West China Hospital
Chengdu, Sichuan, 610041, China
NCT Number: NCT05773807
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610041, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: BIS group
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.
Other names: OAA/S group
Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1
Other names: Electronic Gastroscopy
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 names: Propofol infusion
Time frame: The time during gastroscopy, an average of 15 minutes
Moderate to severe body movement is defined as the twisting of the patient's body due to the stimulation of the gastroscopy, making it difficult to proceed with the procedure without additional propofol.
Time frame: The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes
The total time of gastroscopy
Time frame: At the end of the gastroscopy
Endoscopist satisfaction scores to sedation during gastroscopy were obtained at the end of the procedure, using a 11-point Likert scale, with 0 indicating "very dissatisfied"and 10 indicating "very satisfied"
Time frame: The time during gastroscopy, an average of 15 minutes
The hypotension is defined as the blood pressure<90/60 mm Hg or 20% lower at baseline
Time frame: The time during gastroscopy,an average of 15 minutes
The bradycardia is defined as HR <50 beats/min
Time frame: The time during gastroscopy,an average of 15 minutes
The hypoxemia is defined as Spo2< 90%
Time frame: From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes
The total propofol consumption during gastroscopy
Time frame: The time from the end of gastroscopy to the observer's assessment alert sedation equal to 5, up to 30 minutes
The time to awake is defined as from the end of gastroscopy to the observer's assessment alert sedation equal to 5
West China Hospital
Other
Effect of Bispectral Index Monitoring and Observer's Assessment Alert Sedation Scale (OAA/S) Guided Sedation on Body Movement of Outpatients Undergoing Gastroscopy: a Randomized Study
Acronym: BIS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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