Effect of Deep BLock on Intraoperative Surgical Conditions
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
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.