Deep Neuromuscular Relaxation in Patients for Thoraco-laparoscopic Esophagectomy

Surgery Clinical Trial

— DEPTH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320734
• Other study ID #: 2014-211
• Secondary ID: 2014-002147-18MI
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2014
• Last updated: September 16, 2016
• Start date: February 2015
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Neuromuscular Block
• Surgery

Intervention

Drug:
• Rocuronium
Rocuronium given continuously to reach deep neuromuscular block

Locations

Country	Name	City	State
Netherlands	Academic Medical Center	Amsterdam	Noord-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of stay ICU/PACU		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	No
Other	need for re-intubation		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Other	post-operative surgical complications		participants will be followed for the duration of hospital stay, an expected average of 4 weeks	Yes
Other	VAS-scores		24-hours post operation	No
Other	Abdominal and thoracic insufflation pressures		During operation	No
Primary	Rating of surgical conditions (SRS) during the abdominal phase of the operation.		during operation	No
Secondary	Rating of SRS during thoracic phase of the operation.		during operation	No
Secondary	Number of on demand boluses infused, indication of on demand bolus administration		during operation	No
Secondary	Rating of anesthesia conditions	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	during operation	Yes
Secondary	Costs (euro's) associated with use of Rocuronium, Sugammadex, operation time and length of stay ICU.	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(%).	during operation and an average of 4 weeks thereafter	No
Secondary	Number of correct estimates of group randomization by surgeons	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.	directly after operation	No