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

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

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.

Study Overview

• Status: Completed
• Conditions: Gastroscopy
• Intervention / Treatment: Other: Bispectral index; Procedure: Gastroscopy; Drug: Propofol; Other: Observer's assessment alert Sedation

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 Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BIS group; 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; 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.; Other Names: BIS group; Procedure: Gastroscopy; Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1; Other Names: Electronic Gastroscopy; 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; Other Names: Propofol infusion
Placebo Comparator: OAAS/S group; 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.	Procedure: Gastroscopy; Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1; Other Names: Electronic Gastroscopy; 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; Other Names: Propofol infusion; Other: 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.; Other Names: OAA/S group

What is the study measuring?

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 dissatisfied"and 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

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Study Chair: Chunling Jiang, PhD, China, Sichuan West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 2019-1029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No