Clinical trial NCT05773807: Effect of Bispectral Index Monitoring (BIS) on Body Movement of Outpatients Undergoing Gastroscopy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroscopy
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2023-03-17
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome is the incidence of moderate to severe body movement during gastroscopy
timeFrame: The time during gastroscopy, an average of 15 minutes
Secondary outcomes:
measure: The time of gastroscopy
timeFrame: The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes
measure: Endoscopist satisfaction scores
timeFrame: At the end of the gastroscopy
measure: The incidence of hypotension
timeFrame: The time during gastroscopy, an average of 15 minutes
measure: The incidence of bradycardia
timeFrame: The time during gastroscopy，an average of 15 minutes
measure: The incidence of hypoxemia
timeFrame: The time during gastroscopy，an average of 15 minutes
measure: The propofol consumption during gastroscopy
timeFrame: From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes
measure: The time to awake
timeFrame: The time from the end of gastroscopy to the observer's assessment alert sedation equal to 5, up to 30 minutes
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: China, Sichuan West China Hospital
name: Chunling Jiang, PhD
role: STUDY_CHAIR
References: