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.: PACTR201706002232945 Date of Approval: 23/04/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sedative regimens for drug induced sleep endoscopy in sleep apnea patients.
Official scientific title Respiratory and hemodynamic effects of three different sedative regimens for drug induced sleep endoscopy in sleep apnea patients. A prospective randomized study
Brief summary describing the background and objectives of the trial Obstructive Sleep Apnea (OSA) is a syndrome characterized by the episodes of apnea or hypopnea due to obstruction in the upper air¬ways.Continuous positive airway pressure is considered to be the most efficacious conservative treatment but up to 40 % of patients are non-compliant during long-term follow- up and need surgical treatment.Drug-Induced Sleep Endoscopy (DISE) is a method with which somnolence is induced pharmacologically and obstruction in the upper airways is evaluated through nasal endoscopy in patients with OSA. DISE provides a dynamic, three-dimensional, real-time evaluation of the upper airway collapse during sedative-induced sleep.An ideal anesthetic regimen during DISE requires that the patient is in a state mimicking physiological sleep as closely as possible, while breathing spontaneously via the native airway, with oxygen desaturation levels that mimic those seen during natural sleep.The ideal drug for DISE should have a short half life and be available for IV and infusion with minimal impact on respiratory drive, muscle tone and rapid eye movement (REM) sleep.Propofol is an ideal agent because it is a hypnotic drug with a very short half life.Combination of Ketamine and Propofol provides sedation, analgesia and rapid recovery with hemodynamic stability and minimal respiratory depression.Dexmedetomidine is an ¿2 adrenergic agonist, with sedative, anxiolytic, and analgesic effects. The aim of this study is to compare between propofol, dexmedetomidine and ketofol when used for sedation during drug induced sleep endoscopy in sleep apnea patients as regards respiratory and hemodynamic variables, time to achieve sufficient sedation level and surgeon's satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DISE OSA
Disease(s) or condition(s) being studied Drug-Induced Sleep Endoscopy, Obstructive Sleep Apnea
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 08/05/2017
Actual trial start date
Anticipated date of last follow up 06/11/2017
Actual Last follow-up date
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
Research Ethics Commitee, Tanta University, Facualty of Medicine Approval code: 31426/03/17
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Patients will be randomly assigned to receive one of three different sedative drugs for DISE by 1:1:1 ratio. The propofol group (Group P n=20), the dexmedetomidine group (Group Dex n=20) and the ketofol group (Group K n=20). The randomization will be done by sealed envelopes indicating the group of the assignment. A blinded nurse, who does not participate in the study or data collection, will read the number contained in the envelope and make group assignments. sealed opaque envelopes Masking/blinding used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Patients will be randomly assigned to receive one of three different sedative drugs for DISE by 1:1:1 ratio. The propofol group (Group P n=20), the dexmedetomidine group (Group Dex n=20) and the ketofol group (Group K n=20). The randomization will be done by sealed envelopes indicating the group of the assignment. A blinded nurse, who does not participate in the study or data collection, will read the number contained in the envelope and make group assignments. sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group propofol loading dose of 0.7 mg/kg for 10 minutes followed by the mainte¬nance dose of 0.5 mg/kg/h bolus and infusion The propofol syringe contains 20 ml propofol 1% plus 30 ml normal saline to provide a concentration 4mg/ml 20 Active-Treatment of Control Group
Experimental Group dexmedetomidine loading dose of 1 mcg/kg for 10 minutes followed by the mainte¬nance dose of 0.3 mcg/kg/h. bolus and infusion dexmedetomidine syringe contains 2 ml dexmedetomidine 200mcg added to 48 ml normal saline to provide a concentration 4mcg/ml 20
Experimental Group ketofol ketofol mixture will be administered with a loading dose of 1 mg/kg over 10 minutes followed by the mainte¬nance dose of 50 mcg/kg/h bolus and infusion mixture in a ratio 1:1 is prepared by adding 10 ml propofol 1% to 2 ml ketamine (ketamine one ml =50 mg) plus 38 ml normal saline to provide a concentration 2mg/ml propofol and 2mg/ml ketamine 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
both sexes aged between 18-50 years old classified as American Society of Anesthesiologists ASA physical status I, II, III, diagnosed as OSAS by clinical criteria(snoring , morning headache, day sleepiness and tiredness) and polysomnography (apnea hypopnea index>5) 1- Patients who refuse to give informed consent 2- Patients with a baseline oxygen desaturation (resting hypoxemia <95 %) 3- Patients with Mallampati scores of III-IV 4- Patients who are pregnant 5- Patients with frank aspiration history 6- Drug abusers or those having history of chronic anal¬gesic use 7- Patients who known to have allergy against the study drugs, 8- Patients with IInd-IIIrd degree A-V block, pulmonary hypertension ,uncontrolled systemic hypertension, mitral stenosis, aortic stenosis or ischemic heart diseases will be excluded 9- Patients with psychiatric dis¬orders will be also excluded from the study. 18 Year(s) 50 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 29/03/2017 Research Ethics committee, Facualty of medicine, Tanta University
Ethics Committee Address
Street address City Postal code Country
El-geish st Tanta/gharbia 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome measurement of the incidence of oxygen desaturation among the three groups. Oxygen desaturation is defined as oxygen saturation <90% for more than 30 s, measured using pulse oximetry(9). Continuous through pulse oximetry
Secondary Outcome ¿ cough reflex (cough and/or sneezing) incidence Continuous through pulse oximetry
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Facualty of medicine,Tanta university hospitals El-Geish st Tanta/Gharbia 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The researchers support this work Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rehab Said ElKalla El-Geish st Tanta/Gharbia 31257 Egypt University
Secondary Sponsor Mona Blough El Mourad El-Geish st Tanta/Gharbia 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Rehab Said ElKalla El-Geish st Tanta/Gharbia 31257 Egypt
Mona Blough El Mourad El-Geish st Tanta/Gharbia 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rehab ElKalla rehouba10@hotmail.com +201285700765 Elgeish st
City Postal code Country Position/Affiliation
Tanta/Gharbia 31257 Egypt Lecturer of anesthesiology and surgical ICU Faculty of medicine-Tanta University
Role Name Email Phone Street address
Public Enquiries Rehab ElKalla rehouba10@hotmail.com +201285700765 Elgeish st
City Postal code Country Position/Affiliation
Tanta/Gharbia 31257 Egypt Lecturer of anesthesiology and surgical ICU Faculty of medicine-Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mona Blough El Mourad monamorad80@gmail.com +201225124747 Elgeish st
City Postal code Country Position/Affiliation
Tanta/Gharbia 31257 Egypt Lecturer of anesthesiology and surgical ICU Faculty of medicine-Tanta University
REPORTING
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