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Efficacy of Sugammadex in Magnesium Pretreated Patients

NCT01440933 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-07-10

No results posted yet for this study

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

Interventions

DRUG

Magnesium Sulfate

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.

DRUG

Placebo comparator

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.

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Christoph A Czarnetzki, MD, MBA · Universital Hospitals of Geneva

  • Martin R Tramer, MD, Dphil · University Hospitals of Geneva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Switzerland

Study Locations

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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 NCT01440933 on ClinicalTrials.gov