AtelectasisEarly Phase 1NCT04745286
Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Anesthetized Patients Accessed by Pulmonary Ultrasound
A Early Phase 1 study testing S-ketamine and normal saline group in people with Atelectasis, run by Beijing Tiantan Hospital.
Trial summary
Background: Atelectasis occurs in the majority of patients with general anesthesia, which can lead to postoperative pulmonary complications (PPCs) and affect the postoperative outcome. However, there is still no exact method to prevent it though agents. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Atelectasis
- What is being tested?
- S-ketamine and normal saline group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Mar 2022
- Phase
- Early Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age of 18 - 60 years;
- American Society of Anesthesiologists (ASA) physical status of I - II;
- Patients scheduled for urinary, obstetrics and gynecology surgery in supine position or lithotomy position under general anesthesia, and the expected operation time is more than 1 hour;
- Patients and their authorized surrogates have signed the informed consent form.
Who cannot join
- Patients who have difficulty in applying pulmonary ultrasound, such as chest fractures, surgical history, etc;
- Patients who have a history of upper respiratory tract infection one month before surgery, or a history of smoking more than 6 packs/year;
- Preoperative chest X-ray or CT abnormalities, including atelectasis, pneumothorax, pleural effusion or pneumonia;
- BMI>30kg/㎡;
- Expected difficulty in intubation or mask ventilation;
- Patients with significant increase in intraocular pressure and intracranial pressure before surgery;
- Patients allergic to S-ketamine, propofol and opioids.
- Patients with a positive history of psychiatric disorders.
About this study
Official title: Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Patients Undergoing General Anesthesia Accessed by Pulmonary Ultrasound：Study Protocol for a Randomized, Double-blinded Controlled Trial
Background: Atelectasis occurs in the majority of patients with general anesthesia, which can lead to postoperative pulmonary complications (PPCs) and affect the postoperative outcome. However, there is still no exact method to prevent it though agents. S-ketamine may prevent atelectasis due to its airway smooth muscle relaxation and anti-inflammatory effects. Lung ultrasound is a portable and reliable bedside imaging technology for diagnosing anesthesia-induced atelectasis. Here, we intend to assess whether small-dose of S-ketamine can reduce the incidence of atelectasis after intubation under general anesthesia using lung ultrasound, in order to prevent the early formation of perioperative atelectasis and perioperative pulmonary complications.
Methods: The trial is a single institution, prospective, randomized controlled, parallel grouping, double-blind study. From October 2021 to March 2022, 100 patients (18-60 years old) scheduled for elective surgery will be recruited from Beijing Tiantan Hospital, Capital Medical University, and randomly assigned to the S-ketamine group (Group S) and the normal saline group (Group N) at a ratio of 1:1. The label-masked agents will be given 5 minutes before induction and all patients will undergo a standardized general anesthesia protocol. Related data will be collected at three time point: after radial artery puncture (T1), 15 minutes after tracheal intubation (T2) and before extubation (T3). The primary outcome will be the total LUS scores at T2. Secondary outcomes include LUS scores in 6 chest regions at T2; total LUS scores at T3; arterial blood-gas analysis results (PaCO2, PaO2) and PaO2/FiO2 at T2 and T3, plateau pressure(Pplat) and dynamic lung compliance (Cdyn) at T2 and T3; the incidence of postoperative complications associated with S-ketamine and postoperative pulmonary complications (PPCs) 2 and 24 hours after surgery；.
Read more
Discussion: This trial aims to explore whether a simple and feasible application of S-ketamine before the induction of general anesthesia can prevent atelectasis. The results of this study may provide new ideas and direct clinical evidence for the prevention and treatment of perioperative pulmonary complications during anesthesia.
Key words: atelectasis, S-ketamine, ultrasound, RCT, protocol
- Conditions
- Atelectasis
- Being tested
- S-ketamine, normal saline group
- Keywords
- atelectasis, S-ketamine, ultrasound, RCT, protocol
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamineDrug
Patients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Agent preparation method of S-ketamine group (Group S): Draw the dosage of S-ketamine 0.25mg ·kg -1 and dilute it with normal saline to 5ml in opaque 5-ml syringes.
normal saline groupDrug
Patients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Normal saline group (Group N): 5ml of normal saline, labeled as "study agents".
| Study group | Role | What they receive |
|---|---|---|
| S-ketamine group | Experimental | Not described Receives: Drug: S-ketamine |
| saline group | Placebo comparator | Not described Receives: Drug: normal saline group |
What is being measured
The primary outcome is the main question the study is designed to answer.
total lung sonography scores(LUS) scores at T2
Using SonoSite M-Turbo with a 5-12 MHz linear transducer,patients will be scanned and scored in the supine position following the lung ultrasound method described by Sun L and colleagues. Briefly, six regions will be scanned on in each hemithorax. Scans 1 and 2 will be performed at the midline of the clavicle, scans 3 and 4 will be performed in the axilla midline. The intercostal scans (Scans 5-6) will be performed in the fifth and sixth intercostal spaces of the posterior axillary line. Place a linear probe parallel to the ribs and scan the intercostal space of each region using a two-dimensional view sequentially from right to left, cranial to caudal, and anterior to posterior within 2 minutes.Each region will be categorised and assigned into four scores(0-3) based on B-lines.Add the scores in all twelve regions to get total lung sonography scores(LUS). Finally get a score between 0 (no atelectasis) and 36 (complete atelectasis).
Measured: T2：at the time of tracheal intubation
Secondary outcomes (6)
LUS scores in 6 chest regions(scans 1-6) at T2
Using SonoSite M-Turbo with a 5-12 MHz linear transducer,patients will be scanned and scored in the supine position following the lung ultrasound method described by Sun L and colleagues. Briefly, six regions will be scanned on in each hemithorax. Scans 1 and 2 will be performed at the midline of the clavicle, scans 3 and 4 will be performed in the axilla midline. The intercostal scans (Scans 5-6) will be performed in the fifth and sixth intercostal spaces of the posterior axillary line. Place a linear probe parallel to the ribs and scan the intercostal space of each region using a two-dimensional view sequentially from right to left, cranial to caudal, and anterior to posterior within 2 minutes.Each region will be categorised and assigned into four scores(0-3) based on B-lines. Finally get six sets of data betweem 0(no atelectasis) and 6 (complete atelectasis).
Measured: T2：at the time of tracheal intubation
total LUS scores at T3
Using SonoSite M-Turbo with a 5-12 MHz linear transducer,patients will be scanned and scored in the supine position following the lung ultrasound method described by Sun L and colleagues. Briefly, six regions will be scanned on in each hemithorax. Scans 1 and 2 will be performed at the midline of the clavicle, scans 3 and 4 will be performed in the axilla midline. The intercostal scans (Scans 5-6) will be performed in the fifth and sixth intercostal spaces of the posterior axillary line. Place a linear probe parallel to the ribs and scan the intercostal space of each region using a two-dimensional view sequentially from right to left, cranial to caudal, and anterior to posterior within 2 minutes.Each region will be categorised and assigned into four scores(0-3) based on B-lines. Finally get a score between 0 (no atelectasis) and 36 (complete atelectasis).
Measured: T3：5min before extubation
arterial blood-gas analysis results (PaCO2, PaO2) and PaO2/FiO2 at T2 and T3
arterial blood samples will be obtained through radial artery puncture and blood-gas measurements will be performed immediately using a standard technique (ABL800) to get arterial blood-gas analysis results (PaCO2, PaO2) and PaO2/FiO2 at T2 and T3
Measured: after tracheal intubation (T2) and 5min before extubation (T3)
plateau pressure and dynamic lung compliance (Cdyn) at T2 and T3
[Cdyn = tidal volume/(PIP-PEEP)]
Measured: after tracheal intubation (T2) and 5min before extubation (T3)
the incidence of postoperative complications associated with S-ketamine 2 and 24 hours after surgery
visual impairment, dizziness, pathological irritability, nightmares and hallucinations
Measured: 2 and 24 hours after surgery
the incidence of postoperative pulmonary complications (PPCs)
the clinical outcome defifinitions of PPCs will adopt European joint taskforce guidelines published in 2015 which include respiratory infection; respiratory failure; atelectasis; pleural effusion; pneumothorax; bronchospasm, aspiration pneumonia; pulmonary edema; ARDS; tracheobronchitis; pulmonary oedema; exacerbation of pre-existing lung disease; pulmonary embolism
Measured: 2 and 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 posted9 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtelectasisStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745286
- Sponsor's protocol ID
- 20210106
- Status last verified
- Feb 2021
- First submitted
- 2 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhang D, Liang Y, Bao D, Xiong W, Li L, Wang Y, Liu B, Jin X. Effects of small-dose S-ketamine on anesthesia-induced atelectasis in patients undergoing general anesthesia accessed by lung ultrasound: study protocol for a randomized, double-blinded controlled trial. Trials. 2024 Jan 18;25(1):64. doi: 10.1186/s13063-023-07779-y.
PubMed 38238838
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Patients Undergoing General Anesthesia Accessed by Pulmonary Ultrasound：Study Protocol for a Randomized, Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT04745286
- Acronym / sponsor ID
- 20210106
- Conditions
- Atelectasis
- Keywords
- atelectasis, S-ketamine, ultrasound, RCT, protocol
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 9 Feb 2021 (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.
Background: Atelectasis occurs in the majority of patients with general anesthesia, which can lead to postoperative pulmonary complications (PPCs) and affect the postoperative outcome. However, there is still no exact method to prevent it though agents. S-ketamine may prevent atelectasis due to its airway smooth muscle relaxation and anti-inflammatory effects. Lung ultrasound is a portable and reliable bedside imaging technology for diagnosing anesthesia-induced atelectasis. Here, we intend to assess whether small-dose of S-ketamine can reduce the incidence of atelectasis after intubation under general anesthesia using lung ultrasound, in order to prevent the early formation of perioperative atelectasis and perioperative pulmonary complications.
Methods: The trial is a single institution, prospective, randomized controlled, parallel grouping, double-blind study. From October 2021 to March 2022, 100 patients (18-60 years old) scheduled for elective surgery will be recruited from Beijing Tiantan Hospital, Capital Medical University, and randomly assigned to the S-ketamine group (Group S) and the normal saline group (Group N) at a ratio of 1:1. The label-masked agents will be given 5 minutes before induction and all patients will undergo a standardized general anesthesia protocol. Related data will be collected at three time point: after radial artery puncture (T1), 15 minutes after tracheal intubation (T2) and before extubation (T3). The primary outcome will be the total LUS scores at T2. Secondary outcomes include LUS scores in 6 chest regions at T2; total LUS scores at T3; arterial blood-gas analysis results (PaCO2, PaO2) and PaO2/FiO2 at T2 and T3, plateau pressure(Pplat) and dynamic lung compliance (Cdyn) at T2 and T3; the incidence of postoperative complications associated with S-ketamine and postoperative pulmonary complications (PPCs) 2 and 24 hours after surgery；.
Discussion: This trial aims to explore whether a simple and feasible application of S-ketamine before the induction of general anesthesia can prevent atelectasis. The results of this study may provide new ideas and direct clinical evidence for the prevention and treatment of perioperative pulmonary complications during anesthesia.
Key words: atelectasis, S-ketamine, ultrasound, RCT, protocol
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-ketamine group | Experimental | Drug: S-ketamine |
| saline group | Placebo comparator | Drug: normal saline group |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age of 18 - 60 years;
- American Society of Anesthesiologists (ASA) physical status of I - II;
- Patients scheduled for urinary, obstetrics and gynecology surgery in supine position or lithotomy position under general anesthesia, and the expected operation time is more than 1 hour;
- Patients and their authorized surrogates have signed the informed consent form.
Key exclusion criteria (8 listed)
- Patients who have difficulty in applying pulmonary ultrasound, such as chest fractures, surgical history, etc;
- Patients who have a history of upper respiratory tract infection one month before surgery, or a history of smoking more than 6 packs/year;
- Preoperative chest X-ray or CT abnormalities, including atelectasis, pneumothorax, pleural effusion or pneumonia;
- BMI>30kg/㎡;
- Expected difficulty in intubation or mask ventilation;
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 |
|---|---|---|
| S-ketaminePatients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Agent preparation method of S-ketamine group (Group S): Draw the dosage of S-ketamine 0.25mg ·kg -1 and dilute it with normal saline to 5ml in opaque 5-ml syringes. | Drug | S-ketamine group |
| normal saline groupPatients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Normal saline group (Group N): 5ml of normal saline, labeled as "study agents". | Drug | saline group |
Primary outcome
total lung sonography scores(LUS) scores at T2
Time frame: T2：at the time of tracheal intubation
Using SonoSite M-Turbo with a 5-12 MHz linear transducer,patients will be scanned and scored in the supine position following the lung ultrasound method described by Sun L and colleagues. Briefly, six regions will be scanned on in each hemithorax. Scans 1 and 2 will be performed at the midline of the clavicle, scans 3 and 4 will be performed in the axilla midline. The intercostal scans (Scans 5-6) will be performed in the fifth and sixth intercostal spaces of the posterior axillary line. Place a linear probe parallel to the ribs and scan the intercostal space of each region using a two-dimensional view sequentially from right to left, cranial to caudal, and anterior to posterior within 2 minutes.Each region will be categorised and assigned into four scores(0-3) based on B-lines.Add the scores in all twelve regions to get total lung sonography scores(LUS). Finally get a score between 0 (no atelectasis) and 36 (complete atelectasis).
6 secondary outcomes
LUS scores in 6 chest regions(scans 1-6) at T2
Time frame: T2：at the time of tracheal intubation
total LUS scores at T3
Time frame: T3：5min before extubation
arterial blood-gas analysis results (PaCO2, PaO2) and PaO2/FiO2 at T2 and T3
Time frame: after tracheal intubation (T2) and 5min before extubation (T3)
plateau pressure and dynamic lung compliance (Cdyn) at T2 and T3
Time frame: after tracheal intubation (T2) and 5min before extubation (T3)
the incidence of postoperative complications associated with S-ketamine 2 and 24 hours after surgery
Time frame: 2 and 24 hours after surgery
the incidence of postoperative pulmonary complications (PPCs)
Time frame: 2 and 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 9 Feb 2021.
- Derived from this study: PubMed 38238838Zhang D, Liang Y, Bao D, Xiong W, Li L, Wang Y, Liu B, Jin X. Effects of small-dose S-ketamine on anesthesia-induced atelectasis in patients undergoing general anesthesia accessed by lung ultrasound: study protocol for a randomized, double-blinded controlled trial. Trials. 2024 Jan 18;25(1):64. doi: 10.1186/s13063-023-07779-y.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing S-ketamine and normal saline group in people with Atelectasis, run by Beijing Tiantan Hospital.
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 8 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 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
total lung sonography scores(LUS) scores at T2 (time frame: T2：at the time of tracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04745286, which also lists 1 linked publication.
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 9 Feb 2021.