Gastroscopy
Conditions
Brief 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.
Interventions
OTHERBispectral index
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.
OTHERObserver's assessment alert Sedation
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.
PROCEDUREGastroscopy
Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1
DRUGPropofol
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
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is the incidence of moderate to severe body movement during gastroscopy | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopist satisfaction scores | 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 dissatisfiedand 10 indicating very satisfied |
| The incidence of hypotension | 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 |
| The incidence of bradycardia | The time during gastroscopy，an average of 15 minutes | The bradycardia is defined as HR \<50 beats/min |
| The time of gastroscopy | The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes | The total time of gastroscopy |
| The propofol consumption during gastroscopy | From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes | The total propofol consumption during gastroscopy |
| The time to awake | 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 |
| The incidence of hypoxemia | The time during gastroscopy，an average of 15 minutes | The hypoxemia is defined as Spo2\< 90% |
Countries
China
Outcome results
None listed