Gastroscopy Clinical Trial
— BISOfficial title:
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
Verified date | March 2023 |
Source | West China Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 400 |
Est. completion date | February 15, 2023 |
Est. primary completion date | February 15, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. 18=Age=65 years old 2. American Society of Anaesthesiologists (ASA) Physical Status of I - II 3. 18=BMI=30 kg/m² 4. Outpatient patients who planned to undergo painless gastroscopy under propofol anesthesia Exclusion Criteria: 1. Patients with communication disorders 2. Patients with alcohol and drug abuse or allergic or contraindicated drugs related to this trail 3. Patients who take anti-anxiety, depression or sedative drugs 4. Patients who participated in or were participating in other clinical trials within 3 months |
Country | Name | City | State |
---|---|---|---|
China | West China Hospital | Chengdu | Sichuan |
Lead Sponsor | Collaborator |
---|---|
West China Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is the incidence of moderate to severe body movement during gastroscopy | 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. | The time during gastroscopy, an average of 15 minutes | |
Secondary | The time of gastroscopy | The total time of gastroscopy | The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes | |
Secondary | Endoscopist satisfaction scores | 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" | At the end of the gastroscopy | |
Secondary | The incidence of hypotension | The hypotension is defined as the blood pressure<90/60 mm Hg or 20% lower at baseline | The time during gastroscopy, an average of 15 minutes | |
Secondary | The incidence of bradycardia | The bradycardia is defined as HR <50 beats/min | The time during gastroscopy,an average of 15 minutes | |
Secondary | The incidence of hypoxemia | The hypoxemia is defined as Spo2< 90% | The time during gastroscopy,an average of 15 minutes | |
Secondary | The propofol consumption during gastroscopy | The total propofol consumption during gastroscopy | From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes | |
Secondary | The time to awake | The time to awake is defined as from the end of gastroscopy to the observer's assessment alert sedation equal to 5 | The time from the end of gastroscopy to the observer's assessment alert sedation equal to 5, up to 30 minutes |
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