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

Abstract

BackgroundDeep muscle relaxation has been shown to facilitate operating conditions during laparoscopic surgery. Minimally invasive esophageal surgery is a high-risk procedure in which the use of deep neuromuscular block (NMB) may improve conditions in the thoracic phase as well. Neuromuscular antagonists can be given on demand or by continuous infusion (deep NMB). However, the positioning of the patient often hampers train-of-four (TOF) monitoring. A continuous infusion thus may result in a deep NMB at the end of surgery. The use of neostigmine not only is insufficient for reversing deep NMB but also may be contraindicated for this procedure because of its cholinergic effects. Sugammadex is an effective alternative but is rather expensive. This study aims to evaluate the use of deep versus on-demand NMB on operating, anaesthesiologic conditions, and costs in patients undergoing a two- or three-phase thoracolaparoscopic esophageal resection.Methods/DesignWe will conduct a single-center randomized controlled double-blinded intervention study. Sixty-six patients undergoing a thoracolaparoscopic esophageal resection will be included. Patients will receive either continuous infusion of rocuronium 0.6 mg/kg per hour (group 1) or continuous infusion of NaCl 0.9 % 0.06 ml/kg per hour (group 2). In both groups, on-demand boluses of rocuronium can be given (open-label design).The primary aim of this study is to compare the surgical rating scale (SRS) during the abdominal phase. Main secondary aims are to evaluate SRS during the thoracic phase, to evaluate anesthesiologic conditions, and to compare costs (in euros) associated with use of rocuronium, sugammadex, and duration of surgery.DiscussionThis study is the first to evaluate the benefits of deep neuromuscular relaxation on surgical and anaesthesiologic conditions during thoracolaparoscopic esophageal surgery. This surgical procedure is unique because it consists of both an abdominal phase and a thoracic phase taking place in different order depending on the subtype of surgery (a two- or three-stage transthoracic esophagectomy). In addition, possible benefits associated with deep NMB, such as decrease in operating time, will be weighed against costs.Trial registrationEuropean Clinical Trials Database (EudraCT) number: 2014-002147-18 (obtained 19 May 2014)ClinicalTrials.gov: NCT02320734 (obtained 18 Dec. 2014)

On-demand versus continuous rocuronium infusion for deep neuromuscular relaxation in patients undergoing thoraco-laparoscopic esophagectomy: a randomized-controlled clinical trial (DEPTH)

“…The rationale and design of this study have been described in detail elsewhere. 14 No changes in the design were made after the start of the trial, other than an adjustment in the sugammadex dose (as described earlier). 14 All adults undergoing a thoraco-laparoscopic esophagectomy (i.e., McKeown or Ivor Lewis variant) at the Academic Medical Center, Amsterdam, The Netherlands were eligible for inclusion.…”

“…The study protocol has been previously described in detail. 14 Briefly, after induction of anesthesia, a rocuronium infusion was started (0.60 mgÁkg -1 Áhr -1 ) in patients of the intervention group and a saline infusion (0.9% NaCl, 0.06 mLÁkg -1 Áhr -1 ) in patients of the control group. Extra doses of open-label rocuronium 0.30 mgÁkg -1 (i.e., on-demand) could be requested by either surgeon or anesthesiologist in both groups for the following indications: high peak inflation pressure ([ 35 mmHg), high abdominal ([15 mmHg) and/or thoracic ([8 mmHg) insufflation pressures, as well as movement, breathing, or straining of the patient.…”

“…All patients received standardized care preoperatively and postoperatively according to an enhanced recovery after surgery (ERAS) pathway. 14,17 All procedures were undertaken at our tertiary teaching hospital with a volume of approx. 150-200 esophagectomies per year where two senior surgeons and a surgical fellow are present during the procedure.…”

“…Either a two-stage thoraco-laparoscopic esophagostomy (Ivor Lewis procedure) or a three-stage thoracolaparoscopic esophagostomy (McKeown procedure) was chosen depending on the tumour location. [14][15][16][17][18] Laparoscopy (in supine position) was performed at a maximum insufflation pressure of 15 mmHg. Thoracoscopy (in prone position) was done with a maximum insufflation pressure of 6-8 mmHg.…”

Feasibility of Optical Coherence Tomography (OCT) for Intra-Operative Detection of Blood Flow during Gastric Tube Reconstruction

“…Perfusion deficiency of the gastric tube is seen as the major risk factor to develop these complications, which, in turn, correlate with high morbidity, IC-unit stay, high costs in healthcare and decreased quality of life [ 3 ]. Monitoring perfusion would allow surgeons to make different choices in their surgical design [ 4 ] and, if needed, involve anesthesiology interventions to optimize perfusion by the use of fluid or medication [ 5 ]. Consequently, intra-operative perfusion monitoring could potentially aid in achieving better patient outcomes after surgery and in decreasing complications and mortality.…”