Effect of Neuromuscular Reversal With Sugammadex on Postoperative Recovery Profile (Neuropa)

Leiden University Medical Center (LUMC)

Status and phase

Completed

Phase 4

Conditions

Postoperative Respiratory Condition

Treatments

Drug: Neostigmine

Drug: Sugammadex

Study type

Interventional

Funder types

Other

Identifiers

NCT02243943

NL34186.058.10 (Other Identifier)

Details and patient eligibility

About

Suboptimal reversal of neuromuscular blockage after surgery is possibly related to unfavorable postoperative respiratory conditions and elevated pain levels. Rapid and complete reversal of neuromuscular block was not possible untill sugammadex was discovered. The investigators hyposthesise that reversal with sugammadex leads to favorable postoperative respiratory conditions and less pain compared to reversal with neostigmine.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18 years
- BMI < 35
-ASA class I- III
-Patients scheduled for surgery requiring general anesthesia with the use of NMBA's
- Patients with ability to give oral and written informed consent

Exclusion criteria

Failure to meet the inclusion criteria
- -Known or suspected neuromuscular disorders impairing neuromuscular function
- -Allergies to muscle relaxants, anesthetics or narcotics
A (family) history of malignant hyperthermia
- -Women who are or may be pregnant or are currently breast feeding
- -Contraindications for the use of neostigmine
Intestinal obstruction,
COPD GOLD 4
- -Abnormal heart rhythm (eg. bradycardia: < 40/min);
- -Surgery requiring neuraxial anesthesia / analgesia
- -Preoperative cognitive dysfunction or mental disabilities
- -Preexistent significant pulmonary disease with preoperative SpO2 < 90%
- -Preoperative ICU treatment / intubation (ICU patient);
- -Need for postoperative ICU treatment or ventilation;