Reversal of pipecuronium neuromuscular block using sugammadex

• Conditions: The effect of sugammadex dose on residual 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: EUCTR2012-000259-14-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

Study Timeline

• Study Start: 2012-06-25
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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. 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

Exclusion Criteria

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
;
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