Phase 4 N=37 Randomized Triple-blind Treatment

Optimizing Surgical Conditions During Laparoscopic Herniotomy With Deep Neuromuscular Blockade

Laparoscopic Herniotomy

Bottom Line

View on ClinicalTrials.gov: NCT02247466 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Improvement of Surgical Workspace — 0; 1; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Rocuronium and Sugammadex (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Herlev Hospital
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Improvement of Surgical Workspace	0; 1; 0; 0; 0; 4	—
SECONDARY Surgical Conditions While Suturing	0; 0; 0; 0; 0; 2	—
SECONDARY Operating Time	61; 64	—
SECONDARY Suturing Time	10; 9	—
SECONDARY Contractions	1; 0	—
SECONDARY Insufflator Alarms	0; 0	—
SECONDARY Continuous Abdominal Contractions	0; 0	—
SECONDARY Recurrences of Hernias	—	—

Summary

The purpose of this study is to investigate surgical work space and surgical conditions in patients scheduled for laparoscopic umbilical, -linea alba and incisional herniotomy. The patients will act as their own control with evaluation of surgical work space and surgical conditions during both deep NMB and no NMB.

Eligibility Criteria

Inclusion Criteria

Patients > 18 years old
Elective laparoscopic umbilical herniotomy, incisional herniotomy and linea alba - herniotomy
Can read and understand Danish
Informed consent

Exclusion Criteria

Known allergy to sugammadex, rocuronium or mivacurium
Known homozygous variants in the butyrylcholinesterase gene
Severe renal disease, defined by S-creatinine> 0.200 mmol/L, GFR < 30ml/min or hemodialysis)
Neuromuscular disease that may interfere with neuromuscular data
Lactating or pregnant (Women of child bearing potential must take a urine pregnancy test at the day of the operation. The test will be provided by the hospital staff).
Indication for rapid sequence induction

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Data sourced from ClinicalTrials.gov (NCT02247466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.