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.: PACTR202002851765619 Date of Approval: 11/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effectiveness of intravenous lidocaine for prevention of suxamethonium induced fasciculation and myalgia in patient undergoing elective surgery under general anesthesia at Dilla University Referral Hospital, Southern Ethiopia, 2020.
Official scientific title Effectiveness of intravenous lidocaine for prevention of suxamethonium induced fasciculation and myalgia in patient undergoing elective surgery
Brief summary describing the background and objectives of the trial Suxamethonium has been a commonly used muscle relaxant for endotracheal intubation in developing countries including Ethiopia due to low price, easily availability, short onset time and short duration of action. But the routine uses of suxamethonium has been abandoned in developed countries because of a number of side effects e.g. bradycardia, hyperkalemia, fasciculation and post-operative myalgia. However, fasciculation immediately after induction of anesthesia and subsequent myalgia in postop erative period outnumber the rest. Even through fasciculation is benign and self-limiting in otherwise healthy patients, fasciculation might be associated with intracranial hypertension in head injury patient, increased intra ocular pressure in open eye surgery and increased the risk of aspiration in full abdomen patients. Postoperative Myalgia is usually distressing for the patients and it can delay patient from hospital discharge. The main objective of this study is to assess effectiveness of lidocaine for prevention of suxamethonium induced fasciculation and postoperative myalgia in a patient undergoing elective surgery under general anesthesia in Dilla university referral hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/02/2020
Actual trial start date
Anticipated date of last follow up 03/01/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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 by using procedures such as coin-tossing or dice-rolling 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 LIDOCAINE GROUP 1.5 mg/kg 3 minutes before induction 1.5 mg/kg 2% plain lidocaine given 3 minutes before induction of anesthesia 30
Control Group NORMAL SALINE equal volume with experimental drug will be drawn 3 minutes before induction equal volume with experimental drug will be drawn 30 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Elective ASA I & ASA II patients Age between 18 and 60 years Undergoing Laparotomy surgery Neuromuscular disease Open eye injuries Head injury and brain tumor 2nd and 3rd trimester pregnant mother, Preoperative opioid intake DM patients Preexisting hyperkalemia Recent history of third degree burn \Allergic to local anesthetics Adult: 19 Year-44 Year 18 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 04/06/2019 Dilla University Collage of Medical Health Sciences Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
04 Dilla 0013 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Incidence of post-operative myalgia Within 72 hours
Secondary Outcome Incidence of fasciculation after administration of suxamethonium
Secondary Outcome Severity of fasciculation After administration of suxamethonium
Secondary Outcome Severity of myalgia 6 hour, 12 hours , 24 hours, 48 hours and 72 hours after completion of surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
DILLA UNIVERSITY REFERRAL HOSPITAL 0014 DILLA 00419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
DILLA UNIVERSITY 0014 DILLA 0013 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DILLA UNIVERSITY 0014 DILLA 0013 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
SIMENEH MOLA 0014 DILLA 0014 Ethiopia
BEDRU JEMAL 0017 DILLA 0015 Ethiopia
ZEMEDU AWEKE 0015 DILLA 0017 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator SIMENEH MOLA ksimenehmola@yahoo.com +251901091414 0014
City Postal code Country Position/Affiliation
DILLA 0014 Ethiopia Lecturer
Role Name Email Phone Street address
Public Enquiries BEDRU JEMAL bedruanst@gmail.com +251924415702 0017
City Postal code Country Position/Affiliation
DILLA 0017 Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries ZEMEDU AWEKE zemeduawoke@gmail.com +251912406236 0015
City Postal code Country Position/Affiliation
DILLA 0015 Ethiopia Lecturer
Role Name Email Phone Street address
Scientific Enquiries TESFANEW BEKELE Elhanantb@gmail.com +251911423932 05
City Postal code Country Position/Affiliation
DILLA 0049 Ethiopia Assistance professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes we will share all necessary data upon request Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol within 2 years open
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