NCT00559468

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2006

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
11.2 years until next milestone

Results Posted

Study results publicly available

February 8, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

3 months

First QC Date

November 14, 2007

Results QC Date

September 13, 2018

Last Update Submit

November 13, 2019

Conditions

Anesthesia, General

Outcome Measures

Primary Outcomes (1)

  • Mean Time From Start Administration of Sugammadex to Recovery of Fourth Twitch/First Twitch (T4/T1) Ratio to 0.9

    Neuromuscular functioning was monitored by applying repetitive Train of Four (TOF) electrical stimulations to the ulnar nerve every 15 seconds and assessing twitch response at the adductor pollicis muscle. T1 and T4 refer to the amplitudes (heights) of the first and fourth twitches, respectively, after TOF nerve stimulation. The T4/T1 ratio (expressed as a decimal from 0 \[loss of T4\] up to 1.0 \[no NMB\]) indicates the extent of recovery from NMB. In this study, twitch responses were recorded until the T4/T1 Ratio reached \>= 0.9, the minimum acceptable ratio that indicated recovery from NMB. A faster time to recovery of the T4/T1 ratio to 0.9 indicates a faster recovery from NMB.

    Up to 3 minutes after sugammadex administration

Secondary Outcomes (2)

  • Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.7

    Up to 3 minutes after sugammadex administration

  • Mean Time From Start of Administration of Sugammadex to Recovery of the T4/T1 Ratio to 0.8

    Up to 3 minutes after sugammadex administration

Study Arms (2)

Sugammadex + Sevoflurane

EXPERIMENTAL

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.

Drug: SugammadexDrug: RocuroniumDrug: Sevoflurane

Sugammadex + Propofol

EXPERIMENTAL

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.

Drug: SugammadexDrug: RocuroniumDrug: Propofol

Interventions

SugammadexDRUG

Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium

Also known as: Org 25969, MK-8616
Sugammadex + PropofolSugammadex + Sevoflurane
RocuroniumDRUG

Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium

Also known as: Esmeron®, Rocuronium Bromide
Sugammadex + PropofolSugammadex + Sevoflurane
SevofluraneDRUG

Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.

Also known as: Ultane®
Sugammadex + Sevoflurane
PropofolDRUG

Propofol IV administered for induction and maintenance of anesthesia, based on randomization.

Also known as: Diprivan®
Sugammadex + Propofol

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 19512873RESULT

Related Links

MeSH Terms

Interventions

SugammadexRocuroniumSevofluranePropofol

Intervention Hierarchy (Ancestors)

gamma-CyclodextrinsCyclodextrinsMacrocyclic CompoundsPolycyclic CompoundsDextrinsStarchGlucansPolysaccharidesCarbohydratesAndrostanolsAndrostanesSteroidsFused-Ring CompoundsMethyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

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
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2007

First Posted

November 16, 2007

Study Start

December 7, 2006

Primary Completion

March 2, 2007

Study Completion

March 2, 2007

Last Updated

November 25, 2019

Results First Posted

February 8, 2019

Record last verified: 2019-11