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Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade

NCT01424488 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2011-08-29

No results posted yet for this study

Summary

Primary objectives:

1. to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in subjects undergoing abdominal surgery under general anesthesia
2. to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade

Secondary objectives:

1\. to evaluate the time from the start of sugammadex or placebo administration to the time of extubation and to the time of recovery of TOF ratio to ≥ 0.9

Exploratory objectives:

1. to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay after the end of surgery in subjects with pipecuronium induced neuromuscular blockade reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline)
2. compare the number of patients extubated in the OR after the reversal by sugammadex or placebo, evaluate the TOF ratio at the time of extubation

Clinical hypothesis:

1\. Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced blockade

Conditions

  • Adult Subjects Undergoing Abdominal Surgery Under General Anesthesia

Interventions

DRUG

sugammadex

Anesthetised patients will receive a single intubation dose of succinylcholine (1.0 mg/kg) and maintenance bolus dose of pipecuronium (0.08 mg/kg) to maintain the level of neuromuscular blockade at reappearance of T2 Sugammadex in the dose of 4 mg/kg is to be administered as an intravenous bolus dose at the level of neuromuscular blockade of reappearance of T2 (moderate blockade) by means of TOF-Watch SX after the last dose of pipecuronium according to randomization

DRUG

placebo

Anesthetised patients will receive a single intubation dose of succinylcholine (1.0 mg/kg) and maintenance bolus dose of pipecuronium (0.08 mg/kg) to maintain the level of neuromuscular blockade at reappearance of T2. 3,0 ml of saline (placebo) is to be administered as an intravenous bolus dose at the level of neuromuscular blockade of reappearance of T2 (moderate blockade) by means of TOF-Watch SX after the last dose of pipecuronium according to randomization

Sponsors & Collaborators

  • Central Clinical Hospital #1 of LLC Russian Railways

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Russia

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01424488 on ClinicalTrials.gov