Clinical trial NCT02320734: Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Block
Esophageal Cancer
Surgery
Keywords: surgical rating scale
neuromuscular relaxation
Anaesthesia
minimally invasive esophagectomy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2014-12-19
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Rating of surgical conditions (SRS) during the abdominal phase of the operation.
timeFrame: during operation
Secondary outcomes:
measure: Rating of SRS during thoracic phase of the operation.
timeFrame: during operation
measure: Number of on demand boluses infused, indication of on demand bolus administration
timeFrame: during operation
measure: Rating of anesthesia conditions
timeFrame: during operation
measure: Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.
timeFrame: during operation and an average of 4 weeks thereafter
measure: Number of correct estimates of group randomization by surgeons
timeFrame: directly after operation
Other outcomes:
measure: length of stay ICU/PACU
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: need for re-intubation
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: post-operative surgical complications
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: VAS-scores
timeFrame: 24-hours post operation
measure: Abdominal and thoracic insufflation pressures
timeFrame: During operation
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: Noord-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Markus W Hollmann, prof
role: STUDY_CHAIR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Denise P Veelo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Veelo DP, Gisbertz SS, Binnekade JM, Hannivoort RA, Bosman JA, Geerts BF, Blobner M, van Berge Henegouwen MI, Hollmann MW. On-demand versus continuous rocuronium infusion for deep neuromuscular relaxation in patients undergoing thoraco-laparoscopic esophagectomy: a randomized-controlled clinical trial (DEPTH). Can J Anaesth. 2019 Sep;66(9):1062-1074. doi: 10.1007/s12630-019-01373-0. Epub 2019 Apr 25.
citation: Veelo DP, Gisbertz SS, Hannivoort RA, van Dieren S, Geerts BF, van Berge Henegouwen MI, Hollmann MW. The effect of on-demand vs deep neuromuscular relaxation on rating of surgical and anaesthesiologic conditions in patients undergoing thoracolaparoscopic esophagectomy (DEPTH trial): study protocol for a randomized controlled trial. Trials. 2015 Aug 5;16:331. doi: 10.1186/s13063-015-0849-0.