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.: PACTR201810759555893 Date of Approval: 22/10/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The prophylactic effect of intravenous magnesium infusion on postoperative sore throat after thyroid surgery
Official scientific title The prophylactic effect of intravenous magnesium infusion on postoperative sore throat after thyroid surgery
Brief summary describing the background and objectives of the trial Sore throat is a common complaint following general anesthesia (GA) with endotracheal intubation. It has been a source of considerable discomfort particularly in those patients who had thyroid surgery. We found a considerably higher incidence of postoperative sore throat (POST) after thyroid surgery when compared to general cases that did not involve neck surgery. Sanou et al. reported a greater incidence of sore throat after thyroid surgery compared to those who underwent other elective surgeries. Christensen et al. also reported a higher incidence of sore throat after thyroid surgery. The ultimate goal of postoperative sore throat control is to facilitate quick return to a functionally normal status The anti-sore throat effect of intravenous magnesium is achieved by their effect on NMDA receptors together with their anti-nociception and anti-inflammatory actions. Magnesium is a noncompetitive N-methyl-D-aspartate receptor antagonist thought to be involved in the modulation of pain. Aim of the work: The 1ry aim of the current study is to record the influence of perioperative magnesium administration on POST in thyroid surgery. The 2ry aims are intraoperative hemodynamics changes and perioperative analgesic consumption in addition to postoperative adverse effects and recovery profile.
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 Prevention
Anticipated trial start date 10/11/2018
Actual trial start date 10/11/2018
Anticipated date of last follow up 10/01/2019
Actual Last follow-up date 10/01/2019
Anticipated target sample size (number of participants) 80
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 a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Magnesium group The magnesium group received magnesium sulphate (30 mg/kg) in 100 ml of isotonic saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulphate infusion (15 mg/kg/h) for the duration of the operation. The magnesium group received magnesium sulphate (30 mg/kg) in 100 ml of isotonic saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulphate infusion (15 mg/kg/h) for the duration of the operation. The magnesium group received magnesium sulphate (30 mg/kg) in 100 ml of isotonic saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulphate infusion (15 mg/kg/h) for the duration of the operation. 40
Control Group Control group The control group received the same volume of isotonic saline, administered according to the same method as in the magnesium group. The control group received the same volume of isotonic saline, administered according to the same method as in the magnesium group. The control group received the same volume of isotonic saline, administered according to the same method as in the magnesium group. 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Eligibility criteria for this study included female patients, with a ranging age of age > 20 and < 50 years old, of American Society of Anesthesiologists physical status of I or II who were scheduled for total thyroidectomy for simple multinodular goiter under general anesthesia lasting for > one hour duration of surgery >3 hours, preexisting sore throat, corticosteroid use, or respiratory disease. pregnancy or breast feeding; body mass index > 30 kg/m2; significant heart, kidney, or liver disease; psychiatric or neurological disorders and hypersensitivity to magnesium Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 Year(s) Female
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 15/10/2018 FMASU R
Ethics Committee Address
Street address City Postal code Country
Abbaseya Cairo 11591 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome record the influence of perioperative magnesium adminstration on POST in thyroid surgery The incidence and grading of POST were evaluated at 1, 6 and 24 hours after surgery
Secondary Outcome Intraoperative analgesic consumption The total dose of intraoperative fentanyl was calculated for each patient
Secondary Outcome Recovery profile During extubation time period
Secondary Outcome Side effects as respiratory depression, emesis. hypotension, bradycardia On arrival to PACU then after 30 min and 1 hour from arrival to PACU
Secondary Outcome Postoperative pain 10, 30, and 60 minutes and at 2, 3, 6, 12 and 24 hours postoperatively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams university hospital 38 Abbaseya street Cairo 11591 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funding Ibn Hanbal Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams university Abbaseya Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Mohaamed Ibrahim El Rehab City Cairo Egypt
Ashraf Nabil Saleh Misr ElGedida Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Raham Hasan Mostafa rahamhasan@yahoo.com 20201222530020 Ibn Hanbal Street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams university
Role Name Email Phone Street address
Scientific Enquiries Ibrahim Mohamed Ibrahim hemotamam@hotmail.com 00966542145449 Elrehab city
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams university
Role Name Email Phone Street address
Public Enquiries Raham Hasan Mostafa rahamhasan@yahoo.com 20201222530020 Ibn Hanbal Street
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Anesthesia Ain Shams university
Role Name Email Phone Street address
Principal Investigator Ashraf Nabil Saleh ashraf_nabel@med.asu.edu.eg +0201001100613 Misr Elgedida
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer Ain Sams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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