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.: PACTR202011865064201 Date of Approval: 12/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title opiod free anethesia versus opioid based anethesia in scoliosis surgery
Official scientific title Analgesic effect of opioid free total intravenous anesthesia versus opioid based total intravenous anesthesia in scoliosis surgery. A prospective randomized trial.
Brief summary describing the background and objectives of the trial Scoliosis surgery is a major procedure associated with intense pain, high doses of opioids are frequently required.Perioperative opioids are associated with nausea and vomiting, sedation, ileus, delirium, respiratory depression, increased postoperative pain and hyperalgesia. .Opioid free anethesia is used to avoid opioids side effects and acheive better analgesia. The aim of study is to evaluate the analgesic effect of opioid free anethesia in scoliosis sugery
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial pain management
Anticipated trial start date 15/11/2020
Actual trial start date
Anticipated date of last follow up 15/04/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants)
Recruitment status Not yet 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 Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group general anethesia Induction with loading fentany 1 µg/kg over 10 minutes then propofol 2.5 − 3.5 mg/kg, followed by atracurium 0.5 mg/kg Maintainance with continuous infusion of fentanyl 0.5 µg/kg/h and continuous infusion of propofol 50 − 200 µg/kg/min during surgery anesthesia will be induced with loading fentany , propofol and atracurium for tracheal intubation, and maintained with continuous infusion of fentanyl and propofol 50 − 200 µg/kg/min for maintaining bispectral index (BIS) between 40 and 60.After intubation, patient will be mechanically ventilated with an oxygen–air mixture to maintain end‑tidal CO2 between 35 and 40 mmHg monitored by capngram . At the end of surgery neuromuscular blockade will be reversed using intravenous neostigmine and atropine , extubation and transference of patient to postanesthesia care unit and fellowup. 25 Placebo
Experimental Group general anethesia opioid free Induction with loading dose of dexmedetomidine 1µg/kg over 10 min, propofol 2.5 − 3.5 mg/kg, followed by atracurium 0.5 mg/kg, and will be Maintained with continuous infusion of propofol 50 − 200 µg/kg/min and dexmedetomidine 0.3 _0.5 µg/kg/h Ketamine infusion 0.1- 0.3 mg/kg /hour Lignocaine 1.5 mg/kg will be administered at induction and an infusion of 2 mg/kg/h will be started after the loading dose. during surgery after a loading dose of dexmedetomidine anesthesia will be induced with propofol atracurium edotracheal tube will be inserted .After intubation, patient will be mechanically ventilated with an oxygen–air mixture to maintain end‑tidal CO2 between 35 and 40 mmHg monitored by capngram anesthesia maintained with continuous infusion of propofol , dexmedetomidine ,Ketamine infusion and lignocaine infusion. At the end of surgery neuromuscular blockade will be reversed using intravenous neostigmine and atropine Extubation will be done and patient transfered to PACU for fellowup 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- 50 patients of both sexes, 2- American society of anesthesia (ASA) physical state class I–II. 3- aged from 10 to 18 years. 4-Scheduled for surgical correction of scoliosis under general anesthesia 1- patients , guardian refusal. 2- preexisting neurological or psychiatric illness. 3- hepatic or renal insuffuicieny or haematological disorder 4- contraindication or allergy to study medications 5-unstable cadiorespiratory disorder or any degree of heart bock. 6-chronic use of opioids Adolescent: 13 Year-18 Year,Child: 6 Year-12 Year 10 Year(s) 18 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 21/10/2020 Research Ethics Committe
Ethics Committee Address
Street address City Postal code Country
Elgeish street Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the proportion of patients requiring intraoperative rescue analgesia. intraoperative
Secondary Outcome Time to first postoperative rescue analgesia 24 hours postoperative
Secondary Outcome Side effects like PONV and respiratory depression. 24 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta University Faculty of medicine Elgeish street Tanta 31527 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Shimaa Elrahwan Dr Maram Elmazny Dr Laila Alahwal elgeish street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Shimaa Mostafa Elrahwan ELgeish street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Shimaa Mostafa Elrahwan Elgeish Tanta 31527 Egypt
Maram Ibrahim Elmazny Elgeish street Tanta 31527 Egypt
Laila Ahmed Elahwal Elgeish Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shimaa Elrahwan shimaarahwan1184@gmail.com +201007186300 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries Maram Elmazny maramelmazny705@gmail.com +201014137093 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
Role Name Email Phone Street address
Public Enquiries laila Elahwal lailaelahwal@gmail.com +201018484319 Elgeish
City Postal code Country Position/Affiliation
Tanta 31527 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes statistics of age, sex, intraoperative analgesic consumption time to first analgesic request and complication Statistical Analysis Plan IPD will be shared after finishing the study and publication of the study and it will be available for one year IPD will be available for scientific research only on e-mail request . request will be sent to e-mail of principal investigator ( shimaarahwan1184@gmail.com)
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