Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy
Status:
Completed
Trial end date:
2016-09-01
Target enrollment:
Participant gender:
Summary
Rationale: Endoscopic (thoraco-laparoscopic) esophageal surgery is a high risk procedure
where the use of deep neuromuscular block (NMB) may increase field visibility and anaesthesia
conditions. Under these conditions, boluses of muscle relaxants can be given on indication
only OR by continuous infusion. We hypothesize that deep NMB by continuous infusion of
rocuronium as compared to on demand bolus administration facilitates surgical and anesthesia
conditions during thoraco-laparoscopic esophageal resection but higher doses of sugammadex
are needed to reverse NMB at the end of surgery.
Objective: Primary objective is to evaluate the use of deep muscle relaxation versus on
indication only on surgical and anesthesia conditions in patients for endoscopic esophageal
resection. Secondary objectives are to evaluate the (hypothetical) dose of sugammadex needed
in both groups in an economical perspective and to compare the intra-operative cardiac and
respiratory incidents and post-operative complication rate of both groups.
Study design: a single-center randomized controlled double-blinded intervention study.
Study population: All patients > 18 years to undergo a thoracolaparoscopic esophageal
resection.I Intervention: Patients are randomized to receive either continuous infusion of
rocuronium 0.6 mg/kg/hr (group 1) or continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group
2). On demand boluses of Rocuronium 0.3 mg/kg can be given in both groups.
Main study parameters/endpoints: The primary outcome parameter of this study is the SRS
during the abdominal phase of thoracolaparoscopic esophageal surgery. Secondary outcomes
measured are SRS during the thoracic phase, the number of on demand boluses infused, the dose
of Sugammadex needed in both groups to reach a TOF of > 90%, duration of surgery, a
cost-analysis, the incidence of intra-operative cardiac and respiratory incidents and the
ability of surgeons to estimate which neuromuscular blocking regime was given to the patient.
Phase:
Phase 4
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)