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.: PACTR201708002325400 Date of Approval: 26/05/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparing the proportion of hypoxia in sedated adults undergoing OGD using TCI propofol versus intermittent boluses
Official scientific title A randomized controlled trial comparing the proportion of hypoxia in sedated adults undergoing upper gastrointestinal endoscopy using target controlled infusion of propofol versus intermittent boluses.
Brief summary describing the background and objectives of the trial Background: A wide variety of sedation techniques are employed to facilitate various invasive diagnostic and therapeutic procedures. Increasingly, propofol is emerging as the preferred sedative agent. Traditionally, it has been administered as intermittent boluses to achieve deep sedation to facilitate gastrointestinal endoscopy. Propofol target controlled infusion can be employed to provide suitably conducive conditions for this purpose. At present, there is a paucity of data comparing the effect of these two modalities of propofol sedation on adult patients undergoing upper gastrointestinal endoscopy. Primary objective ¿To compare the proportion of hypoxia between adults receiving intermittent boluses of propofol(control) versus target controlled infusion of propofol(intervention) for sedation during upper gastrointestinal endoscopy. Secondary objectives ¿To compare the proportion of hypotension and bradycardia between the two study arms. ¿To compare the time to recovery between the two groups. A single-center, randomized controlled trial to be conducted at The Aga Khan University Hospital, Nairobi involving 176 (88 subjects per arm). ASA I and II patients aged 18 to 65 years undergoing non-emergent upper gastrointestinal endoscopy under sedation will be included. A total of 176 patients randomly assigned to one of two groups corresponding to the mode of propofol sedation to be administered (a) Initial bolus propofol 1mg/kg, followed by repeat boluses of 0.25mg/kg as needed (88 subjects in this arm) and (b) Initial target effect-site concentration of 4mcg/ml, followed by target effect-site concentration of 2.5mcg/ml, titrating upward or downward by 0.5mcg/ml from baseline infusion rate as needed (88 subjects in this arm). Data will be collected using a data collection tool. Data analysis will be conducted using SPSS Version 21.0, Chicago-Illinois, and data analysed and summarized as appropriate.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied hypoxia,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/12/2016
Actual trial start date 23/01/2017
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date 31/03/2017
Anticipated target sample size (number of participants) 176
Actual target sample size (number of participants) 176
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2016/REC-41(v2) The Aga Khan University, Nairobi Research Ethics Commitee
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 randomization using a randomization 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 Target controlled infusion of Propofol Induction dose 4mcg/ml; maintenance infusion 2.5mcg/ml titrated to effect 5 - 10 minutes TCI Propofol induction dose 4mcg/ml, then maintenance 2.5mcg/ml titrated upward or downward by 0.5mcg/ml to maintain sedation depth at Ramsay Sedation Score 5 88
Control Group Intermittent bolus administration of Propofol Induction dose of 1mg/kg bolus, followed by intermittent boluses of 0.25mg/kg as needed. 5 - 10 minutes Induction IV bolus of 1mg/kg, followed by intermittent boluses of 0.25mg/kg as needed, to attain and maintain a Ramsay Sedation score of 5 for the duration of the procedure. 88
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All ASA I and II adults aged 18 - 65 years scheduled to undergo non-emergent upper gastrointestinal endoscopy under sedation. ¿Known allergy to propofol, midazolam, soybean, egg. ¿Active respiratory tract infection. ¿History or indicator of large airway compromise e.g. obstructive sleep apnoea, COPD, presence of stridor, or known history of difficult bag-valve-mask ventilation. ¿Patients requiring additional types of sedative agents to achieve optimal sedation. ¿History of chronic exposure to sedative medication. 18 Year(s) 65 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 21/12/2016 The Aga Khan University, Nairobi Research Ethics Committee(REC)
Ethics Committee Address
Street address City Postal code Country
P.O.BOX 30270 - 00100 Nairobi +254 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare the proportion of hypoxia between the two study groups Continuously, throughout the duration of the procedure.
Secondary Outcome To compare the proportion of hypotension and bradycardia between the two study groups At baseline. 2.5 minutes 5.0 minutes 7.5 minutes 10 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
The Aga Khan University Hospital, Nairobi 3rd Parklands Avenue Nairobi +254 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Aga Khan University research seed grant as approved by the Aga Khan University Nairobi Research Committee 3rd Parklands Avenue Nairobi +254 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Aga Khan University, Nairobi 3rd Parklands Avenue Nairobi +254 Kenya University
COLLABORATORS
Name Street address City Postal code Country
The Aga Khan University Hospital, Nairobi 3rd Parklands Avenue Nairobi +254 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Vitalis Mung'ayi mungayi@gmail.com +254023662157 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi +254 Kenya Consultant Anaesthesiologist
Role Name Email Phone Street address
Public Enquiries Ciru Kamanda research.supportea@aku.edu +254203662148 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi +254 Kenya Research Support Unit Administrator
Role Name Email Phone Street address
Scientific Enquiries Ednah Gisore gisoreednah@gmail.com +254203662157 3rd Parklands Avenue
City Postal code Country Position/Affiliation
Nairobi +254 Kenya Consultant Anaesthesiologist
REPORTING
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Result URL Hyperlinks Link To Protocol
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Changes to trial information