A randomised, control, assessor blinded, dose escalating study to compare

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2005
INTERVENTION: Trade Name: Rocuronium Bromide (Esmeron) Product Name: Esmeron Product Code: 05003/0041 Pharmaceutical Form: Solution for injection INN or Proposed INN: Rocuronium Bromide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10‐ Trade Name: Suxamethonium Product Name: Suxamethonium Chloride Pharmaceutical Form: Solution for injection INN or Proposed INN: Suxamethonium Chloride Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50‐ CONDITION: Patients undergoing Anaesthesia PRIMARY OUTCOME: Main Objective: To find the dose of rocuronium that provides conditions equal to those encountered when using suxamethonium whilst performing a rapid sequence induction Primary end point(s): The primary outcome to be measured is the ‘intubation Conditions score’. We wish to demonstrate which dose of rocuronium provides intubating conditions equal to those with suxamethonium in 9/10 subjects Secondary Objective: Are there any safety issues associated with the dose of rocuronium which provides equal intubating conditions to those of suxamethonium INCLUSION CRITERIA: ASA class I‐III aged 18‐65 scheduled to undergo elective surgery 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 3944fc423b5ca060931e6ab7762fb09098046183
First added on: Aug 21, 2024