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

NCT00535496 | Completed Phase 3 Results

• 2 other identifiers: P0569819.4.313
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neuromuscular Blockade

Outcome Measures

Primary Outcomes (3)

• Time From Start of Administration of 4.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX

  Neuromuscular function was monitored by applying repetitive TOF electrical stimulations with the TOF-Watch® SX to the ulnar nerve of one forearm every 15 seconds \& assessing twitch response at the adductor pollicis muscle with the TOF-Watch® SX. T1 and T4 are the magnitudes (heights) of the first and fourth twitches respectively after TOF nerve stimulation, where stimulation was continued until the T4/T1 ratio reached 0.9. A higher T4/T1 ratio indicates a lower degree of neuromuscular blockade, with a value of 1.0 representing full recovery. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.

  Up to 4 minutes after administering sugammadex

• Time From Start of Administration of 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a Peripheral Nerve Stimulator (PNS)

  Neuromuscular function was monitored with a PNS by applying repetitive TOF stimulation to the ulnar nerve of one forearm every 15 seconds and assessing the number of twitches at the adductor pollicis muscle by a blinded PNS assessor. T4 is the fourth twitch after TOF nerve stimulation. Only participants treated with 4.0 mg/kg sugammadex are presented, where the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.

  up to 2 minutes after administering sugammadex

• Difference in Time Between Recovery of T4/T1 Ratio to 0.9 as Measured by TOF Watch® SX, and Reappearance of T4 as Measured by PNS, Within Participants, After Administration of 4.0 mg/kg Sugammadex

  The difference between the recovery of T4/T1 ratio to 0.9 and reappearance of T4 within participants was assessed from an ANOVA method. Only participants treated with 4.0 mg/kg sugammadex are presented, where the TOF-Watch® SX on the dominant forearm n =30, and on the non-dominant forearm n = 31; and the PNS on the dominant forearm n =31, and on the non-dominant forearm n = 30. The 1.0 mg/kg sugammadex group was not evaluated for this outcome measure.

  Up to 3 minutes after administering sugammadex

Other Outcomes (5)

• Time From Start of Administration of 1.0 mg/kg Sugammadex to Recovery of the T4/T1 Ratio to 0.9 Measured by a TOF-Watch® SX

  Up to 150 minutes after administering sugammadex

• Time From Start of Administration of 1.0 or 4.0 mg/kg Sugammadex to Reappearance of T4 Measured by a TOF-Watch® SX

  Up to 7 minutes after administering sugammadex

• Time From Start of Administration of 1.0 mg/kg Sugammadex to Reappearance of T4 Measured by a PNS

  Up to 5 minutes after administering sugammadex

Study Arms (4)

1

EXPERIMENTAL

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

Drug: sugammadex

2

EXPERIMENTAL

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

Drug: sugammadex

3

EXPERIMENTAL

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

Drug: sugammadex

4

EXPERIMENTAL

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

Drug: sugammadex

Interventions

sugammadex 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.

Also known as: Org 25969, Bridion®, MK-8616, SCH 900616

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• 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.

  PMID: 20523215 RESULT

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2007
• First Posted: September 26, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 17, 2015
• Results First Posted: September 2, 2013

Record last verified: 2015-02