Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy

NCT02320734 | Completed Phase 4 DMC

• 3 other identifiers: 2014-2112014-002147-18MISP51412
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromuscular Block; Esophageal Cancer; Surgery

Keywords

surgical rating scale; neuromuscular relaxation; Anaesthesia; minimally invasive esophagectomy

Outcome Measures

Primary Outcomes (1)

• Rating of surgical conditions (SRS) during the abdominal phase of the operation.

  during operation

Secondary Outcomes (5)

• 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

• Rating of anesthesia conditions

  during operation

• 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

• Number of correct estimates of group randomization by surgeons

  directly after operation

Other Outcomes (5)

• length of stay ICU/PACU

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• need for re-intubation

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

• post-operative surgical complications

  participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Study Arms (2)

deep neuromuscular relaxation

ACTIVE COMPARATOR

continuous infusion of rocuronium 0.6 mg/kg/hr (group 1). On demand bolus rocuronium can be given if demanded by anesthesiologist or surgeon

Drug: Rocuronium

on demand neuromuscular relaxation

NO INTERVENTION

continuous infusion of NaCl 0.9% 0.06 ml/kg/hr (group 2) On demand bolus of Rocuronium will be given when demanded by anesthesiologist or surgeon.

Interventions

Rocuronium DRUG

Rocuronium given continuously to reach deep neuromuscular block

Also known as: Esmeron

deep neuromuscular relaxation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients, undergoing elective thoraco-laparoscopic esophageal resection (either Ivor Lewis or McKeown variant)
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Academic Medical Center

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 31025258 DERIVED

• 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.

  PMID: 26242177 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Rocuronium

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Markus W Hollmann, prof

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  STUDY CHAIR

• Denise P Veelo, MD, PhD

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 12, 2014
• First Posted: December 19, 2014
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 19, 2016

Record last verified: 2016-09

Locations

NL (1)