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

Not Applicable

Completed

• Conditions: Gastroscopy
• Interventions: Other: Bispectral index; Other: Observer's assessment alert Sedation; Procedure: Gastroscopy; Drug: Propofol

• Registration Number: NCT05773807
• Lead Sponsor: West China Hospital

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Study First Submitted: 2023-02-20
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-15
• Last Update Submitted: 2023-03-15
• Study First Posted: 2023-03-17
• Last Update Posted: 2023-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIS group	Bispectral index	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.
BIS group	Gastroscopy	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.
OAAS/S group	Observer's assessment alert Sedation	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.
OAAS/S group	Gastroscopy	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.
BIS group	Propofol	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.
OAAS/S group	Propofol	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The time of gastroscopy	The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes	The total time of gastroscopy
The incidence of bradycardia	The time during gastroscopy，an average of 15 minutes	The bradycardia is defined as HR \<50 beats/min
The incidence of hypoxemia	The time during gastroscopy，an average of 15 minutes	The hypoxemia is defined as Spo2\< 90%
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 dissatisfied"and 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 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

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China