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Trial · NCT06207344

Registered outcomes15

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

ListOutcomeTime frameDescription
PrimaryTime to open eyes after anesthetics withdrawalFrom time of anesthetic withdrawal to the first time of the patient open his or her eyes, assessed up to 2 hour.The first time to open eyes after anesthetics withdrawal.
SecondaryIncidence of deliriumFrom time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
The Richmond Agitation-Sedation Scale (RASS) will be used to assess the incidence of delirium. RASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 \[combative\]), one level to denote a calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5). The scores of +2, +3, and +4 are defined as delirium.
SecondaryIncidence of nausea and vomitingFrom time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
The severity of nausea and vomiting will be evaluated by visual analogue scale (VAS): a 10 cm ruler was used as a scale, one end (0 points) indicated no nausea and vomiting, and the other end was 10 cm, indicating the most severe nausea and vomiting that was unbearable (1\~4 was mild, 5\~6 was moderate, and 7\~10 was severe).
SecondaryPain levelFrom time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.
Numeric Rating Scale will be used to assess the degree of pain. 0\~10 is used to represent different degrees of pain: 0 is no pain, 1\~3 is mild pain (the pain does not affect sleep), 4\~6 is moderate pain (mildly affects sleep), 7\~9 is severe pain (unable to fall asleep or wakes up from sleep), and 10 is severe pain.
SecondaryIncidences of other side effectsFrom time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.Any unquestioned side effects will be recorded, such non-planned intensive care unit transfer, unplanned reoperation, unplanned reintubation, etc.
SecondaryDrugs and their dosageFrom time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.These drugs and their dosage will be recorded, such as muscle relaxant antagonism, antiemetic drugs, and analgesic drugs.
SecondaryQoR-40 scoresPostoperative day 1 and 3.
QoR-40 scores will be used to assess the quality of recovery. The questionnaire consists of five subscales: emotional status (9 items), physical comfort (12 items), psychological support (7 items), physical independence (5 items), and pain (7 items). All the items are rated on a five-point scale ranging from 1 to 5. The initial point and conversion score of each item are calculated. Depending on the question, the best answers may have a score of either 5 or 1. The best answers to positive questions are scored 5, while the best answers to negative questions are assigned the score of 1. The total score of QoR-40 is given by the summation of scores for all items and ranges from 40 to 200. The higher the score, the better is the health status.Citation
SecondaryPostoperative pulmonary complicationsFirst 7 postoperative days
The incidence of postoperative pulmonary complications was assessed according to the Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) definition. The severity of postoperative pulmonary complications was scored on a 0-5 scale.
SecondaryWhite blood cell countPostoperative day 1 and 3.White blood cell count will be used to assess the inflammatory level.
SecondaryNeutrophil ratioPostoperative day 1 and 3.Neutrophil ratio will be used to assess the inflammatory level.
SecondaryLymphocyte ratioPostoperative day 1 and 3.Lymphocyte ratio will be used to assess the inflammatory level.
SecondaryC-reactive proteinPostoperative day 1 and 3.C-reactive protein will be used to assess the inflammatory level.
SecondaryTime for tidal volume of spontaneous breathing over 300 mlFrom time of anesthetic withdrawal to the patient tidal volume of spontaneous breathing over 300 ml, assessed up to 2 hour.Time from anesthetics withdrawal to tidal volume of spontaneous breathing over 300 ml.
SecondaryExtubation timeFrom time of anesthetic withdrawal to the tracheal tube was extubated, assessed up to 2 hour.Time from anesthetics withdrawal to extubation
SecondaryPostanesthesia care unit residence timeFrom time of anesthetic withdrawal to the patient leaving the postanesthesia care unit, assessed up to 2 hour.Time of staying in postanesthesia care unit

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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