Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy

Condition(s) targeted: Neuromuscular Block; Esophageal Cancer; Surgery

Intervention: Rocuronium (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Official(s) and/or principal investigator(s):
Markus W Hollmann, prof, Study Chair, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Denise P Veelo, MD, PhD, Principal Investigator, Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Overall contact:
Denise P Veelo, MD, PHD, Phone: +31205669111, Email: d.p.veelo@amc.uva.nl

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.

Official title: A Randomized Controlled Double-blinded Trial Comparing the Effect of on Demand vs Deep Neuromuscular Relaxation on Rating of Surgical and Anesthesia Conditions in Patients Undergoing Thoraco-laparoscopic Esophagectomy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Primary outcome: Rating of surgical conditions (SRS) during the abdominal phase of the operation.

Secondary outcome:

Rating of SRS during thoracic phase of the operation.

Number of on demand boluses infused, indication of on demand bolus administration

Rating of anesthesia conditions

Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.

Number of correct estimates of group randomization by surgeons

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor

Lewis or McKeown variant)

- Written informed consent

Exclusion Criteria:

- pregnancy

- Known allergies for aminosteroid-type muscle relaxants or sugammadex.

- Severe kidney dysfunction (GFR < 30), patients on dialysis

- Liver function disorders

- Myasthenia Gravis or other (neuro)muscular diseases

- Patients with carcinomatosis

- Use of anti-epileptics and lithium or drugs containing Kinin

Denise P Veelo, MD, PHD, Phone: +31205669111, Email: d.p.veelo@amc.uva.nl

Academic Medical Center, Amsterdam, Noord-Holland 1105 AZ, Netherlands; Recruiting
Denise P Veelo, MD, PhD, Email: d.p.veelo@amc.nl
Markus W Hollmann, prof, Email: m.w.hollmann@amc.nl

Starting date: February 2015
Last updated: February 14, 2015