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.: PACTR202001501945752 Date of Approval: 28/01/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Endoscopy mask for sevoflurane sedation during upper GIT endoscopy, prospective randomized study
Official scientific title Endoscopy mask for sevoflurane sedation during upper GIT endoscopy, prospective randomized study
Brief summary describing the background and objectives of the trial Introduction Upper endoscopic procedures are a common noninvasive procedure indicated for both diagnostic and therapeutic indications[1]. The use of moderate and deep sedation allows for a more thorough and relaxed procedure. Medications like propofol, benzodiazepines, opioids is used foe sedation during the procedure, however complications like airway obstruction, hypoventilation, hypoxia has been reported[2–4]. Sevoflurane is an inhaled anesthetic agent with pleasant odor allowing mask induction, rapid onset and rapid emergence from anesthesia, and minimal airway irritation, respiratory depression and hemodynamic effects. These advantages make sevoflurane a suitable choice for sedation in many patients, either alone or in conjunction with other agents. Wang CY et al[5] reported that sevoflurane could be used for upper gastrointestinal endoscopy. Endoscopy mask is modified face mask with extra-orifice that is originally used for upper endoscopy probe advancement while patient ventilation is maintained using CPAP or BIPAP modes. The extra-orifice has been applied as a method to maintain ventilation during fiberoptic bronchoscopy (FOB) intubation attempts [6–9]. The extra-orifice can be used to deliver sevoflurane as maintenance agent in the expected difficult or lengthy endoscopic procedures giving the advantage of maintaining the airway patency, effective ventilation and oxygenation and enough time for the endoscopist. In this study, sevoflurane sedation through the endoscopy mask will be compared to the intravenous sedation during upper GIT endoscopy. The primary outcome was difference in the incidence of hypoxia (defined Spo2 less than 94). Secondary outcome variables will include incidence of bronchospasm, gagging, emergence time and operator satisfaction.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Digestive System,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 20/01/2020
Actual trial start date 01/02/2020
Anticipated date of last follow up 20/03/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Mask group propofol (1-2 mg/kg intravenous ) at the start of the endoscopy then anesthesia is maintained maintained with sevoflurane 2% in 100% oxygen via the endoscopy mask Anesthesia will be induced using propofol (1-2 mg/kg) and maintained with sevoflurane 2% in 100% oxygen via the endoscopy mask sedation for upper endoscopy will be induced by intravenoous propofol (1-2 mg/kg) at the start of the endoscopy then anesthesia is maintained maintained with sevoflurane 2% in 100% oxygen via the endoscopy mask 35
Control Group Control group Anesthesia will be induced and maintained using propofol (1-2 mg/kg) at the start of the procedure then maintained by IV boluses of 0.5 mg/kg when required. during the upper endoscopy procedure. sedation for upper endoscopy procedure will be induced and maintained using propofol (1-2 mg/kg) at the start of the procedure then maintained by IV boluses of 0.5 mg/kg when required. 35 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients scheduled upper endoscopy procedures, with age between 20 to 45 years. Exclusion criteria will include; significant lung disease, previous history of difficult intubation, moderate to severe obstructive sleep apnea and airway pathology. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 45 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 08/01/2020 Institutional research board
Ethics Committee Address
Street address City Postal code Country
Elgomhoreya Mansoura 22555 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the incidence of hypoxia (defined Spo2 less than 94) during the upper endoscopy proceudre
Secondary Outcome emergence time time required for emergence from anesthesia in minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Elgomhoreya Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alrefaey Alrefaey Elobour street Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university Elgomhoreya Mansoura Egypt University
COLLABORATORS
Name Street address City Postal code Country
Emad elhefnawey Geihan street Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elobour
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Public Enquiries Alrefaey Alreafey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Alrefaey Alrefaey refa3ey2@yahoo.com +201064203475 Elgomhoreya
City Postal code Country Position/Affiliation
Mansoura Egypt Mansoura university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Study protocol -Results tables Clinical Study Report,Study Protocol one yer after study data will be available upon request from researchers approved by an independent ethical committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information