Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)

NCT00298831 | Completed Phase 3 Results

• 3 other identifiers: P0594319.4.311MK-8616-023
• Study Type: interventional
• Target: 224
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

• Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.9

  Mean time from start of MK-8616 administration to recovery of participant T4/T1 ratio to 0.9 was assessed through the repeated application (every 15 seconds) of an electrical stimulation protocol. Specifically, 4 electrical stimulations were applied to the ulnar nerve and the magnitude of the twitch response of the adductor pollicis muscle (i.e. thumb twitch response) was assessed. With T4 and T1 referring to the respective magnitude of the fourth and first thumb twitch during nerve stimulation, the T4/T1 ratio indicates the current degree of neuromuscular blockade (NMB) present in the participant as a decimal from 0 (loss of T4 twitch) to 1 (no NMB). Further, reduced recovery time of the T4/T1 ratio to 0.9 indicates faster recovery from NMB. Summary data, originally presented in the format of units "minutes:seconds" (mm:ss), was reformatted to be presented in the single unit of "minutes" (min).

  Up to approximately 30 minutes following administration of study treatment

Secondary Outcomes (5)

• Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.7

  Up to approximately 10 minutes following administration of study treatment

• Time From Start of MK-8616 Administration to Recovery of the T4/T1 Ratio to 0.8

  Up to approximately 15 minutes following administration of study treatment

• Clinical Assessment of Recovery - Participant's Level of Consciousness

  Up to 24 hours

• Clinical Assessments of Recovery - Participant Able to Perform 5-second Head Lift (5SHL)

  Up to 24 hours

• Clinical Assessments of Recovery - Check for General Muscle Weakness (GMW)

  Up to 24 hours

Study Arms (1)

Sugammadex

EXPERIMENTAL

Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg MK-8616 was administered.

Drug: Sugammadex; Drug: Rocuronium

Interventions

Sugammadex DRUG

At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.

Also known as: Org 25969, MK-8616

Sugammadex

Rocuronium DRUG

Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.

Sugammadex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) Class 1-3 participants who are scheduled to undergo an elective surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium.

You may not qualify if:

• Participants with neuromuscular disorders, significant renal dysfunction, malignant hyperthermia, allergy to medications used in general anesthesia and in whom difficult intubation is expected.
• Participants taking medications known to interfere with neuromuscular blocking agents.
• Participants who are of child-bearing potential, pregnant, and breast feeding

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Hudson ME, Rietbergen H, Chelly JE. Sugammadex is effective in reversing rocuronium in the presence of antibiotics. BMC Anesthesiol. 2014 Aug 15;14:69. doi: 10.1186/1471-2253-14-69. eCollection 2014.

  PMID: 25157214 DERIVED

Related Links

• Click here to access a synopsis of the study results.

MeSH Terms

Interventions

Sugammadex; Rocuronium

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates; Androstanols; Androstanes; Steroids; Fused-Ring Compounds

Results Point of Contact

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

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: March 1, 2006
• First Posted: March 3, 2006
• Study Start: October 27, 2005
• Primary Completion: May 22, 2006
• Study Completion: May 22, 2006
• Last Updated: March 27, 2019
• Results First Posted: March 15, 2019

Record last verified: 2019-03