Efficacy of Sugammadex in Magnesium Pretreated Patients

NCT01440933 | Completed Phase 2

• 1 other identifier: CER 10-093
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

Sugammadex is a new reversal agent for neuromuscular blockers (curare). It encapsulates the curare molecule and terminates immediately its action. The recommended dose is 2 mg/kg for a slight neuromuscular block and 4 mg/kg for a profound neuromuscular block. Magnesium sulphate is frequently used in perioperative medicine and it is known to reinforce the neuromuscular block induced for instance by rocuronium. The researchers want to investigate, whether higher doses of sugammadex must be given to antagonize the neuromuscular block induced by rocuronium in patients who received magnesium sulphate.

Conditions

Neuromuscular Block

Keywords

sugammadex; rocuronium; magnesiumsulphate; neuromuscular monitoring

Outcome Measures

Primary Outcomes (1)

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.9

  Neuromuscular function will be assessed by acceleromyography of the adductor pollicis with a TOF-Watch SX® monitor (Organon Oss, The Netherlands). After induction of anesthesia and loss of consciousness, the acceleromyograph will be calibrated using the implemented TOF-Watch SX® calibration mode 2. Train-of-four (TOF) stimulation will be used (supramaximal square wave impulse of 200 µs duration, four stimuli at two Hz, 15 seconds interval). The units of measurement are seconds and minutes. Measurement will be continued until a TOF ration of 1.0 is reached.

  Participants will be followed for the duration of hospital stay, an expected average of 2 days

Secondary Outcomes (2)

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.7

  Participants will be followed for the duration of hospital stay, an expected average of 2 days

• Time from start administration of sugammadex to recovery T4/T1 ratio to 0.8.

  SParticipants will be followed for the duration of hospital stay, an expected average of 2 days

Study Arms (2)

Magnesiumsulphate

ACTIVE COMPARATOR

Drug: Magnesium Sulfate

Physiologic saline

PLACEBO COMPARATOR

Drug: Placebo comparator

Interventions

Magnesium Sulfate DRUG

1ml/kg of the study solution containing 60 mg/ml of magnesium sulphate are given intravenously over 15 minutes in the conscious patient. After anaesthesia induction and calibration of neuromuscular monitoring (TOF Watch SX - acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) (PTC 2) or reappearance of 2 twitches of the Train of four (superficial neuromuscular block) 4 mg/kg (deep neuromuscular block) or 2 mg/kg (superficial neuromuscular block) of Sugammadex are given intravenously.

Magnesiumsulphate

Placebo comparator DRUG

1ml/kg of the study solution containing physiologic saline are given intravenously over 15 minutes in the conscious patient. After anaesthesia induction and calibration of neuromuscular monitoring (TOF Watch SX - acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) (PTC 2) or reappearance of 2 twitches of the Train of four (superficial neuromuscular block) 4 mg/kg (deep neuromuscular block) or 2 mg/kg (superficial neuromuscular block) of Sugammadex are given intravenously.

Physiologic saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age ≥18 to 60 years, male.
• American Society of Anesthesiology \[ASA\] status I or II.
• Able to read and understand the information sheet and to sign and date the consent form.
• Scheduled for elective surgery lasting at least 60 minutes under general anaesthesia requiring neuromuscular relaxation using rocuronium bromide for endotracheal intubation.

You may not qualify if:

• A history of allergy or hypersensitivity to rocuronium, sugammadex or magnesium
• Neuromuscular disease.
• Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics \[aminoglycosides\] and anticonvulsants \[phenytoine\]).
• Electrolyte abnormalities (for instance, hypermagnaesemia).
• Hepatic dysfunction (i.e bilirubin \<1.5 upper limit normal (ULN), alanine aminotransferase (ALT) \<2.5 x ULN, aspartate aminotransferase (AST) \<2.5 x ULN)
• Renal insufficiency (i.e. Creatinine \<1.5 x ULN, creatinine clearance \<30ml/minute).
• Atrioventricular heart block
• Patients with magnesium treatment
• Patients with a body mass index \<19 or \>28 kg m-2.
• Pregnant, or intending to become pregnant, women.
• Breastfeeding women.
• Expected difficult intubation or mask ventilation.
• Patient having participated in any clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial.
• Patients needing continuous or repeat rocuronium administration for surgical reasons.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

University Hospitals of Geneva

Geneva, 1211, Switzerland

Location

MeSH Terms

Interventions

Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Christoph A Czarnetzki, MD, MBA

  Universital Hospitals of Geneva

  PRINCIPAL INVESTIGATOR

• Martin R Tramer, MD, Dphil

  University Hospitals of Geneva

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsable Investigator

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 27, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

CH (1)