Reversal With Sugammadex From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial

Neuromuscular Blockade Clinical Trial

— SUGAPED-01  

Official title:

Reversal With Sugammadex (BRIDION ®) From Deep Neuromuscular Blockade Induced by Rocuronium in Children: Randomised Clinical Trial of Efficacy and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01809886
• Other study ID #: CT-PED-2010-01CT
• Secondary ID: 2011-000401-50
• Status: Completed
• Phase: Phase 3
• First received: August 28, 2012
• Last updated: March 5, 2014
• Start date: October 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2014
• Source: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to prove that the administration of sugammadex at a dose of 4 mg/kg for counteracting deep blockage [without train-of-four (TOF) ratio response and post-tetanic count (PTC) < of 2 induced and maintained with Rocuronium in pediatric patients for short-term elective surgery.

Description:

Muscle relaxing facilitates endotracheal intubation and surgical access. Muscle relaxants have a long duration with the possibility of residual muscle relaxation after surgery (over 40% of patients), and ventilatory problems (hypoxia, hypercapnia, atelectasis, airway collapse) that raise postoperative morbidity and mortality.

All of these facts are accentuated in the pediatric patient due to the reduced airway caliber which tends lead to obstruction and bronchospasm. So far, the effect of muscle relaxants has only been partially reversed by anticholinesterase (neostigmine), which has the limitation of its short duration of action (8-9 minutes) and has many side effects (bradycardia, hypotension, increased salivation, vomiting, dyspnea and bronchoconstriction). It also needs to be combined with anticholinergic (atropine), which causes a dry mouth, blurred vision and tachycardia.

At present, the introduction of sugammadex (Bridion®), an antagonist of nondepolarizing the neuromuscular relaxant rocuronium, may lead to an extraordinary breakthrough. It is the only antagonist able to encapsulate and fully eliminate the muscle relaxant to avoid residual effects and respiratory complications. Muscle strength can be retrieved at any time, without waiting for relaxant metabolism (30 to 40 minutes) and without using the usual classical antidotes (neostigmine and atropine), which produce many undesirable effects that become more troublesome in the postoperatory phase. Sugammadex lacks intrinsic activity and is considered safe, without significant side effects and can be used in cardiovascular or respiratory diseases.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

Inclusion Criteria:

• Children of both sexes,

• Aged between two and eleven years who have undergone surgery for procedures of short duration (less than one hour) and requiring muscle relaxation.

• Informed consent signed by parents or guardians

Exclusion Criteria:

• No signed informed consent by parent/guardian,

• Anticipated difficult airway,

• Neuromuscular disease,

• Liver and/or renal failure,

• Personal or family history of malignant hyperthermia,

• Previous allergic reaction to any anesthetic.

• Treated at the time of the study with aminoglycosides, magnesium, or anticonvulsants.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuromuscular Blockade

Intervention

Drug:
• Sugammadex
50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC<2).
• Neostigmine
50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC<2).

Locations

Country	Name	City	State
Spain	Mª Dolores Cárceles Barón	El Palmar	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia	Hospital Universitario Santa Maria del Rosell, Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The time in seconds which has elapsed until a T4/T1 ratio >0,9.		After surgery (Up to 10 h)	Yes
Secondary	Heart Rate (beats / min)		After surgery (Up to 10 h)	Yes
Secondary	Systolic and Diastolic blood pressure (mm HG)		After surgery (up to 10 h)	Yes
Secondary	Arterial oxygen saturation (%)		After surgery (up to 10 h)	Yes
Secondary	Total dose of rocuronium (mg/kg)		After surgery (up to 10 h)	No
Secondary	Number of participants with at least One Adverse event (AE)		up to 24 h	Yes
Secondary	Time in seconds from the initial dose administered of rocuronium until the maximum block is achieved(Onset time)		During peri-anesthetic period (up to 10 h)	No
Secondary	The time in seconds which has elapsed until a T4/T1 >0,8 is achieved.		After surgery (up to 10 h)	No
Secondary	The time in seconds which has elapsed until a T4/T1 ratio >0,7		After surgery (up to 10 h)	No