- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02962999
Effect Of Ketamine Infusion In Patients With COPD Applied One Lung Ventilation
May 26, 2018 updated by: Feride Karacaer, Cukurova University
Effect Of Ketamine Infusion On Oxygenation And Ventilation Mechanics In Patients With Chronic Obstructive Pulmonary Disease Applied One Lung Ventilation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
30
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Adana, Turkey, 01330
- Çukurova university
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Adana, Turkey
- Cukurova University Faculty of Medicine Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
38 years to 78 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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.
|
After induction, patients will be received 1 mg/kg ketamine bolus, then administered 0,5 mg/kg/hour ketamine infusion intraoperatively.
Other Names:
|
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.
|
After induction, patients will be received saline bolus, then will be administered saline infusion intraoperatively.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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.
|
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
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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)
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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.
|
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)
|
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.
|
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.)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Feride Karacaer, Specialist, Çukurova university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Weinreich AI, Silvay G, Lumb PD. Continuous ketamine infusion for one-lung anaesthesia. Can Anaesth Soc J. 1980 Sep;27(5):485-90. doi: 10.1007/BF03007049.
- Rees DI, Gaines GY 3rd. One-lung anesthesia--a comparison of pulmonary gas exchange during anesthesia with ketamine or enflurane. Anesth Analg. 1984 May;63(5):521-5.
- Lee SH, Kim N, Lee CY, Ban MG, Oh YJ. Effects of dexmedetomidine on oxygenation and lung mechanics in patients with moderate chronic obstructive pulmonary disease undergoing lung cancer surgery: A randomised double-blinded trial. Eur J Anaesthesiol. 2016 Apr;33(4):275-82. doi: 10.1097/EJA.0000000000000405.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
March 1, 2018
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
October 31, 2016
First Submitted That Met QC Criteria
November 9, 2016
First Posted (Estimate)
November 15, 2016
Study Record Updates
Last Update Posted (Actual)
May 30, 2018
Last Update Submitted That Met QC Criteria
May 26, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Lung Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- KCOPD1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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