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.: PACTR202211634990263 Date of Registration: 24/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of the effect of intravenous and intra-cuff magnesium on post-extubation tracheal morbidity.
Official scientific title Comparison of the effect of intravenous and intra-cuff magnesium on post-extubation tracheal morbidity.
Brief summary describing the background and objectives of the trial Post extubation tracheal morbidity is a common complication after tracheal intubation . Its incidence ranges from 14-90% (2)(1) following endotracheal intubation and 5.8-34% after laryngeal mask insertion . Laryngotracheal morbidities following ETT extubation are associated with several negative outcomes including patient dissatisfaction, increased length of hospital stay, increased hospital cost and reduced bed turnover. Several studies have identified various means of reducing the occurrence of these morbidities . Amongst these findings are improvements in laryngoscopes and endotracheal tube properties(5), intra-cuff and intravenous lidocaine, topical airway and intravenous steroids, gargled NSAID’s nebulised and intravenous Ketamine. Magnesium which has anti-nociceptive and anti-inflammatory properties and can therefore play a role in reducing post extubation laryngotracheal morbidity. It is therefore not surprising to see the use of intravenous magnesium sulphate in preventing post extubation laryngotracheal morbidities in literature. Literature however does not show intra-cuff magnesium being proposed as a preventive measure for post extubation laryngotracheal morbidities. Objectives: 1. To determine and compare the incidence and severity of post-extubation laryngotracheal morbidity (sore throat, cough and hoarseness of voice) between patients who will have their ETT cuff filled with air, patients who will have their ETT cuffs filled with 2g Magnesium Sulphate and patients who will have their ETT cuffs filled with air and in addition receive 2g intravenous magnesium sulphate at induction. 2.To determine and compare the hemodynamic changes (Heart rate and Blood Pressure) during tracheal extubation between patients who will have their ETT cuff filled with air, patients who will have their ETT cuffs filled with 2g Magnesium Sulphate and patients who will have their ETT cuffs filled with air and in addition receiving 2g if intravenous magnesium sulphate.
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 01/04/2022
Actual trial start date 15/04/2022
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 06/10/2022
Anticipated target sample size (number of participants) 96
Actual target sample size (number of participants) 96
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A Endotracheal tube cuff was inflated with air to a pressure of 25cmH2O after intubation. The endotracheal tube cuff was inflated to 25comH20 after intubation and cuff was not deflated till extubation at the end of surgery Patients had their endotracheal tube (ETT) cuffs inflated with air to a pressure of 25cmH2O after intubation. 32 Placebo
Experimental Group Group B Patients had their ETT cuffs inflated with a 2g Magnesium Sulphate solution (4mls of 50% Magnesium Sulphate solution) after intubation. The solution was topped up with 0.9% normal saline to achieve the optimized pressure of 25cmH2O if needed. The endotracheal tube cuff pressure was inflated to 25cmH20 immediately after intubation and cuff was not deflated till extubation at the end of surgery Patients had their ETT cuffs inflated with a 2g Magnesium Sulphate solution (4mls of 50% Magnesium Sulphate solution). The solution was topped up with 0.9% normal saline to achieve the optimized pressure of 25cmH2O if needed. 32
Experimental Group Group C Patients had their ETT cuffs filled with air to a pressure of 25cmH2O as well as received 2g of intravenous Magnesium Sulphate in 20mls of 0.9% Normal saline perfused over 10 minutes at induction of general anaesthesia. 2g of intravenous Magnesium sulphate was perfused over 10 minutes at induction of general anaesthesia. The endotracheal tube cuff was inflated to 25cmH20 after extubation and not deflated till extubation at the end of surgery. Patients had their ETT cuffs filled with air to a pressure of 25cmH2O as well as received 2g of intravenous Magnesium Sulphate in 20mls of 0.9% Normal saline perfused over 10 minutes at induction of general anaesthesia. 32
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients above 18 years requiring endotracheal intubation 2. Patients with BMI <30 3. Patients with ASA classification I or II All elective general surgery patients requiring endotracheal intubation who meet above inclusion criteria and give a signed or thumb-printed informed consent to participate in this study will be included except: • Patients < 18years because they are incapable of giving informed consent by law. • Patients > 18years of age who are mentally incapacitated. • Patients with ASA III and IV, as these may be too sick with uncontrolled co-morbidities. • Patients who have an Upper Respiratory Tract Infection prior to surgery (sore throat, cough, running nose), as these may make assessment of tracheal morbidities difficult. • Patients coming for head and neck surgeries as manipulations during these surgeries could in themselves cause laryngeal morbidity. • Patients who will have their surgical cases done in the prone position. • Patients with a history of Asthma. These patients have a reactive airway and are prone to airway complications during intubation. • Patients with a history of difficult intubations, anticipated difficult intubation, and those who will have multiple attempts at intubation. • Patients with known anatomical laryngo-tracheal abnormalities, snoring and gastroesophageal reflux. • Patients who will require post-operative intubation and so cannot have the occurrence of tracheal morbidity 24 hours post-operatively assessed. • Patients who are obese (BMI >35kg/m2) ( they are high risk for difficult intubation and ventilation as well as develop airway complications more easily) Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 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 14/04/2022 Korle Bu Teaching Hospital Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
Korle-Bu Accra KB 77 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome It is expected that the subjects in the groups who had their ETT cuffs inflated with Magnesium Sulphate, or received intravenous Magnesium Sulphate, will have a reduction in the occurrence of post extubation sore throat, cough and hoarseness. 0 hours, 4hours, 8 hours, 12 hours and 24 hours after extubation
Secondary Outcome Heart rate and Blood pressures will be better controlled in the groups where the patients were given intravenous magnesium or intracuff magnesium Every 10 minutes for the duration of anaesthesia, immediately before and immediately after extubation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Korle Bu Teaching Hospital Korle-Bu Street Accra KB77 Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Naa Martekuor Vanderpuye MO Flat J1, Alexander Avenue, Korle-Bu Accra MP1647 Ghana
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Naa Martekuor Vanderpuye MO Flat J1 Alexander Avenue, Korle-Bu Accra 1647 Ghana Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Naa Martekuor Vanderpuye kokor2000@yahoo.com +233205182014 MO Flat J1 Alexander Avenue, Korle Bu
City Postal code Country Position/Affiliation
Accra MP1647 Ghana Specialist Anaesthesiologist
Role Name Email Phone Street address
Public Enquiries Ebenezer Owusu Darkwa eoddarquah@yahoo.com +233244670149 Department of Anaesthesia, Korle Bu Teaching Hospital, Korle-Bu
City Postal code Country Position/Affiliation
Accra KB77 Ghana Supervisor
Role Name Email Phone Street address
Scientific Enquiries Robert Djagbletey r_djag@yahoo.com +233244604456 Department of Anaesthesia, Korle Bu teaching Hospital, Korle- Bu
City Postal code Country Position/Affiliation
Accra KB77 Ghana Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Will individual participant data be available? Yes Will data in particular be shared? All the individual participant data collected during the trial after deidentification. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication. No end date. Who will have access to this data? Anyone who wants to access the data will have access to the data. For what types of analyses? Any purpose. By what mechanism will data be made available? The data will be made available indefinitely
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