Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade
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
1 other identifier
interventional
42
1 country
1
Brief 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
- 3.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)
- 4.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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2011
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 22, 2011
CompletedFirst Posted
Study publicly available on registry
August 29, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedAugust 29, 2011
August 1, 2011
5 months
August 22, 2011
August 26, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time from the start of sugammadex or placebo administration (reappearance of T2) to recovery of the TOF ratio to 0.9
measurement of time from the start of sugammadex or placebo administration (reappearance of T2) to recovery of the TOF ratio to 0.9
during peri-anesthetic period (after the surgery and until 10 hours after the surgery)
Secondary Outcomes (1)
time from the start of sugammadex or placebo administration to the time of extubation
during peri-anesthetic period (after the surgery and until 10 hours after the surgery
Study Arms (2)
sugammadex group
EXPERIMENTAL4 mg/kg of sugammadex for reversal of pipecuronium-induced neuromuscular blockade
placebo group
PLACEBO COMPARATOR3 ml of saline (placebo) for reversal of pipecuronium-induced neuromuscular blockade
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Clinical Hospital #1 of LLC "Russian Railroad"
Moscow, Moscow, 125367, Russia
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Nikolaenko
Study Record Dates
First Submitted
August 22, 2011
First Posted
August 29, 2011
Study Start
September 1, 2011
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
August 29, 2011
Record last verified: 2011-08