PainNCT04691076
Effect of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy
A study testing Propofol, Esketamine and Fentanyl in people with Pain and Anesthesia, run by Tianjin Union Medical Center at 1 site in China.
Trial summary
Purpose: 1. To determine the efficacy of low-dose esketamine in painless gastrointestinal endoscopy. 2. To determine the safety of low-dose esketamine in painless gastrointestinal endoscopy. 3. To provide a theoretical basis and new ideas for the application of esketamine as a new drug in perioperative period. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Anesthesia
- What is being tested?
- Propofol, Esketamine and Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Feb 2022
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject's American Society of Anesthesiologists physical status is I-III.
- Subject has no symptoms of allergy to anesthetics.
- Subject has no contraindications for gastrointestinal endoscopy.
- Subject has given written informed consent to participate.
Who cannot join
- Subject's BMI <18 or >30
- Subject has poorly controlled or untreated hypertension.
- Subject has severe ischemic heart disease.
- Subject is an untreated or undertreated patient with hyperthyroidism.
- Subject has used drugs that affect their central nervous system.
- .Subject has mental illness.
Show all 9Show fewer
- .Subject has epilepsy.
- .Subject has a history of chronic pain.
- .Subject is pregnant or breast-feeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Union Medical Center
Tianjin, 300131
Tao Yang, Master, 18920802290 ext. +86-10, yangtao@nankai.edu.cn
About this study
Official title: Efficacy and Safety of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy and Polypectomy
Purpose: 1. To determine the efficacy of low-dose esketamine in painless gastrointestinal endoscopy. 2. To determine the safety of low-dose esketamine in painless gastrointestinal endoscopy. 3. To provide a theoretical basis and new ideas for the application of esketamine as a new drug in perioperative period.
Read the detailed description
Keeping spontaneous breathing anesthesia can provide patients with comfortable diagnosis and treatment experience during gastrointestinal endoscopy, which is a vital prerequisite for the large-scale development of this operation as well as the early screening and treatment of gastrointestinal malignancies. Clinically, fentanyl combined with propofol is the most commonly used anesthesia regimen for the painless gastroscopy, however its high incidence of respiratory and circulatory depression will threaten the safety of patients. Instead, esketamine has a good action in anesthesia and analgesics, a slighter respiratory depression, as well as with a remarkable improvement in adverse effects than ketamine. What has already been proved is that low- dose of esketamine can remarkably reduce the dosage of propofol during endoscopic retrograde cholangiopancreatography; In our pilot study, we found that not only the incidence of respiratory depression was significantly lower than that of fentanyl during endoscopic polypectomy, but also the dosage of propofol was reduced at the same time,suggesting that esketamine may have a potential superiority in the painless gastrointestinal endoscopy.Our project plans to collect the patients who have received painless gastroscopy and polypectomy in the hospital, and use a target-controlled infusion (TCI) of propofol in combination with esketamine, by observing the total dose of propofol , the time of recovery and the length of hospital stay, the satisfaction of patients and endoscopists, drug side effects,adverse events of respiratory and circulatory system and other indicators ,to evaluate the efficacy and safety of this anesthetic scheme.
- Conditions
- Pain, Anesthesia
- Keywords
- Esketamine; Gastrointestinal endoscopy; Analgesia; Sedation; Respiratory depression
- Medical subject headings
- Pain, Agnosia, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Propofol is administered by target-controlled infusion
EsketamineDrug
Esketamine is intravenously administrated
FentanylDrug
Fentanyl is intravenously administrated
| Study group | Role | What they receive |
|---|---|---|
| Propofol/Esketamine sedation | Experimental | Propofol target-controlled infusion is performed first,when the infusion concentration reaches 1.5μg/ml,esketamine 0.15mg/kg is injected intravenously;then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration, the corresponding increase of esketamine is 0.05mg/kg; the total dose of esketamine used in surgery shall not exceed 0.5mg/kg. Receives: Drug: Propofol; Drug: Esketamine |
| Propofol/Fentanyl sedation | Active comparator | Propofol target-controlled infusion is performed first.When the infusion concentration reaches 1.5μg/ml, fentanyl 0.6μg/kg is injected intravenously; then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration,the corresponding increase of fentanyl is 0.2ug/kg; the total dose of fentanyl used in surgery shall not exceed 1.2ug/kg. Receives: Drug: Propofol; Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative propofol Consumption
Total amount of propofol administered intraoperatively
Measured: intraoperative
Secondary outcomes (5)
The incidence of adverse events in pulmonary and circulatory systems
Pulmonary incidents include:Decreased blood oxygen saturation (SpO2 drops to 75%~90%, duration <60s);Severe decrease in blood oxygen saturation (SpO2<90%, duration>60s; or SpO2<75%);Obstruction of the airways occurs and requires the use of jaw manipulation or emergency airway equipment.
Cardiovascular incidents include:
Bradycardia or tachycardia; Arterial blood pressure increased or decreased by more than 20% of the baseline; Other matters requiring urgent attention.
Measured: During the operation
Time of recovery, post-anaesthesia care unit and discharge from hospital
When the patient is successfully resuscitated,record the time in post-anaesthesia care unit and the time when the discharge standards are met.
Measured: procedure ( the end of endoscopy removal)
The incidence of side effects of esketamine
Record the adverse effects of esketamine such as dizziness, nausea, etc.
Measured: Intraoperative
The number of patients'body movement during operation
Record the patient's body movement during the operation, which reflects the level of sedation.
Measured: During the operation
The satisfaction of the endoscopist and patient
Patients fill out questionnaires before and after surgery to record pain, sedation levels, and side effects (such as nausea and dizziness) to assess their satisfaction,meanwhile,telephone calls can be made one day after the surgery to evaluate their postoperative satisfaction.In addition, the satisfaction of the endoscopist with the sedation level could also recorded on a questionnaire after the operation.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Dec 2020
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Union Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tao Yang, Principal investigator, Tianjin Union Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691076
- Sponsor's protocol ID
- TYang001
- Status last verified
- Dec 2020
- First submitted
- 29 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose Esketamine Combined With Target-controlled Infusion of Propofol for Painless Gastrointestinal Endoscopy and Polypectomy
- ClinicalTrials.gov ID
- NCT04691076
- Acronym / sponsor ID
- TYang001
- Conditions
- Pain, Anesthesia
- Keywords
- Esketamine; Gastrointestinal endoscopy; Analgesia; Sedation; Respiratory depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tianjin Union Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 31 Dec 2020 (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.
Purpose: 1. To determine the efficacy of low-dose esketamine in painless gastrointestinal endoscopy. 2. To determine the safety of low-dose esketamine in painless gastrointestinal endoscopy. 3. To provide a theoretical basis and new ideas for the application of esketamine as a new drug in perioperative period.
Detailed description
Keeping spontaneous breathing anesthesia can provide patients with comfortable diagnosis and treatment experience during gastrointestinal endoscopy, which is a vital prerequisite for the large-scale development of this operation as well as the early screening and treatment of gastrointestinal malignancies. Clinically, fentanyl combined with propofol is the most commonly used anesthesia regimen for the painless gastroscopy, however its high incidence of respiratory and circulatory depression will threaten the safety of patients. Instead, esketamine has a good action in anesthesia and analgesics, a slighter respiratory depression, as well as with a remarkable improvement in adverse effects than ketamine. What has already been proved is that low- dose of esketamine can remarkably reduce the dosage of propofol during endoscopic retrograde cholangiopancreatography; In our pilot study, we found that not only the incidence of respiratory depression was significantly lower than that of fentanyl during endoscopic polypectomy, but also the dosage of propofol was reduced at the same time,suggesting that esketamine may have a potential superiority in the painless gastrointestinal endoscopy.Our project plans to collect the patients who have received painless gastroscopy and polypectomy in the hospital, and use a target-controlled infusion (TCI) of propofol in combination with esketamine, by observing the total dose of propofol , the time of recovery and the length of hospital stay, the satisfaction of patients and endoscopists, drug side effects,adverse events of respiratory and circulatory system and other indicators ,to evaluate the efficacy and safety of this anesthetic scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol/Esketamine sedation | Experimental | Drug: Propofol, Drug: EsketaminePropofol target-controlled infusion is performed first,when the infusion concentration reaches 1.5μg/ml,esketamine 0.15mg/kg is injected intravenously;then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration, the corresponding increase of esketamine is 0.05mg/kg; the total dose of esketamine used in surgery shall not exceed 0.5mg/kg. |
| Propofol/Fentanyl sedation | Active comparator | Drug: Propofol, Drug: FentanylPropofol target-controlled infusion is performed first.When the infusion concentration reaches 1.5μg/ml, fentanyl 0.6μg/kg is injected intravenously; then the dose is adjusted according to the depth of anesthesia and the modified observer's assessment of alert /sedation scale, and propofol target-controlled infusion for every increase of 5μg/ml in concentration,the corresponding increase of fentanyl is 0.2ug/kg; the total dose of fentanyl used in surgery shall not exceed 1.2ug/kg. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject's American Society of Anesthesiologists physical status is I-III.
- Subject has no symptoms of allergy to anesthetics.
- Subject has no contraindications for gastrointestinal endoscopy.
- Subject has given written informed consent to participate.
Key exclusion criteria (9 listed)
- Subject's BMI <18 or >30
- Subject has poorly controlled or untreated hypertension.
- Subject has severe ischemic heart disease.
- Subject is an untreated or undertreated patient with hyperthyroidism.
- Subject has used drugs that affect their central nervous system.
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 |
|---|---|---|
| PropofolPropofol is administered by target-controlled infusion | Drug | Propofol/Esketamine sedation, Propofol/Fentanyl sedation |
| EsketamineEsketamine is intravenously administrated | Drug | Propofol/Esketamine sedation |
| FentanylFentanyl is intravenously administrated | Drug | Propofol/Fentanyl sedation |
Primary outcome
Cumulative propofol Consumption
Time frame: intraoperative
Total amount of propofol administered intraoperatively
5 secondary outcomes
The incidence of adverse events in pulmonary and circulatory systems
Time frame: During the operation
Time of recovery, post-anaesthesia care unit and discharge from hospital
Time frame: procedure ( the end of endoscopy removal)
The incidence of side effects of esketamine
Time frame: Intraoperative
The number of patients'body movement during operation
Time frame: During the operation
The satisfaction of the endoscopist and patient
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
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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.
Tao Yang principal investigator
Tianjin Union Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Propofol, Esketamine and Fentanyl in people with Pain and Anesthesia, run by Tianjin Union Medical Center 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 9 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: status not confirmed, as of the sponsor's last update on 31 Dec 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Yang, Master (18920802290 ext. +86-10, yangtao@nankai.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative propofol Consumption (time frame: intraoperative). 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 31 Dec 2020.