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.: PACTR202007844671903 Date of Approval: 17/07/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title opioid free anaesthesia in abdominal gynacological surgery
Official scientific title Opioid free versus opioid based anaesthesia in abdominal gynecological surgery: A prospective randomized controlled trial.
Brief summary describing the background and objectives of the trial Gynecological surgeries are some of the most frequent surgeries. Analgesia is a one of general anaesthesia componenet, Opioids used for long time to provide analgesia for surgical patient while it is not free of complications. so, opioid free anaesthesia introduced to achive alternative solution
Type of trial RCT
Acronym (If the trial has an acronym then please provide) opioid
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 08/07/2020
Actual trial start date
Anticipated date of last follow up 10/09/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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 opioid free anaesthesia 0.5 mg/kg ketamine IV loading dose once 1.5 mg/kg lidocaine as loading dose followed by infusion of lidocaine 1.5mg/kg/h. IV 1gm of paracetamol IV once dexamethasone 8 mg IV once intraoperative 0.5 mg/kg ketamine IV loading dose once at anaesthesia induction 1.5 mg/kg lidocaine as loading dose followed by infusion of lidocaine 1.5mg/kg/h. IV 1gm of paracetamol IV once post induction dexamethasone 8 mg IV once post induction 25
Control Group opioid anaesthesia -Fentanyl 1 mic/kg in as loading dose followed by infusion 1 μg/kg/h. dexamethasone 8 mg 1gm of paracetamol intraoperative -Fentanyl 1 mic/kg in as loading dose followed by infusion 1 μg/kg/h. dexamethasone 8 mg IV once post induction 1gm of paracetamol IV once post induction 25 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 • 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 02/07/2020 IRB mansoura university
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 pain assessment (VAS score). 0H,1H, 2H, 4H, 6H, 12H, 24H post operative
Secondary Outcome total pethidine consumption 24H. post operative
Secondary Outcome nausea, vomiting, ileus and constipation. 24h. postoperative
Secondary Outcome Recovery time and postoperative respiratory depression. 0 H. postoperative
Secondary Outcome HR, MABP, Spo2 0,15,30,45,60,75,90,105,120,135,150 min intraoperative, 0H,1H, 2H, 4H, 6H, 12H, 24H post operative
Secondary Outcome sedation score RASS 0,1 H. POST OPERATIVE
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospital elgomhoria street elmansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed adel mohamed aboelela....lecturer of anaesthesia faculty of medicine mansoura university 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 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 anaesthesia 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 anaesthesia 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 anaesthesia and SICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes study design, methods ,results Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 months after completion of study through IRB mansoura university
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