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.: PACTR201809642876909 Date of Approval: 11/09/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DIFFERENT ADMIXTURE DOSES OF KETOFOL IN ELECTIVE HEMRRHOIDECTOMY
Official scientific title DIFFERENT ADMIXTURE DOSES OF KETOFOL IN ELECTIVE HEMRRHOIDECTOMY
Brief summary describing the background and objectives of the trial Minor anorectal diseases are rather common. Hemorrhoids, anal fissures and fistulas are the most common. Anorectal surgery was graded as extremely painful and requires deep levels of anesthesia. Operations are usually performed on ambulatory basis with modern general anesthetics that provide smooth, quick, adjustable depth with lack of side effects and cost effectiveness. The use of a combination of Ketamine and Propofol (ketofol) has several anesthetic properties that may reach the level of idealism. Aim of the work: The aim of this study is to compare different ketofol admixture ratios to reach optimum anesthetic depth and to evaluate the effects on Hemodynamic parameters, Efficacy and intensity of sedation, Recovery profile till hospital discharge and Presence of side effects.
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 01/09/2018
Actual trial start date
Anticipated date of last follow up 31/10/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I Patients will receive Propofol: ketamine mixture 2:1 W/W; 1mg/kg of Propofol and 0.5mg/kg of ketamine in 20 ml syringe. once for i induction of anesthesia by the does mentioned then Rescue drug: 0.25 mg /kg of Propofol increments will be given if needed until optimum level of anesthesia is achieved and it could be repeated every 60 seconds. On arrival to the operating room basic non-invasive monitors will be connected. Peripheral intravenous line (20G) will be inserted. Oxygen will be administered via facemask (4L/min). Surgical procedure will start after the end of intravenous anesthetic mixture injection. 15 Dose Comparison
Experimental Group Group II patients will receive Propofol: ketamine mixture 3:1 W/W; 1.5mg/kg of Propofol and 0.5mg/kg of ketamine in 20 ml syringe. once in induction of anesthesia after induction with the mentioned does Rescue drug: 0.25 mg /kg of Propofol increments will be given if needed until optimum level of anesthesia is achieved and it could be repeated every 60 seconds. On arrival to the operating room basic non-invasive monitors will be connected. Peripheral intravenous line (20G) will be inserted. Oxygen will be administered via facemask (4L/min). Surgical procedure will start after the end of intravenous anesthetic mixture injection. 15
Experimental Group Group III Patients will receive Propofol: ketamine mixture 4:1 W/W; 2mg/kg of Propofol and 0.5mg/kg of ketamine in 20 ml syringe. once for induction after induction with the mentioned does Rescue drug: 0.25 mg /kg of Propofol increments will be given if needed until optimum level of anesthesia is achieved and it could be repeated every 60 seconds. On arrival to the operating room basic non-invasive monitors will be connected. Peripheral intravenous line (20G) will be inserted. Oxygen will be administered via facemask (4L/min). Surgical procedure will start after the end of intravenous anesthetic mixture injection. 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA physical status I and II aged 18-40 years old scheduled for elective hemorrhoidectomy under sedation will be enrolled in this study. Patient with history of sensitivity or allergy to the used drugs, Uncontrolled hypertension or ischemic heart disease, Addict Patients, patients on prolonged sedative drugs , complicated hemorrhoids with operative time extending 20 minutes and post-operative time that exceeds 24 hours will be excluded from the study. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 20 Year(s) 40 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
No 01/09/2018 Alexandria university ethic
Ethics Committee Address
Street address City Postal code Country
elmasala st Egypt 2347 Egypt
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 09/09/2018 alexandria university ethical comity
Ethics Committee Address
Street address City Postal code Country
elmasala st alexandria 4586 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Heart rate, mean arterial blood pressure (MABP), respiratory rate and arterial oxygen saturation will be recorded just before anesthesia and immediately after intravenous anesthetic mixture injection by 1minute in the lithotomy position and then every 5 minutes till the end of the procedure. Respiratory rate will also
Secondary Outcome Pain intensity will be evaluated in post-operative care unit by using Visual analogue pain scale (VAS) in the immediate postoperative period and every 2 hours till discharge from hospital). first analgesic requirement (defined as the time elapsed from the time of sedation injection till reaching VAS>4) will be recorded and treated by intravenous meperidine hydrochloride in a dose of 0.5mg/kg to keep VAS less than 4 , other side effects as hypotension ,Bradycardia, respiratory depression , nausea and vomiting will be also recorded. Recovery profiles: A. From the operating room to the post anesthetic care unit by Modified Aldrete Score B. From the post anesthetic care unit to the hospital ward by The post anesthetic Discharge scoring system (PADSS): C. From the hospital ward to home: Fast track 2014 used by song et al. after the end of the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria university elmasala st Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria university elmasala st Alexandria Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator yasser osman yasseralx@hotmail.com 01006357996 186 roshdy
City Postal code Country Position/Affiliation
Alexandria Egypt professor of anesthesia Alexandria university
Role Name Email Phone Street address
Public Enquiries ahmed saed ahmed289@hotmail.com 01005467435 23 tatar
City Postal code Country Position/Affiliation
Alexandria Egypt Alexandria university
Role Name Email Phone Street address
Scientific Enquiries kamilia salah eldean drkamilia11@yahoo.com 01257438890 786 kamola st
City Postal code Country Position/Affiliation
alexandria Egypt Alexandria University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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