Clinical trial NCT00559468: Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)
Official title: A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex , Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anesthesia, General
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.


Eligibility criteria: Inclusion Criteria:

* Participants at least 20 years but under 65 years of age;
* Participants of American Society of Anesthesiologists (ASA) class 1-3;
* Participants scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of a neuromuscular blocking agent (NMBA) with an anticipated duration of surgery between 2 and 5 hours;
* Participants scheduled for a surgical procedure in supine position;
* Participants who had given written informed consent.

Exclusion Criteria:

* Participants in whom difficult intubation was expected because of anatomical malformations;
* Participants known or suspected to have neuromuscular disorders affecting NMB and/or significant renal dysfunction. In Germany, this also included serum creatinine and blood urea nitrogen outside local reference ranges;
* Participants known or suspected to have a (family) history of malignant hyperthermia;
* Participants known or suspected to have an allergy to medications used during general anesthesia;
* Participants receiving medication interfering with NMBAs, such as antibiotics, anticonvulsants and Mg\^2+; based on the dose and time of administration;
* Pregnant or lactating females;
* Female participants of childbearing potential not using any birth control or using only hormonal contraception as birth control;
* Participants who had already participated in trial CT 19.4.312, or in another trial with sugammadex;
* Participants who had participated in another clinical trial, not pre-approved by Organon, within 30 days of entering into CT 19.4.312.

Primary outcomes:
measure: Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9
timeFrame: Up to 3 minutes after sugammadex administration
Secondary outcomes:
measure: Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7
timeFrame: Up to 3 minutes after sugammadex administration
measure: Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8
timeFrame: Up to 3 minutes after sugammadex administration
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Rex C, Wagner S, Spies C, Scholz J, Rietbergen H, Heeringa M, Wulf H. Reversal of neuromuscular blockade by sugammadex after continuous infusion of rocuronium in patients randomized to sevoflurane or propofol maintenance anesthesia. Anesthesiology. 2009 Jul;111(1):30-5. doi: 10.1097/ALN.0b013e3181a51cb0.