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.: PACTR202402578309242 Date of Approval: 20/02/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Dexmedetomidine as an Adjuvant to Desflurane Anesthesia on Hepatocellular Functions in Patients with Chronic Liver Disease Undergoing Lower Abdominal Surgery
Official scientific title The Effect of Dexmedetomidine as an Adjuvant to Desflurane Anesthesia on Hepatocellular Functions in Patients with Chronic Liver Disease Undergoing Lower Abdominal Surgery: A Randomized Controlled Study
Brief summary describing the background and objectives of the trial Hepatitis C virus (HCV) infection poses a formidable public health challenge in Egypt, a nation characterized by the highest global prevalence of HCV. The country exhibits unique attributes in terms of historical context, epidemiological characteristics, genotype distribution, and healthcare models. To the best of our knowledge, no research has focused on the combined effects of dexmedetomidine and desflurane anesthesia on liver function in cirrhotic patients undergoing lower abdominal surgery. A large number of elective extrahepatic surgical procedures are performed daily on chronic hepatitis C patients in Egypt. This requires a thorough study of the changes that may occur in liver functions during the initial postoperative period, to find better anesthetic techniques, as well as to investigate the drug interactions and side effects. The present study aimed to evaluate the impact of dexmedetomidine (Dex) supplementation to desflurane anesthesia on hepatocellular functions in patients afflicted with chronic liver disease undergoing elective lower abdominal surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
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 01/12/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 30/11/2021
Anticipated target sample size (number of participants) 82
Actual target sample size (number of participants)
Recruitment status Completed
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
Experimental Group Dexmedetomidine Over 15 min before induction of general anesthesia. Then during the procedure until 15-20 minutes before the end of the procedure. Lactated Ringer's solution (500 mL) was infused as a preload and then at a rate of 6-8 mL/kg/h during surgery to maintain and replace deficits. Patients were preoxygenated with 100% oxygen by face mask for approximately three minutes. Patients received dexmedetomidine HCl (200 µg/2 mL diluted with 18 mL saline) at a dose of 0.4 μg/kg/h via an infusion pump over 15 minutes prior to induction of general anesthesia. A maintenance infusion of dexmedetomidine at a dose of 0.1 μg/kg/h was then administered during surgery, to be discontinued approximately 15-20 minutes before completion of surgery. 41
Control Group Placebo Over 15 min before induction of general anesthesia. Then during the procedure until 15-20 minutes before the end of the procedure. Same as the intervention group except that dexmedetomidine was not administered (patients received similar volumes of saline). 41 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male and female Aged 30-60 years BMI between 18 and 35 Kg/m2 Child-Pugh-Turcotte class A ASA physical status classes II or III Scheduled for elective lower abdominal surgery Spontaneous bacterial peritonitis Complicated cholecystitis Disseminated malignant tumor Cardiovascular disease Renal failure requiring dialysis Child-Pugh-Turcotte class B or more INR > 1.5 Platelets count ≤ 50,000/mm3 Tense or refractory ascites Serum sodium ≤ 120 mEq/l Allergy for the study’s medications Neurological or mental disease Bronchial asthma Hematological disorder (not caused by chronic liver disease) Pregnancy Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 30 Year(s) 60 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 30/11/2020 Ethical Committee of Theodor Bilharz Research Institute
Ethics Committee Address
Street address City Postal code Country
Warraq Al Arab, Al Warak Giza 12411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gamma-glutamyl transpeptidase level Preoperatively and at 24 and 48 hours after the end of surgery
Secondary Outcome Liver function tests including AST, ALT, LDH, serum albumin, serum bilirubin (total & direct). Preoperatively and at 24 and 48 hours postoperatively.
Secondary Outcome Hemodynamic parameters including heart rate, systolic, diastolic and mean arterial pressure. Preoperatively, after anesthesia induction, at 5, 10, 15, 30, 45, and 60 min intraoperatively, at 15 and 30 min postoperatively, and after discharge from PACU
Secondary Outcome Ramsay Sedation Score Postoperatively
Secondary Outcome Patient satisfaction score Postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Theodor Bilharz Research Institute Warraq Al Arab, Al Warak Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Hassan Mohammed Warraq Al Arab, Al Warak Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Theodor Bilharz Research Institute Warraq Al Arab, Al Warak Giza Egypt Research institute
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Mohammed ahmed.hassan.mohammed@email.com +201000343057 Warraq Al Arab, Al Warak
City Postal code Country Position/Affiliation
Giza Egypt Anesthesiology Surgical Intensive Care and Pain Medicine Department Theodor Bilharz Research Institute
Role Name Email Phone Street address
Scientific Enquiries Heba Bakr heba.bakr@email.com 0000000000000 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Amr Abd El Monaem abdelmonaem.a@email.com 0000000000000 Kasr Al Ainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated during and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol From 12 to 24 months after article publication Data will be accessible on reasonable request through direct contact with the corresponding author, to be used for systematic reviews or meta-analyses.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 19/02/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 19/02/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information