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.: PACTR202109892575291 Date of Registration: 28/09/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effect of Intravenous Infusion of Dexmedetomidine versus Lidocaine as an Analgesic Adjuvant to Balanced General Anesthesia and Enhanced Recovery After Abdominal Surgery
Official scientific title The Effect of Intravenous Infusion of Dexmedetomidine versus Lidocaine as an Analgesic Adjuvant to Balanced General Anesthesia and Enhanced Recovery After Abdominal Surgery
Brief summary describing the background and objectives of the trial Comparative study between the effect of dexmedetomidine and lidocaine as adjuvant analgesics to balanced general anesthesia and their role in achieving enhanced recovery after 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 Treatment: Drugs
Anticipated trial start date 20/08/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 20/07/2020
Actual Last follow-up date 19/08/2020
Anticipated target sample size (number of participants) 140
Actual target sample size (number of participants) 140
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
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group dexmedetomidine  The dexmedetomidine group (Group D) will receive a 1ug/kg loading dose over 10 min immediately post-induction, followed by 0.5ug/kg/hr. The infusions will continue 24hr post bolus dose. 24 hours  The dexmedetomidine group (Group D) will receive a 1ug/kg loading dose over 10 min immediately post-induction, followed by 0.5ug/kg/hr. The infusions will continue 24hr post bolus dose. 70 Uncontrolled
Experimental Group The lidocaine group  The lidocaine group (Group L) will receive 1.5mg/kg loading dose over 5 min (lidocaine 2%) immediately post induction, followed by 1mg/kg/hr. The infusions will continue 24hr post bolus dose. 24 hours  The lidocaine group (Group L) will receive 1.5mg/kg loading dose over 5 min (lidocaine 2%) immediately post induction, followed by 1mg/kg/hr. The infusions will continue 24hr post bolus dose. 70
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients (age 21-55 years) • With body mass index (BMI) 18-25 Kg/m2. • ASA 1 and ASA 2 patients • Adequate cognitive state (able to understand and collaborate). • Patients that will undergo elective open abdominal surgery • Hypersensitivity to any of the used drugs • Pregnancy and lactating mothers • Chronic pain requiring daily use of opioid medication or chronic alcohol abuser • Sleep apnea syndrome. • Bradycardia (heart rate of fewer than 50 beats per min at rest) or patients on beta-blockers or alpha 2 agonists. • Epilepsy or chronic daily use of psychiatric medication • Patients received any other regional anesthesia technique (epidural, transverse abdominis plane (TAP) and Plexus block) • Re-exploration cases Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 21 Year(s) 55 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 20/08/2019 Faculty oft medicine Research Ethics Committee REC
Ethics Committee Address
Street address City Postal code Country
Abbassia Cairo Egypt cairo 11566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Total dose consumption of intraoperative opioids 24 hours
Secondary Outcome • Postoperative VAS score. • Time of the first rescue of analgesics • Total consumption of pethidine in the 24 hours. • vital signs ( heart rate, non-invasive arterial blood pressure, respiratory rate) • Number of episodes of nausea, vomiting (treated by IV bolus of metoclopramide 10 mg). • Time of return bowel movement, flatus. 24 hours
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University El-Khalyfa El-Mamoun Street cairo 11566 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Fatma Hassan Nozha street Cairo 11736 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Ain Shams Univeristy Hospital Abbasia Cairo Egypt cairo 11566 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Hadeel Magdy hadilmagdy2012@hotmail.com 00201001039233 cairo
City Postal code Country Position/Affiliation
Cairo Egypt Prof. Ain Shams University
Role Name Email Phone Street address
Public Enquiries Maha Sadek Mahasadek81@yahoo.com 0020114466675 abbasia cairo
City Postal code Country Position/Affiliation
cairo 11566 Egypt Lecturer
Role Name Email Phone Street address
Scientific Enquiries Amal Hamed rabieamal@yahoo.com 0020122833739 abassia cairo
City Postal code Country Position/Affiliation
cairo 11566 Egypt Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data was collected during the trial, after deidentification. Study Protocol Beginning 3 months and ending 2 years following article publication Researchers who provide a methodologically sound proposal.
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