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.: PACTR202301766708922 Date of Approval: 16/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Opioid-free anesthesia monitored by analgesia nociceptive index for hepatectomy in cirrhotic
Official scientific title Opioid-free anesthesia monitored by analgesia nociceptive index for cirrhotic patients undergoing hepatic focal lesion resection
Brief summary describing the background and objectives of the trial Liver cirrhosis reduced hepatocellular function. As hepatic enzyme formation is required for medicine metabolism, , high sensitivity and drug harmlessness may occur in patient diminished hepatic synthesis. Cirrhotic patients can benefit from opioid free anesthesia (OFA) as they are most sensitive to opioids' side effects.OFA is a multimodal procedure associating non-opioid drugs and regional anesthesia techniques that allow a better quality of anesthesia with patient satisfaction. Aim of the study The goal of this study is to investigate the analgesic effect of OFA in cirrhotic patients scheduled for hepatic focal resection compared to opioid based anesthesia by Analgesia Nociception Index
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OFA ANI
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2022
Actual trial start date 01/12/2022
Anticipated date of last follow up 01/12/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Recruiting
Publication URL anasthesia and analgesia journal
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
Experimental Group opioid free anesthesia group anesthesia willbe started with Dexmetedomidine infusion ( 0.9 µg/kg/h) for 10 minutes during which bilateral Erector Spiane block guided by ultrasound at the level of thoracic vertebrae (T 6-7)will be done. The local anesthetic dose will be 20ml Bupivacaine 0.25% with additive Dexametedomidine (0.5µg/kg) on each side. intraoperative and postoperative In the study group (OFA group) anesthesia willbe started with Dexmetedomidine infusion ( 0.9 µg/kg/h) for 10 minutes during which bilateral Erector Spiane block guided by ultrasound at the level of thoracic vertebrae (T 6-7)will be done. The local anesthetic dose will be 20ml Bupivacaine 0.25% with additive Dexametedomidine (0.5µg/kg) on each side. a dose of Propofol (1.5-2 mg/kg), Rocuronium (0.9 mg/kg), Xylocaine 60 mg, Magnesium sulfate 1gm will infused with the induction and followed by tracheal intubation. For maintenance Dexmetedomidine infusion (0.2-0.7 µg/kg/h) were used to obtain appropriate hemodynamics. 25
Control Group opioid based anasthesia intravenous dose of Propofol (1.5-2 mg/kg), Fentanyl 2µg/kg and Rocuronium will be administered (0.9mg/kg) to facilitate tracheal intubation. Then opioids will be used in the maintenance of anesthesia to maintain appropriate hemodynamics. intraoperative and postoperative after pre-oxygenation using O2/Air mixture (FiO2 =0.8) for 3-5min, general anesthesia was induced with an intravenous dose of Propofol (1.5-2 mg/kg), Fentanyl 2µg/kg and Rocuronium will be administered (0.9mg/kg) to facilitate tracheal intubation. Then opioids will be used in the maintenance of anesthesia to maintain appropriate hemodynamics. 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
cirrhotic patients candidate for hepatic resection with Child classification (A) 1-patients suffered from Major intraoperative events (e.g. severe hemodynamic instability, massive blood loss, massive blood products transfusion). 2-Allergic patients to any of the study drugs. 3- Opioid addiction. 4-Body-mass index higher than 40 kg/m². 5-unwilling to participate in the study. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 01/02/2022 insitution review board of national liver institute
Ethics Committee Address
Street address City Postal code Country
yassen abdelghafar shebeen elkom 23456 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome investigate the analgesic effect of OFA in cirrhotic patients scheduled for hepatic focal resection compared to opioid based anesthesia by Analgesia Nociception Index base line baseline before anesthesia , after induction of general anesthesia , after intubation , at the skin incision , every one hour till the end of surgery at the end of sur
Secondary Outcome hemodynamic effects base line baseline before anesthesia , after induction of general anesthesia , after intubation , at the skin incision , every one hour till the end of surgery at the end of sur
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national liver institute yassen abdelghafar shebeen elkoom 23456 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
national liver institute yassen abdelghafa shebeen elkoom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver street yassen abdelghafar shebeen abdelghafar 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
mennatallah ali yaseen abdelghafar shebeen elkom 23456 Egypt
nagwa ibraheem yaseen abdelghafar shebeen elkom 23456 Egypt
maha lotfy yaseen abdelghafar shebeen elkom 23456 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator nagwa ibraheem nagwaibraheem85@yahoo.com 01002345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkom 23456 Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries mennatallah ali hanaarashed2020@yahoo.com 01002345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkom 23456 Egypt anasthesia lecturer
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 01002345678 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkom 23456 Egypt anasthesia lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we intend sharing study protocol , aim of the work, patient and method and the results when be available.sharing of de-identified individual trial participant data. Study Protocol when the result be available study protocol
URL Results Available Results Summary Result Posting Date First Journal Publication Date
international anasthesia journal 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