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

Gastroscopy Clinical Trial

— BIS  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05773807
• Other study ID #: 2019-1029
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: February 15, 2023

Study information

• Verified date: March 2023
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Gastroscopy

Intervention

Other:
• Bispectral 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.
• Observer'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.

Procedure:
• Gastroscopy
Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1

Drug:
• Propofol
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

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

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