Clinical trial NCT00474253: Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)
Official title: A Multicenter, Randomized, Parallel Group, Comparative, Active-Controlled, Safety-Assessor Blinded, Phase IIIa, Trial, in Adult Subjects Comparing Recovery From 1.2 mg.Kg-1 Rocuronium Followed by 16 mg.Kg-1 Org 25969 at 3 Minutes With Recovery From 1.0 mg.Kg-1 Succinylcholine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-05-16
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Class 1 or 2 physical status;
* 18 to 65 years of age (inclusive);
* Scheduled for elective surgical procedure under general anesthesia requiring a short duration of neuromuscular block with the use of rocuronium or succinylcholine and requiring endotracheal intubation;
* Scheduled for surgery in supine position;
* Body mass index (BMI) \< 30;
* Given written informed consent.

Exclusion Criteria:

* Has ischemic heart disease or history of myocardial infarction within the last year;
* May experience difficult intubation due to anatomical malformations;
* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant renal dysfunction;
* Known or suspected family history of malignant hyperthermia;
* Known or suspected allergy to narcotics, muscle relaxants, midazolam, anesthetics or other medications used during surgery;
* Is receiving medication known to interfere with neuromuscular blocking agents such as anticonvulsants, antibiotics and Mg2+;
* Individuals in whom the use of neostigmine and/or glycopyrrolate may be contraindicated;
* Females who are pregnant or breast-feeding;
* Females of childbearing potential who are not using an acceptable method of birth control \[condom or diaphragm with spermicide, vasectomized partner (\> 6 months), IUD, abstinence\];
* Has already participated in a sugammadex trial including Protocol 19.4.303.

Primary outcomes:
measure: Time to Recovery of T1 to 10% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration
timeFrame: Up to 15 minutes after administration of rocuronium + sugammadex or succinylcholine
Secondary outcomes:
measure: Time to Recovery of T1 to 90% of Baseline Value From Start of Rocuronium + Sugammadex or Succinylcholine Administration
timeFrame: Up to 20 minutes after administration of rocuronium + sugammadex or succinylcholine
measure: Level of Consciousness: Number of Participants Awake and Oriented
timeFrame: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine
measure: Level of Consciousness: Number of Participants Arousable With Minimal Stimulation
timeFrame: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine
measure: Level of Consciousness: Number of Participants Responsive Only to Tactile Stimulation
timeFrame: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine
measure: Number of Participants Able to Perform 5-Second Head Lift
timeFrame: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine
measure: Number of Participants Experiencing General Muscle Weakness
timeFrame: Up to 24 hours after administration of rocuronium + sugammadex or succinylcholine
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Lee C, Jahr JS, Candiotti KA, Warriner B, Zornow MH, Naguib M. Reversal of profound neuromuscular block by sugammadex administered three minutes after rocuronium: a comparison with spontaneous recovery from succinylcholine. Anesthesiology. 2009 May;110(5):1020-5. doi: 10.1097/ALN.0b013e31819dabb0.