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

NCT02962999 | Completed Phase 4

• 1 other identifier: KCOPD1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease Mild; Chronic Obstructive Pulmonary Disease Moderate; Chronic Obstructive Pulmonary Disease Severe; Lungcancer; Anesthesia

Keywords

Ketamine; One lung ventilation; Chronic obstructive pulmonary disease

Outcome Measures

Primary Outcomes (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.

  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)

• Change of arteriel P02

  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

  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 Plato airway pressure (mmHg)

  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

  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.)

Study Arms (2)

Ketamine

EXPERIMENTAL

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

Saline

PLACEBO COMPARATOR

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

Interventions

Ketamine DRUG

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

Also known as: Ketalar

Ketamine

Saline DRUG

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

Also known as: %0,9 NaCl

Saline

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (2)

Cukurova University

Adana, 01330, Turkey (Türkiye)

Location

Cukurova University Faculty of Medicine Research Hospital

Adana, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 7448609 BACKGROUND

• 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.

  PMID: 6711845 BACKGROUND

• 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.

  PMID: 26716866 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Feride Karacaer, Specialist

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist doctor

Study Record Dates

• First Submitted: October 31, 2016
• First Posted: November 15, 2016
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 30, 2018

Record last verified: 2018-05

Locations

TU (2)