stroke; (3) Patients with uncontrolled hypertension, severe hypotension, or heart disease prior to surgery; (4) Individuals with allergies or contraindications to experimental drugs or other anesthetic drugs; (5) Individuals who have participated in any drug clinical trial within one month prior to screening; (6) The researchers believe that subjects with any other unfavorable factors for participating in this experiment.

Design outcomes

Primary

MeasureTime frame
The area of mean arterial pressure (MAP) during the observation period at the hypotension threshold (65mmHg);

Secondary

MeasureTime frame
Hypotension incidence rate, hypotension incidence rate, hypertension incidence rate, maximum hypertension value, MAP area above the hypertension threshold (100mmHg) at observation period ;Bradycardia incidence, lowest heart rate, highest heart rate at observation period ;Systolic blood pressure, mean arterial pressure, maximum fluctuation value of heart rate (difference between maximum or minimum value and basic value) at observation period ; The lowest and highest BIS values areas with BIS less than 40, and areas with BIS greater than 60 during the observation period ;Time to start using inhaled anesthetics after intubation; Dosage of vasoactive drugs and proportion of patients using vasoactive drugs during observation period;Perioperative adverse reactions (injection pain, abnormal sensation, postoperative nausea and vomiting, etc.);The incidence of intraoperative awareness among patients (modified Brice assessment questionnaire, evaluation time point: before PACU and the first day after surgery);Satisfaction evaluation of anesthesiologists;Blood sample testing: ? Blood adrenaline concentration; ? Blood norepinephrine concentration; ? Blood cortisol concentration, etc;

Countries

China

Contacts

Public ContactChan Chen

West China Hospital, Sichuan University

xychenchan@gmail.com+86 189 8060 6260

Outcome results

None listed

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