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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Central Clinical Hospital #1 of LLC Russian Railways.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Eduard Nikolaenko, Central Clinical Hospital #1 of LLC Russian Railways
ClinicalTrials.gov Identifier:
NCT01424488
First received: August 22, 2011
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Adult Subjects Undergoing Abdominal Surgery Under General Anesthesia
Drug: sugammadex
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized, Parallel-group, Placebo-controlled, Safety-assessor Blinded Trial in Adult Subjects Evaluating the Efficacy and Safety of Sugammadex for Reversal of Pipecuronium-induced Neuromuscular Blockade in Subjects Undergoing Abdominal Surgery Under General Anesthesia

Further study details as provided by Central Clinical Hospital #1 of LLC Russian Railways:

Primary Outcome Measures:
  • time from the start of sugammadex or placebo administration (reappearance of T2) to recovery of the TOF ratio to 0.9 [ Time Frame: during peri-anesthetic period (after the surgery and until 10 hours after the surgery) ] [ Designated as safety issue: Yes ]
    measurement of time from the start of sugammadex or placebo administration (reappearance of T2) to recovery of the TOF ratio to 0.9


Secondary Outcome Measures:
  • time from the start of sugammadex or placebo administration to the time of extubation [ Time Frame: during peri-anesthetic period (after the surgery and until 10 hours after the surgery ] [ Designated as safety issue: Yes ]
    measurement of time from the start of sugammadex or placebo administration to the time of extubation


Estimated Enrollment: 42
Study Start Date: September 2011
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sugammadex group
4 mg/kg of sugammadex for reversal of pipecuronium-induced neuromuscular blockade
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
Other Name: Bridion
Placebo Comparator: placebo group
3 ml of saline (placebo) for reversal of pipecuronium-induced neuromuscular blockade
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

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of ASA class 1-3
  • Subjects of age ≥ 18 years
  • Subjects undergoing abdominal surgery under general anesthesia who receives succinylcholine for tracheal intubation and pipecuronium for maintenance of neuromuscular blockade
  • Subjects who have given written informed consent

Exclusion Criteria:

  • Subjects in whom a difficult intubation is expected
  • Subjects known or suspected to have neuromuscular disorders affecting NMB
  • Subjects known or suspected to have a significant renal dysfunction or a severe hepatic dysfunction
  • Subjects known or suspected to have (family) history of malignant hyperthermia
  • Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia
  • Female subjects who are pregnant
  • Female subjects who are breast-feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424488

Contacts
Contact: Eduard Nikolaenko, MD PhD +7 495 490 1216 ednicolayenko@yahoo.com, Evgenia.Bukharova@merck.com
Contact: Evgenia Bukharova, MD PhD +7 985 4104618 Evgenia.Bukharova@merck.com

Locations
Russian Federation
Central Clinical Hospital #1 of LLC "Russian Railroad" Not yet recruiting
Moscow, Russian Federation, 125367
Contact: Eduard Nikolaenko, MD PhD    +7 495 490 1216    ednicolayenko@yahoo.com, Evgenia.Bukharova@merck.com   
Sponsors and Collaborators
Central Clinical Hospital #1 of LLC Russian Railways
  More Information

No publications provided

Responsible Party: Eduard Nikolaenko, Professor Nikolaenko, Central Clinical Hospital #1 of LLC Russian Railways
ClinicalTrials.gov Identifier: NCT01424488     History of Changes
Other Study ID Numbers: CCHRussianRailways
Study First Received: August 22, 2011
Last Updated: August 26, 2011
Health Authority: Russia: Independent Ethic Committee of CCHRussianRailways

Keywords provided by Central Clinical Hospital #1 of LLC Russian Railways:
sugammadex
reversal
pipecuronium-induced neuromuscular blockade

Additional relevant MeSH terms:
Pipecuronium
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 31, 2014