Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)

NCT ID: NCT00535496

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2008-02-29

Brief Summary

The objective of the trial is to determine the relationship within a participant between the time to manual detection of the reappearance of the fourth twitch (T4) measured using a peripheral nerve stimulator (PNS) and the time to recovery of the fourth twitch/first twitch (T4/T1) ratio to 0.9 measured using a Train Of Four (TOF)-Watch® SX, of 4.0 mg/kg sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg/kg rocuronium or the last maintenance dose of 0.15 mg/kg rocuronium.

Detailed Description

The TOF-Watch® SX has been used for neuromuscular monitoring in all

clinical trials with sugammadex. In clinical practice however, a PNS is commonly

used in many hospitals worldwide. A disadvantage of a PNS is that it is not objective monitoring like the TOF-Watch® SX, and it can detect only the number of twitches. In this trial, the relationship between the time to reappearance of T4 using PNS (i.e. Ministim® model MS-IV) and the time to recovery of the T4/T1 ratio to 0.9 using the TOF-Watch® SX was determined after a dose of 4.0 mg/kg sugammadex was administered 15 minutes after the last dose of rocuronium. Determining this relationship will enable the provision of advice on when it is safe to extubate participants after administration of 4.0 mg/kg sugammadex for reversing neuromuscular block while using a PNS. The time to reappearance of T4 was assessed by a blinded PNS-assessor. This assessor was blinded for the dose of sugammadex used and for the TOF results measured with the TOF-Watch® SX.

Conditions

Neuromuscular Blockade

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

sugammadex 1.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm)

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.

2

sugammadex 1.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm)

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.

3

sugammadex 4.0 mg/kg, TOF-Watch® SX (dominant forearm) and PNS (non-dominant forearm)

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.

4

sugammadex 4.0 mg/kg, TOF-Watch® SX (non-dominant forearm) and PNS (dominant forearm)

Group Type: EXPERIMENTAL

sugammadex

Intervention Type: DRUG

Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.

Interventions

sugammadex

Participants will receive an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 or 4.0 mg/kg sugammadex will be randomly administered by intravenous (IV) bolus dose based on actual body weight.

Intervention Type: DRUG

Other Intervention Names

Org 25969; Bridion®; MK-8616; SCH 900616

Eligibility Criteria

Inclusion Criteria

• American Society of Anesthesiologists (ASA) Class 1 or 2 or 3
• between the ages of 18 to 64 years, inclusive
• scheduled for a surgical procedure under general anesthesia requiring

neuromuscular relaxation with the use of rocuronium

• scheduled for a surgical procedure in supine position
• have given written informed consent

Exclusion Criteria

• participants with a difficult intubation because of expected anatomical

malformations

• known or suspected to have neuromuscular disorders impairing

neuromuscular blockade and/or significant hepatic and/or renal

dysfunction

• medical or physical condition that is expected to interfere

with the proper conduct of simultaneous neuromuscular monitoring on

both arms

• known or suspected to have a (family) history of malignant

hyperthermia

• known or suspected to have arthritis or another disease that will

cause the thumb not to move freely

• known or suspected to have an allergy to narcotics, muscle

relaxants or other medication used during general anesthesia

• is receiving medication in a dose and/or at a time point known to

interfere with neuromuscular blocking agents (NMBAs), such as antibiotics, anticonvulsants and Mg2+

• already participated in a sugammadex trial
• participated in another clinical trial, not pre-approved, within prior 30 days
• pregnant females
• breast-feeding females

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Drobnik L, Sparr HJ, Thorn SE, Khuenl-Brady KS, Rietbergen H, Prins ME, Ullman J. A randomized simultaneous comparison of acceleromyography with a peripheral nerve stimulator for assessing reversal of rocuronium-induced neuromuscular blockade with sugammadex. Eur J Anaesthesiol. 2010 Oct;27(10):866-73. doi: 10.1097/EJA.0b013e32833b1b85.

Reference Type: RESULT

PMID: 20523215 (View on PubMed)

Other Identifiers

19.4.313

Identifier Type: -

Identifier Source: secondary_id

P05698

Identifier Type: -

Identifier Source: org_study_id