Phase 4
N=60
CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity
Obesity · Laparoscopic Gastric Bypass Surgery · Surgical Conditions · Respiratory Function · Cerebral Tissue Oxygenation
Bottom Line
View on ClinicalTrials.gov: NCT01748643 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Subjective Evaluation of the View on the Operating Field by the Surgeon — 4.2; 3.9 units on a scale — p=0.16
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- deep neuromuscular blockade with rocuronium, reversal with sugammadex (Drug); normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ziekenhuis Oost-Limburg
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Evaluation of the View on the Operating Field by the Surgeon |
4.2; 3.9 | 0.16 |
| PRIMARY Number of Intra-abdominal Pressure Rises > 18cmH2O |
0.2; 0.3 | 0.69 |
| PRIMARY Duration of Surgery |
61.3; 70.6 | 0.07 |
| SECONDARY Peak Expiratory Flow |
51.3; 51.5 | 0.97 |
| SECONDARY Forced Expiratory Volume in 1 Second |
45.2; 48.8 | 0.64 |
| SECONDARY Forced Vital Capacity |
51.9; 49.0 | 0.58 |
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.
Eligibility Criteria
Inclusion Criteria
- Able to give written informed consent
- American Society of Anaesthesiologists class I, II or III
- Obese or morbid obese as defined by BMI > 30 and >40 kg/m2 respectively
Exclusion Criteria
- Neuromuscular disorders
- Allergies to, or contraindication for muscle relaxants, neuromuscular reversing agents, anaesthetics, narcotics
- Malignant hyperthermia
- Pregnancy or lactation
- 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
- Chronic obstructive pulmonary disease GOLD classification 2 or higher.
- Clinical, radiographic or laboratory findings suggesting upper or lower airway infection
- Congestive heart failure.
- Pickwick syndrome
- Psychiatric illness inhibiting cooperation with study protocol or possibly obscuring results
Data sourced from ClinicalTrials.gov (NCT01748643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.