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A comparative study on the use of sugammadex sodium versus neostigmine for rapid extubation in elderly patients after transurethral resection of bladder tumor

A comparative study on the use of sugammadex sodium versus neostigmine for rapid extubation in elderly patients after transurethral resection of bladder tumor

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093177
Enrollment
Unknown
Registered
2024-11-29
Start date
2024-12-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

bladder cancer

Interventions

Neostigmine group:Intravenous injection of neostigmine at 0.05 mg/kg, combined with atropine at 0.015 mg/kg
Sugammadex group:Intravenous injection of sugammadex sodium at 2 mg/kg

Sponsors

The First Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patients scheduled for TURBT (Transurethral Resection of Bladder Tumor) need to undergo general anesthesia; 2.Elderly patients aged 65-85 years; 3.ASA classification I to III; 4.No preoperative pulmonary abnormalities such as pulmonary infection, pleural effusion, atelectasis, or respiratory failure; 5.The patient and their family understand this study, voluntarily agree to participate in the trial, and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1.Patients allergic to medications such as sugammadex sodium, neostigmine, or similar drugs; 2.Perioperative use of medications known to interact with rocuronium bromide; 3.Acute cardiovascular events, including acute or decompensated heart failure and acute coronary syndrome; 4.Patients with severe hepatic, renal, or pulmonary dysfunction; 5.Patients with neuromuscular diseases or assessed neuromuscular dysfunction; 6.Emergency surgery; 7.Participants are either involved in another clinical study or refuse to participate in this clinical study; 8.Patients with psychiatric disorders, cognitive impairment, or communication difficulties; 9.Patients deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
The time from the administration of sugammadex sodium or neostigmine to the removal of the endotracheal tube;

Secondary

MeasureTime frame
Patient's age, weight, height, gender, and any comorbid underlying diseases;The additional dose of rocuronium bromide administered during surgery, duration of the surgery, fluid balance (input and output), and the occurrence of intraoperative adverse events;The time for neuromuscular reversal to achieve a TOFr of >=0.90 after administering the muscle relaxant, the TOFr value at the time of endotracheal tube removal, and the length of stay in the PACU;The incidence of peripheral blood oxygen saturation below 90% in the first 10 minutes after extubation;The incidence of pneumonia, atelectasis, pleural effusion within 7 days postoperatively; the incidence of mechanical ventilation lasting longer than 48 hours and unplanned reintubation;BIS, heart rate, blood pressure, temperature, and ECG;The time of first flatus and first bowel movement postoperatively;The occurrence of nausea, vomiting, rash, myocardial ischemia, and other related events;

Countries

China

Contacts

Public ContactYaomin Zhu

The First Affiliated Hospital of Xi'an Jiaotong University

zhuyaomin_mzk@163.com+86 18629382846

Outcome results

None listed

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