Reversal of pipecuronium neuromuscular block using sugammadex
- Conditions
- The effect of sugammadex dose on deep neuromuscular blockade willbe investigated, therefore patients suffering from various conditionsundergoing surgery in general anaesthesia with muscle relaxation willbe included in the study.Therapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2015-002019-13-HU
- Lead Sponsor
- niversity of Debrecen, Medical and Health Science Center, Department of Anaesthesiology and Intensive Therapy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Patient aged 18-65 undergoing general surgery under combined
general anaesthesia with neuromuscular
blockade
2. ASA (American Society of Anesthesiology) physical status score 1-3
3. BMI (Body-Mass Index) 18,5-25
4. duration of operation over 100 minutes
5. need for intratracheal intubation
6. supine position, at least one arm accessible
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. diseases influencing neuromuscular function (myopathies, significant
renal or hepatic insufficiency)
2. drugs influencing neuromuscular function (magnesium,
aminoglycosides)
3. gravidity, lactation
4. urgent surgery
5. chronic obstructive pulmonary disease
6. glaucoma
7. difficult airway management possible
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The main objective of the trial is to determine the smallest sugammadex<br>dose, which is suitable for the effective, rapid (within 5 min.) and<br>permanent reversal of<br>deep pipecuronium neuromuscular block.;Secondary Objective: The secondary objective of the trial is to determine the sugammadex<br>dose, which is suitable for slower (within 10 min.) reversal of deep<br>pipecuronium neuromuscular block.;Primary end point(s): Complete and rapid (within 5 minutes) reversal of neuromuscular<br>blockade (return to TOF 100%<br>during neuromuscular monitoring) after the administration of<br>sugammadex.;Timepoint(s) of evaluation of this end point: Neuromuscular function is monitored right after extubation and in the<br>next hour continuously. Further monitoring is performed on the day of<br>the operation to assess any possible complications.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Slow (within 10 minutes) but complete reversal of neuromuscular<br>blockade (return to TOF 100%<br>during neuromuscular monitoring) after the administration of<br>sugammadex or the placebo drug.;Timepoint(s) of evaluation of this end point: Neuromuscular function is monitored right after extubation and in the<br>next hour continuously. Further monitoring is performed on the day of<br>the operation to assess any possible complications.