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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

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Mild Chronic Obstructive Pulmonary Disease Moderate Chronic Obstructive Pulmonary Disease Severe Lungcancer Anesthesia Drug: Ketamine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Effect Of Ketamine Infusion On Oxygenation And Ventilation Mechanics In Patients With Chronic Obstructive Pulmonary Disease Applied One Lung Ventilation
Actual Study Start Date : January 2017
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD
Drug Information available for: Ketamine

Arm Intervention/treatment
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.
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

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.
Drug: Saline
After induction, patients will be received saline bolus, then will be administered saline infusion intraoperatively.
Other Name: %0,9 NaCl




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962999


Locations
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Turkey
Cukurova University
Adana, Turkey, 01330
Cukurova University Faculty of Medicine Research Hospital
Adana, Turkey
Sponsors and Collaborators
Cukurova University
Investigators
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Study Director: Feride Karacaer, Specialist Çukurova University

Publications:
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Responsible Party: Feride Karacaer, Specialist doctor, Cukurova University
ClinicalTrials.gov Identifier: NCT02962999     History of Changes
Other Study ID Numbers: KCOPD1
First Posted: November 15, 2016    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Keywords provided by Feride Karacaer, Cukurova University:
Ketamine
One lung ventilation
Chronic obstructive pulmonary disease
Additional relevant MeSH terms:
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Lung Neoplasms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action