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Effect of neuromuscular blockade reversal with sugammadex on oxygenation, pain and arousal states in the post-anesthesia care unit

Effect of neuromuscular blockade reversal with sugammadex on oxygenation, pain and arousal states in the post-anesthesia care unit

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26051
Enrollment
100
Registered
2015-08-11
Start date
2014-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sugammadex, Train of four ratio, Respiration, Post operative

Interventions

According to the randomization list the patient will receive at the end of the surgery sugammadex 2mg/kg or neostigmine 2.5 mg + atropine 1 mg at a NMB level of TOF>0

Sponsors

Leiden University Medical Center (LUMC)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - Age >18 years - Body mass index < 35 kg/m2 - ASA class I-III - Patients scheduled for elective surgery requiring anesthesia with the use of neuromuscular blocking agents.

Exclusion criteria

Exclusion criteria: - Known or suspected neuromuscular disorder impairing neuromuscular function - Allergie to muscle relaxants, anesthesics or narcotics. - A (family) history of malignant hyperthermia - Women who are or may be pregnant or are currently breast feeding - Contraindication for the use of neostigmine (intestinal obstruction, COPD GOLD 4 or abnormal heart rhythm) - 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 - Renal insufficiency (GFR<30 mL/min or oligura < 0.5 mg/kg/h)

Design outcomes

Primary

MeasureTime frame
Postoperative SpO2 level obtained at 2-min interval for 45 minutes and the need for supplemental oxygen

Secondary

MeasureTime frame
Pain, respiratory rate, sedation and lowest TOF ratio

Contacts

Public ContactM Boon

LUMC, Anesthesiology, P5, Albinusdreef 2

m.boon@lumc.nl+31 (0)71 5299891

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)