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Effect Of Ketamine Infusion In Patients With COPD Applied One Lung Ventilation

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ClinicalTrials.gov Identifier: NCT02962999
Recruitment Status : Completed
First Posted : November 15, 2016
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Feride Karacaer, Cukurova University

Tracking Information
First Submitted Date  ICMJE October 31, 2016
First Posted Date  ICMJE November 15, 2016
Last Update Posted Date May 30, 2018
Actual Study Start Date  ICMJE January 2017
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
Change of Peak airway pressure (mmHg) [ Time Frame: From the start of OLV to end of OLV intraoperatively (before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV) ]
Peak airway pressure (Ppeak-mmHg) will be recorded before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV. Change from initiation of Ppeak at 120 minute will be evaluated.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
  • Change of arteriel P02 [ Time Frame: From the start of OLV to postoperative 1 hour.(before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV. Pa02 in blood gas values will be recorded 20 minute after arrival at postoperative care unit. ]
    arteriel blood gas value (Pa02-mmHg) will be recorded before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV and postoperative 1 hour. Pa02 in blood gas values will be recorded 20 minute after and 1 hour after arrival at postoperative care unit.
  • Change of Shunt fraction [ Time Frame: From the start of OLV to end of OLV intraoperatively (before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV) ]
    Shunt fraction will be calculated with; Qs/Qt= (5,8xRI)+6,7 RI= Respiratory index RI= (PA02-Pa02)/ Pa02 PA02= Alveolar 02 pressure PA02= ([PB-PH20]x Fi02)- PaC02 PB= Atmosphere pressure= 760 mmHg PH20= Water vapor pressure= 47 mmHg shunt fraction will be recorded before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation OLV
  • Change of Plato airway pressure (mmHg) [ Time Frame: From the start of OLV to end of OLV intraoperatively (before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV) ]
    Plato airway pressure (Pplato-mmHg) will be recorded before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV. Change from initiation of Ppeak at 120 minute will be evaluated.
  • Change of arteriel PC02 [ Time Frame: From the start of OLV to postoperative 1 hour.(before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV. PaC02 in blood gas values will be recorded 20 minute after arrival at postoperative care unit.) ]
    arteriel blood gas value (PaC02-mmHg) will be recorded before initiation of OLV and 30 minutes intervals up to 120 minutes after initiation of OLV and postoperative 1 hour. PaC02 in blood gas values will be recorded 20 minute after and 1 hour after arrival at postoperative care unit.
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 Effect Of Ketamine Infusion In Patients With COPD Applied One Lung Ventilation
Official Title  ICMJE Effect Of Ketamine Infusion On Oxygenation And Ventilation Mechanics In Patients With Chronic Obstructive Pulmonary Disease Applied One Lung Ventilation
Brief Summary Chronic obstructive pulmonary disease (COPD) patients often undergo thoracic surgery due to lung cancer and emphysematous changes. One lung ventilation (OLV) used in thoracic surgery aggravates hypoxia and hypercapnia increasing intrapulmonary shunt and dead space.Ketamine provide bronchodilation by inhibiting the reuptake of catecholamines in the circulation. It also serves relaxation of bronchial smooth muscle. Our aim in this study, effects of ketamine on arterial oxygenation, the shunt fraction and the lung mechanics in patients with COPD who administered OLV because of thoracic surgery. Thirty patients with COPD who undergo thoracotomy for lung lobectomy will be included in this study. Patients will be randomly divided to a control group (%0,9 saline- CG) or a keta (ketamine- KG) group. KG will be administered 1 mg/kg ketamine bolus, then 0,5 mg/kg/hour ketamine infusion after the induction, CG will be administered sline bolus, then saline infusion. Peak airway pressure (Ppeak), plato airway pressure (Pplato), static compliance, shunt fraction, PaO2/FiO2 and arteriel blood gas values (Pa02, PaC02) will be recorded before initiation of OLV and 30 minutes intervals after initiation of OLV.To evaluate the postoperative pulmonary complications, Pa02, PaC02 in blood gas and Pa02/Fi02 values will be recorded 20 minute after arrival at postoperative care unit. Patients will be evaluated for pneumonia, atelectasis and acute lung injury at postoperative 72 h and findings will be recorded. 30 day mortality will be recorded.
Detailed Description Chronic obstructive pulmonary disease (COPD) is a risk factor for cardiopulmonary morbidity and mortality after thoracic surgery. The elastic recoil reduction and structural changes in the small airways and alveoli cause pulmonary air trapping and hyperinflation in patients with COPD. Chronic alveolar hypoxia results structural changes in the pulmonary arteriol such as medial hypertrophy and muscularization. Ventilation-perfusion mismatch and from the right to left shunt cause hypoxia in patients with COPD. COPD patients often undergo thoracic surgery due to lung cancer and emphysematous changes. One lung ventilation (OLV) used in thoracic surgery aggravates hypoxia and hypercapnia increasing intrpulmonary shunt and dead space. Positive end expirium pressure (PEEP) and alveolary recruitment are not applicable to treat hypoxia because of development of high intrinsic PEEP. Ketamine is an intravenous general anesthetic agent widely used for many years and has sympathomimetic bronchodilator features on the airway. Ketamine provide bronchodilation by inhibiting the reuptake of catecholamines in the circulation. It also serves relaxation of bronchial smooth muscle. Our aim in this study, effects of ketamine on arterial oxygenation, the shunt fraction and the lung mechanics in patients with COPD who administered OLV because of thoracic surgery. This prospective, randomized, double blinded, controlled study will be conducted following Cukurova University Faculty of Medicine Ethics Committee approval and written informed patient consent. Thirty patients who undergo thoracotomy for lung lobectomy will be included in this study.Patients will be monitored for electrocardiography (ECG), oxygen saturation (Sa02) and non-invasive blood pressure and applied thoracal (T 5-8) epidural catheter which will be used postoperative analgesia. After the induction of anesthesia, patients will be intubated with double lumen tube (DLT). The position of the DLT will be confirmed with fiberoptic bronchoscope. Anesthesia will be maintained with %4-6 desflurane and 0,25-0,5 microgram/dk/min remifentanil. Desflurane will be titrated to maintain a bispectral index of 40 to 60.Patients will be randomly divided to a control group (%0,9 saline- CG) or a keta (ketamine- KG) group. KG will be received 1 mg/kg ketamine bolus, then 0,5 mg/kg/hour ketamine infusion will be administered until the end of operation, CG will be received bolus saline, then saline infusion will be administered until the end of operation . Patients will be ventilated with volume controlled ventilation (VCV), tidal volume (TV) 8 mlt/kg and rate of inspirium:expirium (I:E)=1:2,5 during two lung ventilation. During OLV, the lungs were ventilated with VCV, TV 5 mlt/kg, I:E=1:2,5, PEEP= 5cmH20. The fraction of inspired oxygen (Fi02) will initially set at 0,6. In cases of desaturation to Sa02 less than 95%, Fi02 will be increased by 0,2 up to 1,0. Peak airway pressure (Ppeak), plato airway pressure (Pplato), static compliance, shunt fraction and arteriel blood gas values (Pa02, PaC02) will be recorded before initiation of OLV and 30 minutes intervals after initiation of OLV. To evaluate the postoperative pulmonary complications, Pa02, PaC02 in blood gas and Pa02/Fi02 values will be recorded 20 minute after and 1 hour after arrival at postoperative care unit. If the patient shows signs of dyspnea and Pa02/Fi02<300, the patient will be admitted intensive care unit. Patients will be evaluated for pneumonia, atelectasis and acute lung injury at postoperative 72 h and findings will be recorded. 30 day mortality will be recorded.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Condition  ICMJE
  • Chronic Obstructive Pulmonary Disease Mild
  • Chronic Obstructive Pulmonary Disease Moderate
  • Chronic Obstructive Pulmonary Disease Severe
  • Lungcancer
  • Anesthesia
Intervention  ICMJE
  • Drug: Ketamine
    After induction, patients will be received 1 mg/kg ketamine bolus, then administered 0,5 mg/kg/hour ketamine infusion intraoperatively.
    Other Name: Ketalar
  • Drug: Saline
    After induction, patients will be received saline bolus, then will be administered saline infusion intraoperatively.
    Other Name: %0,9 NaCl
Study Arms  ICMJE
  • Experimental: Ketamine
    After induction, patients will be received 1 mg/kg ketamine bolus, then will be administered 0,5 mg/kg/hour ketamine infusion intraoperatively. Anesthesia will be maintained with %4-6 desflurane and 0,25-0,5 microgram/dk/min remifentanil.
    Intervention: Drug: Ketamine
  • Placebo Comparator: Saline
    After induction, patients will be received saline bolus, then will be administered saline infusion intraoperatively. Anesthesia will be maintained with %4-6 desflurane and 0,25-0,5 microgram/dk/min remifentanil.
    Intervention: Drug: Saline
Publications *

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2018)
30
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2016)
50
Actual Study Completion Date  ICMJE March 2018
Actual Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age more than 40 years
  • American Society of Anesthesiologists' physical status 2-3
  • Diagnosis of COPD
  • Forced expiratory volume in 1 second (FEV1) ≥ %50 in a preoperative pulmonary function test.

Exclusion Criteria:

  • Heart failure
  • Severe functional liver or kidney disease
  • Pregnancy,
  • Obesity (BMI≥30)
  • Respiratory failure (Pa02< 55 mmHg, PaC02> 55 mmHg)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02962999
Other Study ID Numbers  ICMJE KCOPD1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Feride Karacaer, Cukurova University
Study Sponsor  ICMJE Cukurova University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Feride Karacaer, Specialist Çukurova University
PRS Account Cukurova University
Verification Date May 2018

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