Adverse Effects, Remifentanil
Conditions
Brief summary
Explore the effect of remifentanil on pruritus and paresthesia induced by fospropofol disodium in adults
Detailed description
Explore the effect of remifentanil on pruritus and paresthesia caused by fospropofol disodium in adults, to observe the manifestations and duration of pruritus and paresthesia
Interventions
DRUGRemifentanil
Observe the incidence of pruritus and paresthesia after different doses of remifentanil and fospropofol disodium
DRUGSufentanil
Observe the incidence of pruritus and paresthesia after sufentanil and fospropofol disodium
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-80 years old, plans to undergo elective non-cardiac surgery under general anesthesia. * ASA I-II; * The operation duration \> 30 min; * BMI 18-30kg /m2； * Sign the informed consent form.
Exclusion criteria
* history of drug abuse or alcohol dependence; * used sedative or analgesic drugs before operation; * with severe liver and kidney function impairment; * allergic to propofol and lipids; * surgery that directly affect hemodynamics with surgical operations, such as macrovascular surgery; * abnormal coagulation function, endocrine diseases or other effects on hemodynamic status; * Participation in other clinical researchers in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pruritus and paresthesia after administration of fospropofol disodium | 24 hours | Observe the incidence of pruritus and paresthesia in patients within 3 minutes after administration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of pruritus or paresthesia | 1 day | time of pruritus and paresthesia occur after administration and 24h after surgery |
| dosage of drugs | 1 day | Doses of drugs used during induction and maintenance of anesthesia |
| time records checklist | 1 day | anesthesia time, induction time, surgical time, awakening time, and recovery time |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 1 day | Incidence of Treatment-Emergent Adverse Events |
| duration of pruritus or paresthesia | 24 hours | pruritus and paresthesia occur after administration and 24h after surgery |
Countries
China
Outcome results
None listed