MedTrace Logo

The ED95 Dose of Sugammadex to Reverse Rocuronium-Induced Deep Neuromuscular Block Back to Shallow Neuromuscular Block

NCT05841316 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2023-08-09

No results posted yet for this study

Summary

In the European Society of Anaesthesiology and Intensive Care (ESAIC) guideline on the use of neuromuscular blockers published in 2023, it was suggested that sugammadex could be used to reverse deep and moderate neuromuscular blockade, and that neostigmine could be used to reverse superficial neuromuscular block (expressed as Train-of-Four Ratio (TOFR) 0.4 and above) to TOFR 0.9. Therefore, it has been hypothesized that a transition from deep neuromuscular block to superficial neuromuscular block can be achieved with lower than standard dose of sugammadex, followed by usual dose of neostigmine which results complete neuromuscular recovery from superficial neuromuscular block.

This study is planned with 2 stages. In the first phase of the study, the main goal is to determine the dose of sugammadex that would reverse the rocuronium induced deep neuromuscular block (PTC 1 to 3) to superficial neuromuscular block (TOFR: 0.4) in 95% of patients in 5 minutes following administration.

Conditions

  • Deep Neuromuscular Blockade
  • Anesthesia, General

Interventions

DRUG

Sugammadex

During the surgery, the desired level of neuromuscular block will be deep and followed by post-tetanic-count (PTC) of 1 to 3 in every 5 minutes. 0.3-1mg/kg/h rocuronium will be infused to ensure PTC of 1 to 3. At the end of the surgery, 0,6 mg sugammadex will be given as a bolus in the first patient of the study. The duration between the completion of sugammadex injection and the first measurement of Train-of-four ratio (TOFR) of 0.4 will be recorded. If the TOFR is achieved to 0.4 after sugammadex bolus of 0,6 mg/kg in 5 minutes, the result of reversal will be evaluated as positive. The consecutive patient will be given the same or decreased dose of sugammadex by 0,2 mg/kg according to the randomisation scheme. If the patient fails to recover from deep neuromuscular block to superficial block in 5 minutes after a given dose of sugammadex, the consecutive patient will be administered increased dose of sugammadex by 0,2 mg/kg.

Sponsors & Collaborators

  • Ankara University

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2023-12-31
Completion
2023-12-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05841316 on ClinicalTrials.gov