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Phase 4 N=24 Randomized Double-blind Prevention

Effect of Deep BLock on Intraoperative Surgical Conditions

Prostate Hypertrophy · Renal Disease

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Surgical Rating Scale — 4; 4.7 units on a scale (1-5) — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Surgical block (rocuronium; atracurium/mivacurium) (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Leiden University Medical Center
Primary completion
Mar 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Surgical Rating Scale
4; 4.7 <0.001 sig
SECONDARY
Breathing
14.5; 14.5
SECONDARY
Post-operative Pain
2.6; 2.1
SECONDARY
Postoperative Sedation Score
2.0; 1.3
SECONDARY
Nausea and Vomiting
0; 0

Summary

Rationale: A deep neuromuscular block is often associated with improved surgical conditions especially in laparoscopic surgery. However, a deep block comes at the expense of a variety of items that may conflict with the use of a deep surgical muscle blockade including a long recovery phase, the need for muscle reversal, postoperative ventilation, impaired postoperative breathing. With the introduction of Sugammadex there is now the possibility to reverse an even deep surgical block. This may overcome most if not all of the issues mentioned. Objective: To assess whether a deep neuromuscular block provides better surgical conditions than a moderately deep block as derived from a surgical rating score. Study design: Single center, double-blind randomized controlled trial. Study population: 24 ASA I-III patients scheduled for laparoscopic renal (n=12, GROUP 1) or prostatic surgery (n=12, GROUP 2). Intervention: In both GROUP 1 and GROUP 2, 6 six patients will receive neuromuscular blockade according to current practice (atracurium (bolus) plus mivacurium (cont. infusion)) aimed at a moderately deep neuromuscular block (1-2 twitches in the Train of Four (TOF) monitor). The other six will receive a bolus plus continuous infusion with rocuronium aimed at a deep neuromuscular block (1-2 twitches post tetanic count (PTC)). All surgical procedures will be performed by one surgeon. Main study parameters/endpoints: To study the surgical conditions in patients undergoing laparoscopic renal or prostate surgery during deep versus less deep neuromuscular block as assessed by the surgical rating score. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Compared to current practice there will be no additional risk.

Eligibility Criteria

Inclusion Criteria

  • Patients diagnosed with renal or prostatic disease who are will undergo an elective laparoscopic renal surgical procedure or laparoscopic prostatectomy;
  • ASA class I-III
  • > 18 years of age;
  • Ability to give oral and written informed consent

Exclusion Criteria

  • Known or suspected neuromuscular disorders impairing neuromuscular function;
  • Allergies to muscle relaxants, anesthetics or narcotics;
  • A (family) history of malignant hyperthermia;
  • Patients who have a contraindication for neostigmine administration;
  • Women who are or may be pregnant or are currently breast feeding;
  • Renal insufficiency, as defined by serum creatinine x 2 of normal, or urine output 35 kg/m2
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01631149). 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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