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Clinical Trials/EUCTR2014-005116-41-IT
EUCTR2014-005116-41-IT
Active, Not Recruiting
Phase 1

Postoperative pulmonary function in patients undergoing laparoscopic sleeve gastrectomy after administration of sugammadex and neostigmine. A double-blind, randomized controlled trial. - NEVERS

niversity of Padova0 sites72 target enrollmentApril 13, 2015
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ConditionsReversal of rocuronium-induced neuromuscular blockadeTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsBridion 100 mg/ml solution for injectionPROSTIGMINA

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Reversal of rocuronium-induced neuromuscular blockade
Sponsor
niversity of Padova
Enrollment
72
Status
Active, Not Recruiting
Last Updated
8 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 13, 2015
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity of Padova

Eligibility Criteria

Inclusion Criteria

  • •age over 18 years;
  • •morbid obesity class II (with comorbidities), and class III;
  • •patients undergoing surgery for laparoscopic bariatric surgery
  • •presence of neuromuscular monitoring
  • •presence of moderate neuromuscular blockade (T1\-T2 to 10% TOF
  • •ratio) at the time of reversal
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 72

Exclusion Criteria

  • •obesity class I and II (in the absence of co\-morbidities);
  • •muscle dysfunction (eg. Myasthenia gravis, muscular dystrophy)
  • •cardiac disease (eg. prolong QTc syndrome) and / or cardiac ischemia
  • •renal failure
  • •liver failure
  • •allergic reaction to the drugs used in the study
  • •treatment with oral contraceptives, toremifene, flucloxacillin and
  • •fusidic acid
  • •known or suspected pregnancy;
  • •spontaneous recovery at the end of surgery and / or the presence of

Outcomes

Primary Outcomes

Not specified

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