Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Anesthetized Patients Accessed by Pulmonary Ultrasound
Primary Purpose
Atelectasis
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
S-ketamine
normal saline group
Sponsored by
About this trial
This is an interventional prevention trial for Atelectasis focused on measuring atelectasis, S-ketamine, ultrasound, RCT, protocol
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S-ketamine group
saline group
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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).
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
plateau pressure and dynamic lung compliance (Cdyn) at T2 and T3
[Cdyn = tidal volume/(PIP-PEEP)]
the incidence of postoperative complications associated with S-ketamine 2 and 24 hours after surgery
visual impairment, dizziness, pathological irritability, nightmares and hallucinations
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
Full Information
NCT ID
NCT04745286
First Posted
February 2, 2021
Last Updated
February 7, 2021
Sponsor
Beijing Tiantan Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04745286
Brief Title
Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Anesthetized Patients Accessed by Pulmonary Ultrasound
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Tiantan Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atelectasis
Keywords
atelectasis, S-ketamine, ultrasound, RCT, protocol
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-ketamine group
Arm Type
Experimental
Arm Title
saline group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
S-ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
normal saline group
Intervention Description
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".
Primary Outcome Measure Information:
Title
total lung sonography scores(LUS) scores at T2
Description
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).
Time Frame
T2:at the time of tracheal intubation
Secondary Outcome Measure Information:
Title
LUS scores in 6 chest regions(scans 1-6) at T2
Description
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).
Time Frame
T2:at the time of tracheal intubation
Title
total LUS scores at T3
Description
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).
Time Frame
T3:5min before extubation
Title
arterial blood-gas analysis results (PaCO2, PaO2) and PaO2/FiO2 at T2 and T3
Description
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
Time Frame
after tracheal intubation (T2) and 5min before extubation (T3)
Title
plateau pressure and dynamic lung compliance (Cdyn) at T2 and T3
Description
[Cdyn = tidal volume/(PIP-PEEP)]
Time Frame
after tracheal intubation (T2) and 5min before extubation (T3)
Title
the incidence of postoperative complications associated with S-ketamine 2 and 24 hours after surgery
Description
visual impairment, dizziness, pathological irritability, nightmares and hallucinations
Time Frame
2 and 24 hours after surgery
Title
the incidence of postoperative pulmonary complications (PPCs)
Description
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
Time Frame
2 and 24 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Learn more about this trial
Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Anesthetized Patients Accessed by Pulmonary Ultrasound
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