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Trial · NCT07902193

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryTime to extubationFrom sugammadex administration to tracheal extubation, assessed up to 60 minutesTime from sugammadex administration to tracheal extubation, in minutes and seconds. Time from end of surgery to extubation will also be recorded.
SecondaryTime from end of surgery to extubationFrom the end of surgery to tracheal extubation, assessed up to 60 minutesTime from the end of surgery to tracheal extubation, in seconds.
SecondaryEmergence agitationOn arrival in the post-anesthesia care unit (PACU) and at 5 and 10 minutes after arrival
Agitation will be assessed with the Richmond Agitation-Sedation Scale (RASS), which ranges from -5 (unarousable) to +4 (combative), with 0 indicating alert and calm; higher scores indicate greater agitation. RASS scores and the incidence of agitation, defined as a RASS score of +1 or higher, will be reported.
SecondaryHeart rateBefore the start of emergence; every minute for the first 10 minutes and at 15 minutes after the start of emergence; and at 1, 5 and 10 minutes after arrival in the post-anesthesia care unit (PACU)Heart rate in beats per minute.
SecondaryBlood pressureBefore the start of emergence; every 5 minutes up to 15 minutes after the start of emergence; and at 1, 5 and 10 minutes after arrival in the post-anesthesia care unit (PACU)Systolic, diastolic and mean arterial blood pressure in millimeters of mercury (mmHg)..
SecondaryPeripheral oxygen saturation (SpO2)Before the start of emergence; every minute for the first 10 minutes and at 15 minutes after the start of emergence; and at 1, 5 and 10 minutes after arrival in the post-anesthesia care unit (PACU)Peripheral oxygen saturation measured by pulse oximetry, in percent.
SecondaryIncidence of postoperative nausea and vomitingFrom tracheal extubation to 10 minutes after arrival in the post-anesthesia care unit (PACU)Number of participants with postoperative nausea and/or vomiting.
SecondaryIncidence of bradycardiaFrom sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)Number of participants with bradycardia, defined as a heart rate below the age-specific lower limit or a decrease of more than 20% from baseline.
SecondaryIncidence of laryngospasmFrom sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)Number of participants with laryngospasm.
SecondaryIncidence of anaphylaxisFrom sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)Diagnosed according to the NIAID/FAAN clinical criteria and graded by Ring-Messmer.
SecondaryIncidence of skin rashFrom sugammadex administration to 10 minutes after arrival in the post-anesthesia care unit (PACU)Number of participants with skin rash.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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