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Efficacy and safety of domestic sugammadex in Chinese adult patients: a randomized, double-blinded, active-control, noninferiority clinical trial

Efficacy and safety of domestic sugammadex in Chinese adult patients: a randomized, double-blinded, active-control, noninferiority clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071764
Enrollment
Unknown
Registered
2023-05-24
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Adult patients scheduled surgery under general anesthesia

Interventions

study group:deep blockade reversed with domestic sugammadex
control group:deep blockade reversed with Bridion

Sponsors

Department of Anesthesiology, Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, ASA I-III; 2. Patients undergoing elective surgery under general anesthesia and using rocuronium during operation.

Exclusion criteria

Exclusion criteria: 1. Patients with cirrhosis or liver failure and moderate renal dysfunction (glomerular filtration rate 40) or weight > 100 kg; 4. Suspected allergic patients to rocuronium and sugammadex; 5. Pregnant and lactating patients.

Design outcomes

Primary

MeasureTime frame
time from the start of administration of sugammadex to recovery of the TOF ratio to 0.9;

Secondary

MeasureTime frame
TOFr values at 1min, 2min, 3min and 5min after Drug Administration;The ratio of TOFr to 0.9 within 3min;Blood pressure and heart rate within 5min of Drug Administration;Recover indoor adverse events;Incidence of respiratory complications 24 hours after surgery;

Countries

China

Contacts

Public ContactZhiyu Geng

Department of Anesthesiology, Peking University First Hospital, Beijing, China

gengzhiyu2013@163.com+86 136 8112 1461

Outcome results

None listed

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