Overview

CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity

Status:
Completed

Trial end date:
2015-01-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to investigate if a deep neuromuscular block with a continuous infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with reversal of neuromuscular blockade with sugammadex results in improved surgical conditions for the surgeon and/or improved post-operative respiratory function for the patients as compared to a standard technique with an intubation dose of rocuronium and top-ups as needed to maintain a neuromuscular blockade with a train of four (TOF) count of 1-2 and reversal of neuromuscular blockade with neostigmine/glycopyrrolate. Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium and reversal with sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ziekenhuis Oost-Limburg

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Glycopyrrolate
Neostigmine
Rocuronium

Criteria

Inclusion Criteria:

1. Able to give written informed consent

2. American Society of Anaesthesiologists class I, II or III

3. Obese or morbid obese as defined by BMI > 30 and >40 kg/m2 respectively

Exclusion Criteria:

1. Neuromuscular disorders

2. Allergies to, or contraindication for muscle relaxants, neuromuscular reversing
agents, anaesthetics, narcotics

3. Malignant hyperthermia

4. Pregnancy or lactation

5. Renal insufficiency defined as serum creatinine of 2x the upper normal limit,
glomerular filtration rate < 60ml/min, urine output of < 0.5ml/kg/h for at least 6h

6. Chronic obstructive pulmonary disease GOLD classification 2 or higher.

7. Clinical, radiographic or laboratory findings suggesting upper or lower airway
infection

8. Congestive heart failure.

9. Pickwick syndrome

10. Psychiatric illness inhibiting cooperation with study protocol or possibly obscuring
results