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Phase 4 N=61 Randomized Triple-blind Supportive Care

Effects of Deep Neuromuscular Blockade on Intraoperative Respiratory Mechanics

Laparoscopic Renal Surgery · Laparoscopy · Muscle Relaxation

Enrolled (actual)
61
Serious AEs
0.0%
Results posted
Jun 2016
Primary outcome: Primary: Thoracopulmonary Compliance — 51.9; 52.3; 34.6; 31.9 ml/cmH2O

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Rocuronium (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Seoul St. Mary's Hospital
Primary completion
Jan 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Thoracopulmonary Compliance
51.9; 52.3; 34.6; 31.9; 33.6; 30.8
SECONDARY
Arterial Oxygen Tension/Inspired Oxygen Fraction
477; 483; 467; 461; 468; 465
SECONDARY
Arterial to End-tidal Partial Pressure of Carbon Dioxide Difference
4.3; 4.3; 5.8; 7.1; 5.8; 7.2
SECONDARY
Estimated Dead Space
11.8; 11.9; 14.1; 16.5; 14.1; 16.4
SECONDARY
Pulmonary Shunt
13.2; 12.4; 12.7; 13.2; 15.0; 14.8

Summary

The primary objective of the current study is to compare intraoperative respiratory mechanics in patients receiving laparoscopic renal surgery under deep neuromuscular blockade (dNMB) and under moderate neuromuscular blockade (mNMB). In addition, we will compare intraoperative hemodynamics and postoperative pulmonary function between the two groups.

Eligibility Criteria

Inclusion Criteria

  • ASA I or II patients scheduled to undergo laparoscopic renal surgery

Exclusion Criteria

  • BMI ≥35 kg/m2
  • Known neuromuscular disease
  • History of chronic obstructive pulmonary disease
  • Asthma
  • Pneumothorax
  • Bronchopleural fistula
  • Previous lung surgery
  • Previous retroperitoneal surgery
  • Hemodynamic instability
  • History of cardiopulmonary disease
  • Renal insufficiency
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02185339). 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.

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