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Table 4 Adverse events of anesthesia and sedation

From: Efficacy and safety of remimazolam tosylate for sedation during upper gastrointestinal endoscopy: study protocol for a multicenter randomized controlled trial

Step 1: Was there one or more adverse events associated with this sedation encounter?

No, this form is now complete.

Yes, fill out remainder of form below.

Step 2: Please DESCRIBE the adverse events(s). Check all that apply.

Minimal risk descriptors

Minor risk descriptors

Sentinel risk descriptors

Vomiting/Retching

Oxygen desaturation (75–90%) for <60s

Oxygen desaturation, severe (<75% at any time) or prolonged (<90% for >60s)

Other, specify below

Subclinical respiratory depressiona

Apnea, not prolonged

Apnea, prolonged (>60 s)

Muscle rigidity, myoclonus

Airway obstruction

Cardiovascular collapse/shockg

Hypersalivation

Failed sedatione

Cardiac arrest/absent pulse

Paradoxical responseb

Allergic reaction without anaphylaxis

Recovery agitationc

Bradycardiaf

Prolonged recoveryd

Tachycardiaf

Hypotensionf

Hypertensionf

Seizure

Step 3: Please note the INTERVENTIONS performed to treat the adverse events(s). Check all that apply.

Minimal risk

Minor risk

Moderate risk

Sentinel intervention

No intervention performed

Airway repositioning

Bag valve mask-assisted ventilation

Chest compressions

Other, specify below

Administration of:

Tactile stimulation

Laryngeal mask airway

Tracheal intubation

Additional sedative(s)

or the administration of:

Oral/nasal airway

or the administration of:

Antiemetic

Supplemental oxygen, new or increased

Continuous positive airway pressure (CPAP)

Neuromuscular block

Antihistamine

Antisialogogue

or the administration of:

Pressor/epinephrine

Reversal agents

Atropine to treat bradycardia

Rapid i.v. fluids

Anticonvulsant i.v.

Step 4: Please note the OUTCOME of the adverse events(s). Check all that apply.

Minimal risk outcome

Moderate risk outcome

Sentinel outcome

No adverse outcome

Unplanned hospitalization or escalation of careh

Death

Other, specify below

Permanent neurological deficit

Pulmonary aspiration syndromei

Step 5: Assign a SEVERITY rating to the adverse event(s) associated with this sedation encounter.

If there are any options checked in the Sentinel columns above, then this is a Sentinelj adverse event.

If the most serious option(s) checked above are Moderate risk, then this is a Moderatek risk adverse event.

If the most serious option(s) checked above are Minor risk, then this is a Minorl risk adverse event.

If the most serious option(s) checked above are Minimal risk, then this is a Minimalm risk adverse event.

  1. Additional details (including “other” entries):
  2. Footnotes:
  3. a“Subclinical respiratory depression” is defined as capnographic abnormalities suggesting respiratory depression that do not manifest clinically
  4. b“Paradoxical response” is defined as unanticipated restlessness or agitation in response to sedatives
  5. c“Recovery agitation” is defined as abnormal patient affect or behaviors during the recovery phase that can include crying, agitation, delirium, dysphoria, hallucinations, or nightmares
  6. d“Prolonged recovery” is defined as failure to return to baseline clinical status within 2 h
  7. e“Failed sedation” is defined as inability to attain suitable conditions to humanely perform the procedure
  8. fAlteration in vital signs (bradycardia, tachycardia, hypotension, hypertension) is defined as a change of >25% from baseline.
  9. g“Cardiovascular collapse/shock” is defined as clinical evidence of inadequate perfusion
  10. hExamples of “escalation of care” include transfer from ward to intensive care, and prolonged hospitalization
  11. i“Pulmonary aspiration syndrome” is defined as known or suspected inhalation of foreign material such as gastric contents into the respiratory tract associated with new or worsening respiratory signs
  12. j“Sentinel” adverse events are those critical enough to represent real or serious imminent risk of serious and major patient injury. Once recognized, they warrant immediate and aggressive rescue interventions. Once clinically concluded, they warrant immediate reporting within sedation care systems, and the highest level of peer scrutiny for continuous quality improvement
  13. k“Moderate” adverse events are those that, while not sentinel, are serious enough to quickly endanger the patient if not promptly managed. Once clinically concluded, they warrant timely reporting within sedation care systems, and periodic peer scrutiny for continuous quality improvement
  14. l“Minor” adverse events are those encountered periodically in most sedation settings and that pose little threat given appropriate sedationist skills and monitoring.
  15. m“Minimal” adverse events are those that alone present no danger of permanent harm to the patient
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