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Chronic Obstructive Pulmonary Disease MildPhase 4NCT02962999

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

A Phase 4 study testing Ketamine and Saline in people with Chronic Obstructive Pulmonary Disease Mild and Chronic Obstructive Pulmonary Disease Moderate, run by Cukurova University at 2 sites in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 yearsHealthy volunteers can take part
What is being tested?
Ketamine and Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
2 sitesTurkey (Türkiye)
Study dates
Jan 2017to Mar 2018
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • Heart failure
  • Severe functional liver or kidney disease
  • Pregnancy,
  • Obesity (BMI≥30)
  • Respiratory failure (Pa02< 55 mmHg, PaC02> 55 mmHg)

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Cukurova University

    Adana, 01330

  • Cukurova University Faculty of Medicine Research Hospital

    Adana

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Ketamine, Saline
Keywords
Ketamine, One lung ventilation, Chronic obstructive pulmonary disease
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetamineDrug

    Also called Ketalar

    After induction, patients will be received 1 mg/kg ketamine bolus, then administered 0,5 mg/kg/hour ketamine infusion intraoperatively.

  • SalineDrug

    Also called %0,9 NaCl

    After induction, patients will be received saline bolus, then will be administered saline infusion intraoperatively.

Study groups in NCT02962999
Study groupRoleWhat they receive
KetamineExperimentalAfter 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.
Receives: Drug: Ketamine
SalinePlacebo comparatorAfter 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.
Receives: Drug: Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Peak airway pressure (mmHg)

    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.

    Measured: 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 outcomes (4)
  1. Change of arteriel P02

    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.

    Measured: 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.

  2. Change of Shunt fraction

    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

    Measured: 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)

  3. Change of Plato airway pressure (mmHg)

    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.

    Measured: 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)

  4. Change of arteriel PC02

    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.

    Measured: 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.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionMar 2018
  4. Study completionMar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02962999
Sponsor's protocol ID
KCOPD1
Status last verified
May 2018
First submitted
31 Oct 2016
Last updated
30 May 2018
Results posted
No
Data monitoring committee
No

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.

    PubMed 7448609
  • 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.

    PubMed 6711845
  • 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.

    PubMed 26716866

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketamine and Saline in people with Chronic Obstructive Pulmonary Disease Mild and Chronic Obstructive Pulmonary Disease Moderate, run by Cukurova University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02962999, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2018.

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