clinical study of identifying the appropriate PTC range for sugammadex 3 mg/kg and evaluating its non-inferiority versus 4 mg/kg in deep neuromuscular blockade

A two-part prospective clinical study of identifying the appropriate PTC range for sugammadex 3 mg/kg and evaluating its non-inferiority versus 4 mg/kg in deep neuromuscular blockade

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0012219

Enrollment

176

Registered

2026-07-02

Start date

2026-07-06

Completion date

Unknown

Last updated

2026-07-13

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

Conditions

None listed

Interventions

Drug : Part 1 (Pilot Exploratory Study) Part 1 will enroll approximately 30 adult patients scheduled for elective surgery under general anesthesia. During surgery, at a time point between peritoneal c

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult patients aged 19 years or older who are scheduled to undergo elective surgery under general anesthesia Patients for whom deep neuromuscular blockade will be maintained intraoperatively using rocuronium Patients classified as ASA Physical Status I–II Patients with a body mass index (BMI) of less than 30 kg/m² Patients who have received a full explanation of the study and have provided written informed consent to participate

Exclusion criteria

Exclusion criteria: Patients with neuromuscular disorders or muscle diseases (e.g., Myasthenia Gravis) Patients with severe hepatic impairment or renal impairment Patients with a history of hypersensitivity to Sugammadex or Rocuronium Patients who are pregnant or breastfeeding Patients receiving medications that may affect recovery from neuromuscular blockade due to drug interactions or other mechanisms Patients deemed unsuitable for study participation at the investigator’s discretion

Design outcomes

Primary

Measure	Time frame
Whether a TOF Ratio of 90% or higher is reached within 3 minutes after Sugammadex administration at a specific PTC value	—

Secondary

Measure	Time frame
PTC range showing effective neuromuscular blockade reversal with Sugammadex 3 mg/kg administration;Time taken to reach TOF ratios of 70%, 80%, 90%, and 100% after Sugammadex administration;Whether recurarization occurs and whether additional Sugammadex administration is necessary, dosage;Postoperative respiratory complications (e.g., hypoxia, airway obstruction, etc.)	—

Countries

Korea, Republic of

Contacts

Public ContactEunjin Song

Chonnam National University Hwasun Hospital

ejsong94@naver.com+82-62-220-6895

Outcome results