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

S

Sichuan University

Status

Completed

Conditions

Gastroscopy

Treatments

Drug: Propofol
Procedure: Gastroscopy
Other: Bispectral index
Other: Observer's assessment alert Sedation

Study type

Interventional

Funder types

Other

Identifiers

NCT05773807
2019-1029

Details and patient eligibility

About

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.

Full 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.

Enrollment

400 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

400 participants in 2 patient groups, including a placebo group

BIS group
Experimental group
Description:
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.
Treatment:
Other: Bispectral index
Procedure: Gastroscopy
Drug: Propofol
OAAS/S group
Placebo Comparator group
Description:
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.
Treatment:
Other: Observer's assessment alert Sedation
Procedure: Gastroscopy
Drug: Propofol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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