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. 2017 Aug 14;2017(8):CD012763. doi: 10.1002/14651858.CD012763

NCT02243943.

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

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:
  • Mean lowest saturation [Time frame: 45 minutes] [Designated as safety issue: no] Mean saturation is the mean value of beat‐to‐beat Hb‐oxygen saturation measured by finger pulse oximeter, as measured in the first 45 minutes in the recovery room following surgery


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

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