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Completed

NCT Number: NCT05773807

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, 610041, China

About this 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.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18≤Age≤65 years old
  • American Society of Anaesthesiologists (ASA) Physical Status of I - II
  • 18≤BMI≤30 kg/m²
  • Outpatient patients who planned to undergo painless gastroscopy under propofol anesthesia

Exclusion criteria

  • Patients with communication disorders
  • Patients with alcohol and drug abuse or allergic or contraindicated drugs related to this trail
  • Patients who take anti-anxiety, depression or sedative drugs
  • Patients who participated in or were participating in other clinical trials within 3 months

Treatment and study plan

Bispectral index

Other

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

Observer's assessment alert Sedation

Other

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

gastroscopy

Procedure

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

Other names: Electronic Gastroscopy

Propofol

Drug

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

Primary outcomes

  1. The primary outcome is the incidence of moderate to severe body movement during gastroscopy

    Time frame: The time during gastroscopy, an average of 15 minutes

    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.

Secondary outcomes

  1. The time of gastroscopy

    Time frame: The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes

    The total time of gastroscopy

  2. Endoscopist satisfaction scores

    Time frame: At the end of the gastroscopy

    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"

  3. The incidence of hypotension

    Time frame: The time during gastroscopy, an average of 15 minutes

    The hypotension is defined as the blood pressure<90/60 mm Hg or 20% lower at baseline

  4. The incidence of bradycardia

    Time frame: The time during gastroscopy,an average of 15 minutes

    The bradycardia is defined as HR <50 beats/min

  5. The incidence of hypoxemia

    Time frame: The time during gastroscopy,an average of 15 minutes

    The hypoxemia is defined as Spo2< 90%

  6. The propofol consumption during gastroscopy

    Time frame: From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes

    The total propofol consumption during gastroscopy

  7. The time to awake

    Time frame: The time from the end of gastroscopy to the observer's assessment alert sedation equal to 5, up to 30 minutes

    The time to awake is defined as from the end of gastroscopy to the observer's assessment alert sedation equal to 5

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study 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

Acronym: BIS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 17, 2023
Registry last updated
Mar 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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