Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201708002458366 Date of Approval: 22/07/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of inhaled corticosteroid and Beta agonist on oxygenation parameters and inflammatory markers during lung surgery.
Official scientific title Effect of inhaled corticosteroid and Beta agonist on oxygenation parameters and inflammatory markers during lung surgery.
Brief summary describing the background and objectives of the trial One lung ventilation (OLV) during lung surgery might induce alveolar cell insult and release of inflammatory mediators that may have great impact on postoperative pulmonary complications and outcome. The current study was aimed to evaluate effect of inhaled corticosteroid and Beta agonist on oxygenation parameters and inflammatory markers during lung surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied lung surgery,Respiratory,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 31/07/2017
Actual trial start date 31/07/2017
Anticipated date of last follow up 30/07/2018
Actual Last follow-up date 30/07/2018
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group treatment group receiving combined standard aerosolized doses of budesonide (0.5 mg/2 mL) and formoterol (20 ¿g/2 mL) given in 3 doses before surgery; the first dose will be given at 4 h and 2nd dose at 2 h before su receiving combined standard aerosolized doses of budesonide (0.5 mg/2 mL) and formoterol (20 ¿g/2 mL) given in 3 doses before surgery; the first dose will be given at 4 h and 2nd dose at 2 h before surgery whereas the 3rd dose will be given immediately before induction of anesthesia. 30
Control Group Placebo 4 mL normal saline given in 3 doses before surgery; the first dose will be given at 4 h and 2nd dose at 2 h before surgery whereas the 3rd dose will be given immediately before induction of anesthesia Placebo group receiving 4 mL normal saline given in 3 doses before surgery; the first dose will be given at 4 h and 2nd dose at 2 h before surgery whereas the 3rd dose will be given immediately before induction of anesthesia. 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult patients undergoing open lung surgery patient refusal to enroll, uncompensated heart problem or mean pulmonary artery pressure (MPAP) > 30 mm Hg, severe lung problem [vital capacity (VC) or forced expiratory volume in 1 s (FEV1) < 50% of the predicted values], renal or hepatic insufficiency, coagulopathy or preoperative immuno-suppressant drugs administration. Intraoperative exclusion criteria included failure to keep a satisfactory arterial oxygen saturation(SaO2) and or end-tidal carbon dioxide (EtCO2), failure to preserve appropriate ventilation parameters for 20 min, and inability to keep hemodynamic stability . 18 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2017 Ethical committee of Minoufiya Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
2Yaseen Abdel-Ghaffar st. Shebin Elkoam 32511 Egypt Shebin Elkoam 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome arterial oxygen tension/fraction of inspired oxygen (PaO2/FIO2) ratio 30 min after total lung ventilation (TLV) (T0), 30 min after OLV (T1), 30 min after return to TLV (T2) and at end of surgery (T3
Secondary Outcome arterial, and central venous blood gases, changes in alveolar and plasma levels of tumor necrosis factor-¿, and interleukin-8 in addition to changes in alveolar cell numbers and albumin concentrations , obtained at four different time points: 30 min after total lung ventilation (TLV) (T0), 30 min after OLV (T1), 30 min after return to TLV (T2) and at end of surgery (T3).
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Minoufiya University hospital 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Minoufiya University 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amany S Ammar 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
Khaled M Mahmoud 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
Zeinab Abdel-Aziz Kasemy 2 Yaseen Abdel-Ghaffar st., Shebin Elkoam, 32511 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.,
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Public Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
Role Name Email Phone Street address
Scientific Enquiries khaled mahmoud mahmoudk16@yahoo.com +201224884620 2 Yaseen Abdel-Ghaffar st.
City Postal code Country Position/Affiliation
Shebin Elkoam 32511 Egypt Professor in anesthesiology, Minoufiya faculty of medicine
REPORTING
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