Depth of Neuromuscular Blockade and the Perioperative Conditions in Laparoscopic Surgery in Pediatric Population

NCT02546843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2019-05-20

No results posted yet for this study

Summary

This randomized study prospectively evaluates our experience with administration of cisatracurium and rocuronium antagonized by sugammadex and evaluates the effects of various depths of neuromuscular blockage on providing optimal surgical conditions during laparoscopy with low-pressure capnoperitoneum.

Conditions

  • Neuromuscular Blockade

Interventions

DRUG

Rocuronium

rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)

DRUG

Cisatracurium

cisatracurium 0.15mg/kg intravenously

DRUG

Nonspecific Neuromuscular Blockade reversal

neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously

DRUG

Specific Neuromuscular Blockade reversal

Sugammadex intravenously aimed to reverse the neuromuscular blockade.According to neuromuscular blockade monitoring: at TOF - (train-of-four) 2m g/kg, if TOF 0 and PTC(post-tetanic count) 0-1 4mg/kg of sugammadex will be administered

DRUG

maintaining the depth of neuromuscular blockade - rocuronium

repeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1

DRUG

maintaining the depth of neuromuscular blockade - cisatracurium

repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1

Sponsors & Collaborators

  • KDCHOT FN Brno

    collaborator UNKNOWN
  • Brno University Hospital

    lead OTHER

Principal Investigators

  • Petr Štourač, MD, Ph.D · KDAR FN Brno

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2018-09-30
Completion
2019-05-31

Countries

  • Czechia

Study Locations

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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 NCT02546843 on ClinicalTrials.gov