Effect of deep muscle relaxation on surgical conditions during gastric pull-up
- Conditions
- oesophageal carcinomaTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2014-002147-18-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
All patients > 18 years to undergo a thoracolaparoscopic esophageal resection.I
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
Exclusion Criteria
aged < 18 or pregnancy
known allergies for aminosteroid-type muscle relaxants or sugammadex.
Severe kidney dysfunction (GFR < 30), patients on dialysis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to evaluate the use of deep muscle relaxation versus on indication only on surgical and anesthesia conditions in patients for endoscopic esophageal resection. ;Secondary Objective: 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. ;Primary end point(s): Rating of surgical conditions (SRS) during the abdominal phase of the operation.;Timepoint(s) of evaluation of this end point: Every 30 minutes during surgery
- Secondary Outcome Measures
Name Time Method Timepoint(s) of evaluation of this end point: For surgical conditions, every 30 minutes, for anesthesiologisc conditions and resucue medication, continuously. For costanalysis at the end of surgical procedure;Secondary end point(s): - Rating of SRS during thoracic phase of the operation. Number of on demand boluses infused, indication of on demand bolus administration,<br>- Rating of anesthesia conditions including: 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. <br>- Cost analysis: amount of rocuronium used (mg); Dose of sugammadex needed (mg), time to reversal, duration of surgery, hypothetical need for need for post-operative ventilation (%).