Comparative Study of Rocuronium With Vecuronium (Study 71101)(COMPLETED)

NCT ID: NCT00970762

Last Updated: 2015-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-02-29

Brief Summary

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This study was conducted to determine and compare the safety and effectiveness of two neuromuscular blockers (rocuronium and vecuronium) at various doses in adults who are undergoing general elective surgery with sevoflurane anesthesia.

Study participants received an intubating dose of a neuromuscular blocker (to enable insertion of a tube through the nose or mouth into the trachea to provide artificial ventilation). The intubating dose was followed by repeated bolus maintenance doses as needed, to maintain muscle relaxation. The time it takes to reach maximal effect of the neuromuscular blocker (onset time) after the intubating dose was measured and compared as the primary outcome.

Detailed Description

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The TOF Watch-SX (acceleration transducer) was used in the measurement of neuromuscular blocking action.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rocuronium 0.6 INT, 0.1 MNT

Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.

Group Type EXPERIMENTAL

Rocuronium 0.6 mg/kg intubating dose

Intervention Type DRUG

Rocuronium 0.6 mg/kg intubating dose

Rocuronium 0.1 mg/kg maintenance dose

Intervention Type DRUG

Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.

Rocuronium 0.6 INT, 0.15 MNT

Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.

Group Type EXPERIMENTAL

Rocuronium 0.6 mg/kg intubating dose

Intervention Type DRUG

Rocuronium 0.6 mg/kg intubating dose

Rocuronium 0.15 mg/kg maintenance dose

Intervention Type DRUG

Rocuronium 0.15 mg/kg maintenance dose following the intubating dose

Rocuronium 0.6 INT, 0.2 MNT

Participants in this group received a 0.6 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.

Group Type EXPERIMENTAL

Rocuronium 0.6 mg/kg intubating dose

Intervention Type DRUG

Rocuronium 0.6 mg/kg intubating dose

Rocuronium 0.2 mg/kg maintenance

Intervention Type DRUG

Rocuronium 0.2 mg/kg maintenance dose following the intubating dose

Rocuronium 0.9 INT, 0.1 MNT

Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.1 mg/kg maintenance dose of rocuronium.

Group Type EXPERIMENTAL

Rocuronium 0.9 mg/kg intubating dose

Intervention Type DRUG

0.9 mg/kg intubating dose of rocuronium

Rocuronium 0.1 mg/kg maintenance dose

Intervention Type DRUG

Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.

Rocuronium 0.9 INT, 0.15 MNT

Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.15 mg/kg maintenance dose of rocuronium.

Group Type EXPERIMENTAL

Rocuronium 0.9 mg/kg intubating dose

Intervention Type DRUG

0.9 mg/kg intubating dose of rocuronium

Rocuronium 0.15 mg/kg maintenance dose

Intervention Type DRUG

Rocuronium 0.15 mg/kg maintenance dose following the intubating dose

Rocuronium 0.9 INT, 0.2 MNT

Participants in this group received a 0.9 mg/kg intubating dose of rocuronium followed by 0.2 mg/kg maintenance dose of rocuronium.

Group Type EXPERIMENTAL

Rocuronium 0.9 mg/kg intubating dose

Intervention Type DRUG

0.9 mg/kg intubating dose of rocuronium

Rocuronium 0.2 mg/kg maintenance

Intervention Type DRUG

Rocuronium 0.2 mg/kg maintenance dose following the intubating dose

Vecuronium 0.1 INT, 0.025 MNT

Participants in this group received a 0.1 mg/kg intubating dose of vecuronium followed by 0.025 mg/kg maintenance dose of vecuronium.

Group Type ACTIVE_COMPARATOR

Vecuronium 0.1 mg/kg intubating dose

Intervention Type DRUG

Vecuronium 0.1 mg/kg intubating dose

Vecuronium 0.025 mg/kg maintenance dose

Intervention Type DRUG

Vecuronium 0.025 mg/kg maintenance dose following the intubating dose

Interventions

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Rocuronium 0.6 mg/kg intubating dose

Rocuronium 0.6 mg/kg intubating dose

Intervention Type DRUG

Rocuronium 0.9 mg/kg intubating dose

0.9 mg/kg intubating dose of rocuronium

Intervention Type DRUG

Rocuronium 0.1 mg/kg maintenance dose

Rocuronium 0.1 mg/kg maintenance dose following the intubating dose.

Intervention Type DRUG

Rocuronium 0.15 mg/kg maintenance dose

Rocuronium 0.15 mg/kg maintenance dose following the intubating dose

Intervention Type DRUG

Rocuronium 0.2 mg/kg maintenance

Rocuronium 0.2 mg/kg maintenance dose following the intubating dose

Intervention Type DRUG

Vecuronium 0.1 mg/kg intubating dose

Vecuronium 0.1 mg/kg intubating dose

Intervention Type DRUG

Vecuronium 0.025 mg/kg maintenance dose

Vecuronium 0.025 mg/kg maintenance dose following the intubating dose

Intervention Type DRUG

Other Intervention Names

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Zemuron Org 9426 Zemuron Org 9426 Zemuron Org 9426 Zemuron Org 9426 Zemuron Org 9426 Norcuron Norcuron

Eligibility Criteria

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Inclusion Criteria

* at least 20 but under 65 years of age
* American Society of Anesthesiologists (ASA) Class 1, 2 or 3 for general elective surgery
* not considered to be pregnant
* scheduled for elective surgery under sevoflurane or propofol anesthesia with an anticipated duration of about 1.5-3 hours
* normal laboratory values

Exclusion Criteria

* certain medical conditions or medical histories
* receiving certain medications or treatments
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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71101

Identifier Type: -

Identifier Source: secondary_id

P05975

Identifier Type: -

Identifier Source: org_study_id

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