Effect of Bispectral Index Monitoring (BIS) on Body Movement of Outpatients Undergoing Gastroscopy
Condition: Gastroscopy
Study type: Interventional

Summary: 
      Patients who meet the enrollment criteria were randomized 1:1 to either the BIS group or the
      OAA/S group.

      In the BIS group, the anesthesiologist set the target controlled infusion（TCI）parameters
      according to the patient's height, weight, gender and age. The initial plasma target
      concentration was set to 1.5 ug/ml, and the target concentration would be increased or
      decreased 0.5 ug/ml every two minutes to maintain the BIS value at 45-60. In the OAA/S group,
      the target concentration would be increased or decreased 0.5 ug/ml every two minutes to
      maintain the OAA/S value at 1 point.
    

Detailed description: 
      Patients who meet the enrollment criteria were randomized 1:1 to either the BIS group or the
      OAA/S group.

      In the BIS group, the anesthesiologist set the target controlled infusion (TCI) parameters
      according to the patient's height, weight, gender and age. The initial plasma target
      concentration was set to 1.5 ug/ml, and the target concentration would be increased or
      decreased 0.5 ug/ml every two minutes to maintain the BIS value at 45-60. In the OAA/S group,
      the target concentration would be increased or decreased 0.5 ug/ml every two minutes to
      maintain the OAA/S value at 1 point.

      Body movement, the time of gastroscopy, endoscopist satisfaction scores to sedation, the
      propofol consumption during gastroscopy and the time to awake were be recorded. In addition,
      the event of the respiration and circulation suppression during the gastroscopy were
      recorded. Atropine 0.3 mg was injected intravenously if bradycardia occurred (heart rate <50
      beats/min), M-hydroxyamine 0.3 mg was injected intravenously if hypotension (mean arterial
      pressure<65 mmHg), Ephedrine 3 mg was injected if bradycardia and hypotension occured.
      Patients would receive face mask-assisted ventilation if the Spo2 dropped below 90% or
      respiratory frequency was lower than 8 breaths/min during the gastroscopy.
    

Intervention name(s): Bispectral index; Observer's assessment alert Sedation; Gastroscopy; Propofol
Intervention type(s): Other; Other; Procedure; Drug
Intervention description(s): In the BIS group, the anesthesiologist set the target controlled infusion (TCI) parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ ml every two minutes to maintain the BIS value at 45-60.; In the OAA/S group, the anesthesiologist set the TCI parameters according to the patient's height, weight, gender and age. The initial plasma target concentration was set to 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ ml every two minutes maintain the OAA/S value at 1 point.; Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1; Propofol infusion was administered under the guidance of the BIS or OAA/S before the gastroscopy, and the infusion was stopped at the end of gastroscopy
Other intervention name(s): BIS group; OAA/S group; Electronic Gastroscopy; Propofol infusion
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention