NCT05773807

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Gastroscopy

Interventions

Type	Name	Description
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	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

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-02-15
• Completion: 2023-02-15
• First posted: 2023-03-17
• Last updated: 2023-03-17

Locations

1 site across 1 country: China