Effect of Bispectral Index Monitoring (BIS) on Body Movement of Outpatients Undergoing Gastroscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Gastroscopy

Intervention / Treatment
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* Other: Bispectral index
* Other: Observer's assessment alert Sedation
* Procedure: Gastroscopy
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18≤Age≤65 years old American Society of Anaesthesiologists (ASA) Physical Status of I - II 18≤BMI≤30 kg/m² Outpatient patients who planned to undergo painless gastroscopy under propofol anesthesia Exclusion Criteria: Patients with communication disorders Patients with alcohol and drug abuse or allergic or contraindicated drugs related to this trail Patients who take anti-anxiety, depression or sedative drugs Patients who participated in or were participating in other clinical trials within 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BIS group<br>In the BIS 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 to maintain the BIS value at 45-60. | Other: Bispectral index<br>* 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.<br>* Other names: BIS group;Procedure: Gastroscopy<br>* Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1<br>* Other names: Electronic Gastroscopy;Drug: Propofol<br>* 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<br>* Other names: Propofol infusion;|
| Placebo Comparator: OAAS/S group<br>In the OAAS/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: Observer's assessment alert Sedation<br>* 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.<br>* Other names: OAA/S group;Procedure: Gastroscopy<br>* Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1<br>* Other names: Electronic Gastroscopy;Drug: Propofol<br>* 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<br>* Other names: Propofol infusion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time of gastroscopy | The total time of gastroscopy | The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes | 
| 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 dissatisfiedand 10 indicating very satisfied | At the end of the gastroscopy | 
| 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 | 
| The incidence of bradycardia | The bradycardia is defined as HR <50 beats/min | The time during gastroscopy，an average of 15 minutes | 
| The incidence of hypoxemia | The hypoxemia is defined as Spo2< 90% | The time during gastroscopy，an average of 15 minutes | 
| The propofol consumption during gastroscopy | The total propofol consumption during gastroscopy | From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes | 
| 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 |