Methods |
Allocation: randomized Intervention model: parallel assignment Masking: double‐blind (participant, investigator) Primary purpose: treatment |
Participants |
Enrolment: 100 Inclusion criteria:
Age 18 years
Body mass index (BMI) < 35
American Society of Anesthesiologists (ASA) class I to III
Scheduled for surgery requiring general anaesthesia with a neuromuscular blocking agent
Ability to give oral and written informed consent
Exclusion criteria:
Failure to meet inclusion criteria ‐ known or suspected neuromuscular disorders impairing neuromuscular function; allergy to muscle relaxants, anaesthetics, or narcotics
(Family) history of malignant hyperthermia; women who are or may be pregnant or are currently breastfeeding; contraindications for use of neostigmine; intestinal obstruction, chronic obstructive pulmonary disease (COPD), Global Initiative for Obstrutive Lung Disease (GOLD) 4; abnormal heart rhythm (e.g. bradycardia: < 40/min); surgery requiring neuraxial anaesthesia/analgesia; preoperative cognitive dysfunction or mental disabilities; preexistent significant pulmonary disease with preoperative peripheral oxygen saturation (SpO2) < 90%; preoperative intensive care unit (ICU) treatment/intubation (ICU patient);need for postoperative ICU treatment or ventilation
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Interventions |
Sugammadex 2 to 4 mg/kg Neostigmine 1.0 to 2.5 mg and atropine 0.5 to 1.0 mg |
Outcomes |
Primary outcome measures:
Secondary outcome measures:
Pain [Time Frame: 45 minutes] [Designated as safety issue: no] Using the 1 to 10 numerical rating scale
Sedation [Time Frame: 45 minutes] [Designated as safety issue: no] Using Leiden observer alertness score
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Notes |
This study has been completed. Based on personal correspondence with the last trial author, we became aware of preliminary results, published as a letter (September 2016), after our last search (2 May 2016). These data will be published in the next updated version of this review |