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.: PACTR202104853917277 Date of Approval: 12/04/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Lidocaine and ketamine as sole analgesics during laparoscopic cholecytectomy: efficacy and safety
Official scientific title Lidocaine and ketamine as sole analgesics during laparoscopic cholecytectomy: efficacy and safety
Brief summary describing the background and objectives of the trial Opioids are the corner stone of anesthesia but they can cause dose dependent side effects such as respiratory depression, postoperative nausea and vomiting , postoperative ileus, urinary retention and postoperative hyperalgesia, which could delay postoperative rehabilitation and increase the length of hospital stay. The goal of this study was to evaluate the efficacy of lidocaine and ketamine as a sole analgesic during laparoscopic cholecystectomy.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) OFA
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Efficacy and safety of anaesthesia drugs
Anticipated trial start date 12/11/2018
Actual trial start date 12/11/2018
Anticipated date of last follow up 15/01/2019
Actual Last follow-up date 31/12/2018
Anticipated target sample size (number of participants) 54
Actual target sample size (number of participants) 71
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 from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group LK group lidocaine 2% intraveinously (IV) 1.5 mg/kg at induction, then a continuous infusion of 2mg/Kg/h intraoperatively and ketamine (5mg/ml) an IV bolus of 0.5 mg/kg at induction, then continuous infusion of 0.05mg/kg/h . from induction of anaesthesia to the end of the surgical procedure and skin closure LK group received non-adrenalinized lidocaine 2% intraveinously (IV) 1.5 mg/kg at induction, then a continuous infusion of 2mg/Kg/h intraoperatively until the end of the surgical procedure and skin closure and ketamine (5mg/ml) an IV bolus of 0.5 mg/kg at induction, then continuous infusion of 0.05mg/kg/h with an increase of 0.05 mg/kg/h if heart rate increased by 20 % without exceeding 0.2 mg/kg/h until ablation of the vesicule. Boli of 1 µg /kg fentanyl were used if despite increasing ketamine doses, systolic blood pressure or heart rate raised over 20 % of the basal values when bispectral index values were between 40 and 60. 35
Control Group R group remifentanil diluted at 100 µg /ml induction dose: 1µg/kg over 1min then maintenance dose: 1 µg/kg/mn with an increase of 50µg/kg if heart rate increased by 20 % without exceeding 2µg/kg/h from induction of anaesthesia to the end of the surgical procedure and skin closure. R group received remifentanil diluted at 100 gamma /ml induction dose: 1µg/kg over 1min then maintenance dose: 1 µ/kg/mn with an increase of 50µg/kg if HR increased by 20 % without exceeding 2µg/kg/h until the end of the surgical procedure and skin closure. 31 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients of ASA (American Society of Anesthesiologists) physical status I or II, aged over 18 years, proposed for urgent or planned laparoscopic cholecystectomy giving written consent were enrolled. coronary artery disease, chronic pain requiring analgesics, heart rhythm disorders, beta-blockers, neurological and psychiatric disorders, known allergy to any of the products used in the protocol and pregnant or breastfeeding women. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 80 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 11/11/2018 LOCAL ETHICS COMMITTEE OF CHARLES NICOLLE HOSPITAL
Ethics Committee Address
Street address City Postal code Country
FORENSIC MEDICINE DEPARTMENT OF CHARLES NICOLLE HOSPITAL BAB SOUIKA 1006 TUNIS TUNIS 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Intraoperative hemodynamic parameters intraoperatively
Secondary Outcome postoperative adverse events postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
CHARLES NICOLLE HOSPITAL BOULEVARD DU 9 AVRIL 1938 TUNIS TUNIS 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
CHARLES NICOLLE HOSPITAL BOULEVARD DU 9 AVRIL 1938 TUNIS TUNIS 1007 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor CHARLES NICOLLE HOSPITAL BOULEVARD DU 9 AVRIL 1938 TUNIS TUNIS 1007 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ALIA JEBRI ALIA.JEBRI@GMAIL.COM 50803545 MOUROUJ 6 BEN AROUS
City Postal code Country Position/Affiliation
BEN AROUS 2074 Tunisia TEACHING HOSPITAL ASSISTANT LECTURER
Role Name Email Phone Street address
Scientific Enquiries HALLOUMA BEN FREDJ hallouma.benfredj@etudiant-fmt.utm.tn 25207433 AL IZ RESIDENCY EL GHAZELA CITY ARIANA
City Postal code Country Position/Affiliation
ARIANA 2083 Tunisia MEDICAL STUDENT
Role Name Email Phone Street address
Public Enquiries HALLOUMA BEN FREDJ hallouma.benfredj@etudiant-fmt.utm.tn 25207433 AL IZ RESIDENCY AL GHAZELA CITY ARIANA
City Postal code Country Position/Affiliation
ARIANA 2083 Tunisia MEDICAL STUDENT
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, afterdeidentification (text,tables, figures, and appendices) Informed Consent Form Immediately following publication, No end date Anyone who wishes to access the data
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