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.: PACTR202401852393337 Date of Approval: 09/01/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Analgesia Nociceptive Index for in Cirrhotic Patients Undergoing Hepatic Resection
Official scientific title Analgesia Nociceptive Index for Nociception Monitoring in Cirrhotic Patients Undergoing Hepatic Resection: Randomized Control Trial
Brief summary describing the background and objectives of the trial Hepatic Resection is a major abdominal surgery associated with significant derangement in physiology, including a catabolic state, increased oxygen demand, impaired pulmonary function, persistent postoperative pain, One of Perioperative Elements of ERAS for Liver Resection is multimodal analgesia and decreasing stress response caused by surgical trauma, What can be monitored is nociception or the (patho-)physiological response to it. Analgesia Nociception Index (ANI) is a dimensionless score (0-100) based on the analysis of the area under the curve of the high frequency spectrum of the heart rate variability (HRV) as it predominantly mediated by the parasympathetic system objectives The goal of this study is to investigate the ability of analgesia nociceptive index (ANI) compared to traditional method(elevated heart rate and mean blood pressure) to decrease opioid consumption during hepatic focal lesion resection
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ANI
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/03/2022
Actual trial start date 01/03/2022
Anticipated date of last follow up 01/04/2023
Actual Last follow-up date 01/04/2023
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL international anasthesia 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 control group all over the operation control group opioid will administered when HR and MBP increased more than 20 ٪ than baseline Measurement Measurement times during the perioperative course of liver resection: baseline before anesthesia (T0), after induction of general anesthesia (T1), after intubation (T2), at the skin incision (T3), every one hour till the end of surgery (T4-7) at the end of surgery (T8) 5min after extubation in the operation room (T9) In control group opioid will administered when HR and MBP increased more than 20 ٪ than baseline Measurement times during the perioperative course of liver resection: baseline before anesthesia (T0), after induction of general anesthesia (T1), after intubation (T2), at the skin incision (T3), every one hour till the end of surgery (T4-7) at the end of surgery (T8) 5min after extubation in the operation room (T9) 20 Placebo
Experimental Group ANI group In analgesia nociception index (ANI) group opioid will administered to maintain ANI above 50 operation time. baseline before anesthesia (T0), after induction of general anesthesia (T1), after intubation (T2), at the skin incision (T3), every one hour till the end of surgery (T4-7) at the end of surgery (T8) 5min after extubation in the operation room (T9) In analgesia nociception index (ANI) group opioid will administered to maintain ANI above 50 Measurement times during the perioperative course of liver resection: baseline before anesthesia (T0), after induction of general anesthesia (T1), after intubation (T2), at the skin incision (T3), every one hour till the end of surgery (T4-7) at the end of surgery (T8) 5min after extubation in the operation room (T9) 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1.cirrhotic patients candidate for hepatic resection 2. Child classification (A) 1.patients suffered from Major intraoperative events (e.g. severe hemodynamic instability, massive blood loss, . 2. Allergic patients to any of the study drugs, Opioid addiction, 3. Body-mass index higher than 40 kg/m²and 4. when ANI measurement cannot be interpreted arrhythmia, pace maker (certain types) heart transplant drugs affecting the sinus node (atropine and other anticholinergic drugs, Adult: 19 Year-44 Year,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 ability of analgesia nociceptive index (ANI) compared to traditional method(elevated heart rate and mean blood pressure) to decrease opioid consumption during hepatic focal lesion resection 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 surgery
Secondary Outcome haemodynamic changes . postoperative complication 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 surgery
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 abdelghafar shebeen elkoom 23456 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor national liver institute yassen abdelghafar shebeen abdelghafar 23456 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
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 anasthesia lecturer
Role Name Email Phone Street address
Public Enquiries hanaa rashed hanaarashed2020@yahoo.com 01001378542 yassen abdelghafar
City Postal code Country Position/Affiliation
shebeen elkom 23456 Egypt anasthesia 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
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes the summary ,patients data , study protocol ,methodology and aim of the work , the results when be available will be shared for public Study Protocol when the result will be available within one year study protocol. investigator
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