We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Anesthetized Patients Accessed by Pulmonary Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04745286
Recruitment Status : Not yet recruiting
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Information provided by (Responsible Party):
Beijing Tiantan Hospital

Tracking Information
First Submitted Date  ICMJE February 2, 2021
First Posted Date  ICMJE February 9, 2021
Last Update Posted Date February 9, 2021
Estimated Study Start Date  ICMJE March 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2021)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2021)
  • LUS scores in 6 chest regions(scans 1-6) 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. Finally get six sets of data betweem 0(no atelectasis) and 6 (complete atelectasis).
  • total LUS scores at T3 [ Time Frame: T3:5min before extubation ]
    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 [ Time Frame: after tracheal intubation (T2) and 5min before extubation (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 [ Time Frame: after tracheal intubation (T2) and 5min before extubation (T3) ]
    [Cdyn = tidal volume/(PIP-PEEP)]
  • the incidence of postoperative complications associated with S-ketamine 2 and 24 hours after surgery [ Time Frame: 2 and 24 hours after surgery ]
    visual impairment, dizziness, pathological irritability, nightmares and hallucinations
  • the incidence of postoperative pulmonary complications (PPCs) [ Time Frame: 2 and 24 hours after surgery ]
    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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Small-dose S-ketamine on Anesthesia-induced Atelectasis in Anesthetized Patients Accessed by Pulmonary Ultrasound
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Atelectasis
Intervention  ICMJE
  • Drug: S-ketamine
    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.
  • Drug: normal saline group
    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 Arms  ICMJE
  • Experimental: S-ketamine group
    Intervention: Drug: S-ketamine
  • Placebo Comparator: saline group
    Intervention: Drug: normal saline group
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 7, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age of 18 - 60 years;
  2. American Society of Anesthesiologists (ASA) physical status of I - II;
  3. 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;
  4. Patients and their authorized surrogates have signed the informed consent form.

Exclusion Criteria:

  1. Patients who have difficulty in applying pulmonary ultrasound, such as chest fractures, surgical history, etc;
  2. Patients who have a history of upper respiratory tract infection one month before surgery, or a history of smoking more than 6 packs/year;
  3. Preoperative chest X-ray or CT abnormalities, including atelectasis, pneumothorax, pleural effusion or pneumonia;
  4. BMI>30kg/㎡;
  5. Expected difficulty in intubation or mask ventilation;
  6. Patients with significant increase in intraocular pressure and intracranial pressure before surgery;
  7. Patients allergic to S-ketamine, propofol and opioids.
  8. Patients with a positive history of psychiatric disorders.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04745286
Other Study ID Numbers  ICMJE 20210106
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Beijing Tiantan Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Beijing Tiantan Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Tiantan Hospital
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP