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Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuromuscular Blockade

Intervention: rocuronium (Drug); sugammadex (Drug); succinylcholine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.

Clinical Details

Official title: A Multi-center, Randomized, Parallel Group, Comparative, Active Controlled, Safety Assessor Blinded Trial in Adult Subjects Comparing Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Subjects Undergoing Short Surgical Procedures in Out-patient Surgicenters

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Rocuronium or Succinylcholine

Change From Baseline in Plasma Potassium Levels at 5 Minutes After Treatment With Sugammadex

Secondary outcome:

Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Rocuronium or Succinylcholine

Change From Baseline in Plasma Potassium Levels at 2 Minutes After Treatment With Sugammadex

Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Rocuronium or Succinylcholine

Change From Baseline in Plasma Potassium Levels at 10 Minutes After Treatment With Sugammadex

Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Rocuronium or Succinylcholine

Change From Baseline in Plasma Potassium Levels at 15 Minutes After Treatment With Sugammadex

Number of Participants With at Least One Adverse Event (AE) in Rocuronium - Sugammadex and Succinylcholine Treatment Groups

Time to Recovery of the Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9 Following Administration of 4.0 mg/kg of Sugammadex After Neuromuscular Blockade Induced by Rocuronium

Time to Recovery of T1 to 90% of Baseline Following Neuromuscular Blockade Induced by Succinylcholine

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female subjects >=18 years of age;

- ASA Class 1-3;

- Subjects with a Body Mass Index (BMI) of < 35 kg/m^2 ;

- Subjects scheduled to undergo an elective short procedure with general anesthesia

requiring neuromuscular relaxation and endotracheal intubation in outpatient surgicenters;

- Subjects scheduled to undergo an elective surgical procedure expected to last 1. 5

hours or less (from end of intubation to end of suturing/stapling of skin);

- Subjects who are scheduled to undergo an elective surgical procedures that allows

access to the arm for TOF-Watch® SX monitoring;

- Subjects who have given written informed consent.

Exclusion Criteria:

- Subjects known to have ischemic heart disease or a history of myocardial infarction;

- Subjects in whom a difficult intubation is expected because of anatomical

malformations;

- Subjects with medical conditions and/or undergoing surgical procedures that are not

compatible with the use of the TOF-Watch SX (e. g., injuries to the thumbs/distal forearms, bilateral ulnar nerve damage or subjects with cardiac pacemakers);

- Subjects known or suspected to have neuromuscular disorders impairing neuromuscular

blockade (e. g., subjects with myasthenia gravis);

- Subjects who would require the use of pneumatic tourniquet during the surgical

procedure;

- Subjects known or suspected to have significant renal dysfunction (e. g., creatinine

clearance < 30 mL per min);

- Subjects known or suspected to have significant hepatic dysfunction;

- Subjects known or suspected to have a (family) history of malignant hyperthermia;

- Subjects known or suspected to be hypersensitive to sugammadex or other cyclodextrins

or rocuronium or any of its excipients;

- Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants,

or other medications used during general anesthesia;

- Subjects for whom a pre-established need for post operative intensive care admission

and/or hospital admission is expected;

- Subjects for whom an intra operative IV administration of fluids that contain

potassium is expected;

- Female subjects who are pregnant;

- Female subjects who are breast-feeding;

- Subjects who have participated in a previous sugammadex trial;

- Subjects who have participated in another investigational drug trial within 30 days

before entering into clinical trial (CT) 19. 4.319 (P05700) unless pre-approved by the sponsor.

Locations and Contacts

Additional Information

Starting date: November 2008
Last updated: June 3, 2015

Page last updated: August 23, 2015

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