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.: PACTR201403000763411 Date of Approval: 06/02/2014
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title EFFECT OF ANAESTHESIA ON SERUM MAGNESIUM AND CALCIUM
Official scientific title The changes in serum magnesium and calcium concentrations during surgery: Comparing the effects of different anaesthetic techniques
Brief summary describing the background and objectives of the trial This is a prospective experimental study involving 165 surgical patients undergoing elective surgical procedure at the Lagos University Teaching Hospital aged 18-65 years. The patient scheduled for general anaesthesia will be randomily selected into two group via a computer generated random numbers. Group P will receive propofol, and group S will receive sodium thiopentone. All consecutive patients requiring subarachnoid block anaesthesia (group SAB) will be recruited into the study. Objectives To determine the changes in serum magnesium and calcium levels in the anaesthesied patient.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Surgery,surgical population
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 18/10/2013
Actual trial start date 21/10/2013
Anticipated date of last follow up 18/10/2014
Actual Last follow-up date
Anticipated target sample size (number of participants) 165
Actual target sample size (number of participants) 165
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ADM/DCST/HREC/1468 HUMAN RESEARCH ETHIC COMMITTEE OF LAGOS UNIVERSITY TEACHING HOSPITAL
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 COMPUTER GENERATED RANDOM NUMBER SIMPLE RANDOMISATION USING COMPUTER SOFTWARE PROGRAMME Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Group P patients will be induced with IV propofol 2mg/kg, and intubation will be facilitated with IV suxamethonium 1.5mg/kg AT INDUCTION patients will be induced with IV propofol 2mg/kg, and intubation will be facilitated with IV suxamethonium 1.5mg/kg, 1st sample will be withdrawn at preinduction, a 2nd sample will be taken 2 minutes after tracheal intubation, 3rd sample at 1 hour after incision, and a 4th sample immediately after surgery. Ion selective electrodes (SFRI Auto Analyzer) will be used to analyse ionized magnesium 55
Experimental Group Group SAB patients will receive subarachnoid block, 10ml/kg of 0.9% normal saline will be infused for 20-30 minutes as preload. The fourth and fifth lumbar (L4/L5) interspace will be identified; a 26 gauge spin AT INDUCTION Four blood samples will withdrawn, each specimen will contain 3mls of venous blood taken into a lithium heparin bottle.1st sample (preinduction), 2nd sample (2 minutes after establishing SAB), 3rd sample (1 hour after incision), 4th sample (after surgery). all sample sent for magnesium and calcium analysis 55
Control Group Group S IV sodium thiopentone 5mg/kg for induction, endotracheal intubation will be facilitated with suxamethonium 1.5mg/kg, AT INDUCTION Four blood samples will be withdrawn, each specimen will contain 3mls of venous blood taken into a lithium heparin bottle. 1st sample (preinduction), 2nd sample (2 minutes after intubation), 3rd sample (1 hour after incision), 4th sample (immediately after surgery). All samples for magnesium and calcium analysis 55 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
ASA I-II pateints, aged 18-65 years sheduled for elective surgery under general or spinal anaesthesia Children elderly ASA III-V patients patients with preoperative electrolyte abnormalities, abnormal albumin concentration, haemoglobin less than 10gm/dL refusal to participate in the studuncontrolled diabetes mellitus hypertension renal failure cardiac diseases known allergy to any of the anaesthetic agents. 18 Year(s) 65 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 18/10/2013 HUMAN RESEARCH ETHIC COMMITTE OF LAGOS UNVERSITY TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
109 ADMINISTRATIVE OFFICE, LAGOS UNVERSITY TEACHING HOSPITAL, IDI-ARABA LAGOS lagos +2341 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the changes in serum magnesium and calcium levels in the anaesthesied patient. at preinduction 2 minutes after endotracheal intubation or induction of subarachnoid block 1 hour after surgical incision immediately after surgery
Secondary Outcome 1. To determine if spontaneous ventilation continues following administration of the anaesthetic agents for sedation. 2. Pain (Yes/No), the participant will be monitored from the end of the procedure until sedation recovery during and after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS UNIVERSITY TEACHING HOSPITAL P.M.B 12003, SURULERE, LAGOS LAGOS +2341 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
AJAYI GODWIN DEPT OF GYNACOLOGY, LAGOS UNIVERSITY TEACHING HOSPITAL, LAGOS LAGOS +2341 Nigeria
PRENATAL DIAGNOSIS BIOMEDICAL ENGINEERING BLOCK, COLLEGE OF MEDICINE, UNIVERSITY OF LAGOS LAGOS +2341 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor PRENATAL DIAGNOSIS DEPT OF GYNAECOLOGY, LAGOS UNIVERSITY TEACHING HOSPITAL, LAGOS LAGOS +2341 Nigeria Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
AJAYI GODWIN DEPT OF GYNAECOLOGY, LAGOS UNIVERSITY TEACHING HOSPITAL, LAGOS LAGOS +2341 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator oyebola Adekola oyebolaadekola@yahoo.com +2348033242924 1 LUTH Road, Idi-araba, Surulere
City Postal code Country Position/Affiliation
lagos +2341 Nigeria Consultant Anaesthetist Lagos University Teaching Hospital
Role Name Email Phone Street address
Public Enquiries Godwin Ajayi goiajayi@yahoo.com +2347028409763 1 LUTH Road, Idi-araba, Surulere
City Postal code Country Position/Affiliation
lagos +2341 Nigeria Professor of Gynaecology/ Lagos University Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries John Olatosi tola_olatoai@yahoo.comy +2348023188630 1 LUTH Road, Idi-araba, Surulere
City Postal code Country Position/Affiliation
lagos +2341 Nigeria Consultant Anaesthetist/Lagos University Teaching Hospital
REPORTING
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