GastroscopyBISNCT05773807
Effect of Bispectral Index Monitoring (BIS) on Body Movement of Outpatients Undergoing Gastroscopy
A study testing Bispectral index, Observer's assessment alert Sedation and Gastroscopy in people with Gastroscopy, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroscopy
- What is being tested?
- Bispectral index, Observer's assessment alert Sedation and Gastroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Bispectral index, Observer's assessment alert Sedation, Gastroscopy, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bispectral indexOther
Also called BIS 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 1.5ug/ml, and the target concentration would be increased or decreased 0.5ug/ ml every two minutes to maintain the BIS value at 45-60.
Observer's assessment alert SedationOther
Also called OAA/S group
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.
GastroscopyProcedure or surgery
Also called Electronic Gastroscopy
Gastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1
PropofolDrug
Also called Propofol infusion
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
| Study group | Role | What they receive |
|---|---|---|
| BIS group | Experimental | 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. Receives: Other: Bispectral index; Procedure: Gastroscopy; Drug: Propofol |
| OAAS/S group | Placebo comparator | 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. Receives: Other: Observer's assessment alert Sedation; Procedure: Gastroscopy; Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The time during gastroscopy, an average of 15 minutes
Secondary outcomes (7)
The time of gastroscopy
The total time of gastroscopy
Measured: 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"
Measured: 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
Measured: The time during gastroscopy, an average of 15 minutes
The incidence of bradycardia
The bradycardia is defined as HR <50 beats/min
Measured: The time during gastroscopy，an average of 15 minutes
The incidence of hypoxemia
The hypoxemia is defined as Spo2< 90%
Measured: The time during gastroscopy，an average of 15 minutes
The propofol consumption during gastroscopy
The total propofol consumption during gastroscopy
Measured: 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
Measured: The time from the end of gastroscopy to the observer's assessment alert sedation equal to 5, up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2023
- Study start1 Jan 2022
- Primary completion15 Feb 2023
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroscopyStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunling Jiang, West China Hospital
- Investigators
- Chunling Jiang, PhD, Study chair, China, Sichuan West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05773807
- Sponsor's protocol ID
- 2019-1029
- Acronym
- BIS
- Status last verified
- Mar 2023
- First submitted
- 20 Feb 2023
- Last updated
- 17 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05773807
- Acronym / sponsor ID
- BIS / 2019-1029
- Conditions
- Gastroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 17 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BIS group | Experimental | Other: Bispectral index, Procedure: Gastroscopy, Drug: PropofolIn 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. |
| OAAS/S group | Placebo comparator | Other: Observer's assessment alert Sedation, Procedure: Gastroscopy, Drug: PropofolIn 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bispectral indexAlso: BIS groupIn 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 | BIS group |
| Observer's assessment alert SedationAlso: OAA/S groupIn 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 | OAAS/S group |
| GastroscopyAlso: Electronic GastroscopyGastroscopy would be performed when the BIS value was 45-60 or the OAA/S score was 1 | Procedure or surgery | BIS group, OAAS/S group |
| PropofolAlso: Propofol infusionPropofol 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 | Drug | BIS group, OAAS/S group |
Primary outcome
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.
7 secondary outcomes
The time of gastroscopy
Time frame: The time from gastroscope insertion to gastroscope withdraw, an average of 15 minutes
Endoscopist satisfaction scores
Time frame: At the end of the gastroscopy
The incidence of hypotension
Time frame: The time during gastroscopy, an average of 15 minutes
The incidence of bradycardia
Time frame: The time during gastroscopy，an average of 15 minutes
The incidence of hypoxemia
Time frame: The time during gastroscopy，an average of 15 minutes
The propofol consumption during gastroscopy
Time frame: From anesthetic induction to discontinuation of propofol infusion, an average of 15 minutes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunling Jiang, PhD study chair
China, Sichuan West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bispectral index, Observer's assessment alert Sedation and Gastroscopy in people with Gastroscopy, run by West China Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.