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.: PACTR202208588389635 Date of Approval: 11/08/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of small dose Ketamine on Deep Sedation for Endoscopy Patients
Official scientific title Evaluation of Paradoxical Effect of Small Dose Ketamine as Adjuvant in Deep ‎‎‎Sedation for Endoscopy Patients: Prospective Randomized Trial
Brief summary describing the background and objectives of the trial Some studies explored the paradoxical effect of a small dose of Ketamine in accelerating recovery from anesthesia. Our study aims to test this finding in the setting of gastrointestinal ‎endoscopies where subanesthetic doses of Ketamine are frequently used in sedation ‎of upper gastrointestinal and colonoscopic endoscopies.‎
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 14/08/2022
Actual trial start date
Anticipated date of last follow up 14/12/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 154
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
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 Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group PK a single dose of Ketamine (0.1 mg/kg) at the beginning of the procedure ‎ A single shot over 10 - 20 seconds, given once a single intravenous dose of Ketamine preoperatively 77
Control Group Group P Saline 0.05 ml/kg once at the beginning of the procedure A single shot over 10 - 20 seconds, given once a single intravenous dose of saline preoperatively 77 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The patients will be of ASA physical status I-II, age between 20 to 60 years of age, body weight 50 – ‎‎100 kg (BMI 20 - 35)‎ Patients with history of seizures, ‎ patients presenting with tachycardia (above 110 ‎beats/min), or any arrhythmic pattern or hypotension (below 90/60 mm Hg), ‎moderate to severe renal or hepatic impairment‎ Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 06/07/2022 Research Ethics Committee Ain Shams University Faculty of Medicine
Ethics Committee Address
Street address City Postal code Country
Abbasia Square Cairo 11517 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time to reach Modified Aldrete Score (MAS) >9 ‎ At the end of procedure, in the PACU room
Secondary Outcome Level of sedation on Ramsay Assessment Scale for the level of sedation‎ RSS During procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Hospitals Abbasia Square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohammed Maarouf Isthimari - Mostaqabal Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Hospitals Abbasia Square Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed Maarouf mm.maarouf@med.asu.edu.eg +201006469268 Isthimari - Mostaqabal
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University Faculty of Medicine
Role Name Email Phone Street address
Public Enquiries Mohammed Maarouf mm.maarouf@med.asu.edu.eg +201006469268 Isthimari - Mostaqabal
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University Faculty of Medicine
Role Name Email Phone Street address
Scientific Enquiries Mohammed Maarouf mm.maarouf@med.asu.edu.eg +201006469268 Isthimari - Mostaqabal
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams University Faculty of Medicine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through the study may be provided to qualified researchers with academic interest in sedation for gastrointestinal endoscopy. Data shared will be coded with no patient health information included. Study Protocol Data requests can be submitted starting 6 months after article publication and the data will be made accessible for upto 24 months. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research. For more information or to submit a request, please contact: mm.maarouf@med.asu.edu.eg
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