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.: PACTR201801002943374 Date of Approval: 05/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sedation in TEE
Official scientific title Effects of propofol, dexmedetomidine or ketofol on respiratory and hemodynamic profiles in cardiac patients undergoing transesophageal echocardiography .A prospective randomized study
Brief summary describing the background and objectives of the trial TEE is an invasive diagnostic tool, it hinders the comfort of the patient and causes nausea, gag reflex, dyspnoea, and emotional distress . Sedatives, such as midazolam and propofol are commonly used prior to probing to make the procedure more tolerable and comfortable for the patient . However, there is an increased risk of hemodynamic and respiratory depression.The aim of this study is to compare the respiratory and hemodynamic effects of propofol, dexmedetomidine and ketofol when used as sedatives for transesophageal echocardiography procedure in cardiac patients with left to right shunt
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,SEDATION
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/01/2018
Actual trial start date 15/01/2018
Anticipated date of last follow up 02/06/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 75
Actual target sample size (number of participants) 75
Recruitment status Completed
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 randomisation table from a statistics book 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 sedation once once propofol infusion is used for sedation in TEE 25 Active-Treatment of Control Group
Experimental Group Dexmedetomidine sedation once once dexmedetomidine is used for sedation in TEE 25
Experimental Group Ketofol sedation once once ketofol is used for sedation in TEE 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-adult patients of both sexes aged between 18-50 years old -with left to right shunt -ASAI-III 1-Patients who refuse to give informed consent 2- Patients who are unstable to receive any kind of sedation 3- Patients severe cardiovascular disease (complex congenital cardiac disease, severe heart failure, ventricular arrhythmias )or severe pulmonary conditions(chronic obstructive airway disease, sleep apnea)or any other condition that would preclude an outpatient TEE procedure 4- Patients with a body mass index over 30. 5- Patients who are pregnant 6- Patients with bleeding disorders 7- Patients with oropharyngeal, esophageal or gastric conditions that may hinder the introduction of TEE 8- Drug abusers or those having history of chronic anal¬gesic use 9- Patients with hypersensitivity to any of the study drugs, 10- Patients who are unable to communicate (a history of mental illness, psychotropic medication use) 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 25/10/2017 research ethics committee of faculty of Medicine Tanta University
Ethics Committee Address
Street address City Postal code Country
El geish Tanta 31257 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome HEMODYNAMIC PARAMETTERS AND TIME TO REACH SUFFICIENT SEDATION ONCE DURING THE PROCEDURE
Secondary Outcome Incidence of oxygen desaturation <90 % ,Total duration of the procedure ,Total duration of recovery from sedation (defined as RSS 2) ,Surgeon's satisfaction using satisfaction score (4=excellent, 3=good, 2=fair, 1=bad) ONCE DURING THE PROCEDURE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university hospital El geish Tanta 31257 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Tanta University El geish Tanta 31257 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta University El geish Tanta 31257 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mona Blough El Mourad El geish Tanta 31257 Egypt
Mohamed Elsayed Afandy El geish Tanta 31257 Egypt
Aliaa Shabaan El geish Tanta 31257 Egypt
dr Sara Ibrahim Elsharkawy El geish street Tanta Elgharbeya 31257 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mona El Mourad monamorad80@gmail.com 0403332033 El geish
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Lecturer of anesthesia and surgical ICU Faculty of medicine-Tanta University
Role Name Email Phone Street address
Public Enquiries Mona El Mourad monamorad80@gmail.com 0403332033 El geish
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Lecturer of anesthesia and surgical ICU Faculty of medicine-Tanta University
Role Name Email Phone Street address
Scientific Enquiries Mohamed Afandy mohamedafandy811@yahoo.com 0403332033 El geish
City Postal code Country Position/Affiliation
Tanta 31257 Egypt Lecturer of anesthesia and surgical ICU Faculty of medicine-Tanta University
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information