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.: PACTR202104461489716 Date of Approval: 21/04/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title local analgesic effect of subcutaneous ketamine
Official scientific title Preemptive subcutaneous ketamine as a sole agent , does it has a local effect in abdominal gynecological surgeries: A prospective randomized controlled study.
Brief summary describing the background and objectives of the trial Ketamine is a short-acting anesthetic drug that has analgesic properties at subanesthetic doses as an NMDA-receptor antagonist, new research has shown that ketamine has a local analgesic effect, and enhance the effect of local anesthetic drugs. This trial aims to asses the local analgesic effect of ketamine as a sole agent in abdominal gynecological surgeries.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ketamine
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 01/05/2021
Actual trial start date
Anticipated date of last follow up 06/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group incisional subcutaneous ketamine 100mg pre incisional I group: 20 ml syringe containing 100 mg ketamine dissolved in 20 ml saline, for subcutaneous injection at the incision site after anaesthesia induction 5 minutes before starting surgery. A 3 ml syringe containing 2 ml saline will be injected subcutaneously at the upper outer area of the left arm as a placebo. 30
Control Group Remote subcutaneous ketamine 100 mg pre-incisional R group: 20 ml syringe containing 20 ml saline, for subcutaneous injection at the incision site after anaesthesia induction 5 minutes before starting surgery as placebo. 3 ml syringe containing 2 ml ketamine (100 mg) will be injected subcutaneously at the upper outer area of the left arm. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adult females ASA I or II aging 18-65 years undergoing abdominal gynecological surgery in mansoura university hospital • Patient refusal • Allergy to used drugs • Addiction • Altered liver or kidney function • Major cardiopulmonary disorder • Uncontrolled hypertension • Psychological problems. • Complicated procedure Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 65 Year(s) Female
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 10/04/2021 IRB mansoura university egypt
Ethics Committee Address
Street address City Postal code Country
elgomhoria street elmansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total pethedine consumption within the first 24 hours postoperative 24 hours postoperative
Secondary Outcome Pain assessment (VAS) 0,1,2,4,6,12,24 hours postoperative
Secondary Outcome HR, MABP 0,15,30,45,60,75,90,105,120,135,150 min introperative. 0,1,2,4,6,12,24 hours postoperative
Secondary Outcome • Gastrointestinal irritation symptoms( nausea, vomiting). • Un-anticipated complication like hallucination, vived dreams. 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elghomhoria sreet elmansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed adel aboelela khattab street elmansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university elgomhoria street elmansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
Role Name Email Phone Street address
Public Enquiries MOHAMED ABOELELA aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
Role Name Email Phone Street address
Scientific Enquiries mohamed aboelela aboelela_mohamed@yahoo.com 00201061546753 khattab street
City Postal code Country Position/Affiliation
elmansoura Egypt lecturer of anesthesia and SICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 5 years following article publication, with Researchers who provide a methodologically sound proposal Proposal should be directed to m_abouelela@mans.edu.eg. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (irb_staff@mans.edu.eg)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
irb_staff@mans.edu.eg 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