Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Anesthesia, General

Treatments: Drug: Sevoflurane; Drug: Sugammadex; Drug: Rocuronium; Drug: Propofol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00559468

MK-8616-028 (Other Identifier)

P05949

2006-004072-12 (Other Identifier)

19.4.312 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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52 participants in 2 patient groups

Sugammadex + Sevoflurane

Experimental group

Description:

After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.

Treatment:

Drug: Rocuronium

Drug: Sugammadex

Drug: Sevoflurane

Sugammadex + Propofol

Experimental group

Description:

After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.

Treatment:

Drug: Propofol

Drug: Rocuronium

Drug: Sugammadex