Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy

Phase 4

Completed

• Conditions: Neuromuscular Block; Esophageal Cancer; Surgery
• Interventions: Drug: Rocuronium

• Registration Number: NCT02320734
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-12-12
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-19
• Study Start: 2015-02
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Last Update Submitted: 2016-09-16
• Last Update Posted: 2016-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
deep neuromuscular relaxation	Rocuronium	continuous infusion of rocuronium 0.6 mg/kg/hr (group 1). On demand bolus rocuronium can be given if demanded by anesthesiologist or surgeon

Primary Outcome Measures

Name	Time	Method
Rating of surgical conditions (SRS) during the abdominal phase of the operation.	during operation

Secondary Outcome Measures

Name	Time	Method
Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.	during operation and an average of 4 weeks thereafter	amount of rocuronium used (mg); Dose of sugammadex needed (mg), duration of surgery, hypothetical need for post-operative ventilation if sugammadex would not be available(%).
Rating of SRS during thoracic phase of the operation.	during operation
Number of on demand boluses infused, indication of on demand bolus administration	during operation
Number of correct estimates of group randomization by surgeons	directly after operation	Surgeons will guess in which group the patient was randomized (%) and the reason for this choice will be registrated. Accordingly we can estimate whether the surgeons complaints of inadequate NMB are justified and additionally, the chance of bias affecting main outcome parameter.
Rating of anesthesia conditions	during operation	peak and mean respiratory pressure, incidence peak insufflation pressure \>35 mmHg. Depth of NBM at the end of surgery. Time until spontaneous breathing, time until extubation. Peroperative cardiac and respiratory incidents, peroperative surgical complications.Tiem to reversal of NMB, % of recurarisation

Trial Locations

Locations (1)

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands