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.: PACTR202408620568675 Date of Approval: 08/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A Comparative Study Between Dexmedetomidine versus Magnesium Sulphate for Controlled Hypotensive Anesthesia in Rhinoplasty Surgeries.
Official scientific title A Comparative Study Between Dexmedetomidine versus Magnesium Sulphate for Controlled Hypotensive Anesthesia in Rhinoplasty Surgeries.
Brief summary describing the background and objectives of the trial Rhinoplasty is one of the most common cosmetic procedures performed in many countries, and bleeding during operation through the blood rich nasal mucosa obscures surgical field visibility and sometimes results in suboptimal surgical outcome. Application of the controlled hypotension improves operative field visibility and decreases the duration of surgery, total blood loss. Dexmedetomidine, an alpha2-agonist, has been used as a sedative, anxiolytic and hypotensive agent for anesthesia. It has been used for sedation in neuraxial anesthesia and also for postoperative pain management. The sedative and anxiolytic effects of dexmedetomidine are produced primarily via the stimulation of alpha2 adrenoceptors in the locus coeruleus of the pons. Its hypotensive effect is due to its sympatholytic effect of this alpha2 agonist, so results in decreasing heart rate and cardiac output without decreasing the stroke volume .While Magnesium sulfate is studied as a hypotensive agent for several years in different surgical procedures. It affects the regulation of sympathetic tone and blood pressure through blocking N-type and partially L-type calcium channels, and as a result inhibits norepinephrine release. Magnesium also acts as an N-methyl-D-aspartate (NMDA) receptor antagonist; therefore, it reduces analgesic and anesthetic requirements The aim of this work is to compare the efficacy of dexmedetomidine versus magnesium sulfate to control blood pressure during rhinoplasty and the resultant effects on the quality of surgical field in terms of bleeding and visibility.
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 Treatment: Drugs
Anticipated trial start date 20/07/2022
Actual trial start date 28/07/2022
Anticipated date of last follow up 29/08/2023
Actual Last follow-up date 31/08/2023
Anticipated target sample size (number of participants) 42
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dexmedetomidine Group A: On the arrival of the patient to the operating room, group A will receive a loading dose of 1 microgram/kg dexmedetomidine (Precedex, 200 microgram/2mL) diluted in 50 mL of saline 0.9% intravenously in 10 minutes before induction of anesthesia followed by continuous infusion of 0.4-0.6 microgram/kg/hour during the maintenance of anesthesia. both groups have loading dose before induction then a maintenance dose during the surgery Group A: On the arrival of the patient to the operating room, group A will receive a loading dose of 1 microgram/kg dexmedetomidine (Precedex, 200 microgram/2mL) diluted in 50 mL of saline 0.9% intravenously in 10 minutes before induction of anesthesia followed by continuous infusion of 0.4-0.6 microgram/kg/hour during the maintenance of anesthesia. Both groups will be compared to each other according to the following variables before induction of anesthesia, after intubation and then 5, 10, and 15 minutes after intubation and every 15 minutes intraoperative and recorded 2 minutes after epinephrine infiltration, at the end of surgery, after extubation, and every15 minutes during the PACU stay for one hour postoperative. 1. Heart rate. 2. Mean arterial blood pressure. 21
Control Group magnesium sulphate On the arrival of the patient to the operating room, group B will receive a loading dose of 40 mg/kg of magnesium sulfate diluted in 50 mL of 0.9% saline intravenously in 10 minutes before induction of anesthesia followed by continuous infusion of 10-15 mg/kg/hour during the operation. a loading dose of 40 mg/kg of magnesium sulfate diluted in 50 mL of 0.9% saline intravenously in 10 minutes before induction of anesthesia followed by continuous infusion of 10-15 mg/kg/hour during the operation. On the arrival of the patient to the operating room, group B will receive a loading dose of 40 mg/kg of magnesium sulfate diluted in 50 mL of 0.9% saline intravenously in 10 minutes before induction of anesthesia followed by continuous infusion of 10-15 mg/kg/hour during the operation. Group will be compared to each other according to the following variables before induction of anesthesia, after intubation and then 5, 10, and 15 minutes after intubation and every 15 minutes intraoperative and recorded 2 minutes after epinephrine infiltration, at the end of surgery, after extubation, and every15 minutes during the PACU stay for one hour postoperative. 1. Heart rate. 2. Mean arterial blood pressure. 21 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Patients of American Society of Anaesthesiologists (ASA) physical status I and II 2-Patients of both sex having age group between 18-60 years old electively scheduled for rhinoplasty under general anesthesia. 1. Refusal of the procedure or participation in the study. 2. Intraoperative hemodynamic instability. 3. Patients who require awake intubation. 4. Patients having hypertension or ischemic heart disease. 5. Patients with heart block, hepatic, renal and cerebral impairment, or with known coagulopathies. 6. Patients having history of allergy to the study drug used. 7. Patients on ACE inhibitors, α-2 adrenergic receptor blockers, Calcium channel blockers or beta blockers. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 16 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 02/09/2022 Research Ethical Committee at Faculty of Medicine Ain Shams University
Ethics Committee Address
Street address City Postal code Country
38 Abbassia Square, Next to Al Nour Mousque cairo 1181 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Heart rate. 2. Mean arterial blood pressure. Both groups will be compared to each other according to the following variables before induction of anesthesia, after intubation and then 5, 10, and 15 minutes after intubation and every 15 minutes in
Secondary Outcome 1-Surgical field will be assessed by the surgeon in terms of bleeding and visibility. 2-During postoperative period, the 2 groups will also be compared accordingly for the occurrence of the side effects as bradycardia, shivering, nausea, and vomiting to assess each drug effects on these side effect Surgical field will be assessed by the surgeon in terms of bleeding and visibility intraoperative and post operatively complications in the PACU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Medicine Ain Shams University 38 Abbassia Square,Next to Al-Nour Mousque Cairo 1181 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
The Principle Investigator 137 south acadamy, new cairo Cairo 4710001 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Primary Sponsor Faculty Of Medicine Ain Shams University cairo 1181 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sarah Amr Abbas Abdel halem 137 ganoub academy, new cairo cairo 4710001 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries sarah abdelhalem sarahabdelhalem@hotmail.com +201060702202 137 ganoub academy, new cairo
City Postal code Country Position/Affiliation
cairo 4710001 Egypt assistant lecturer of Anesthesia and intensive care at faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Principal Investigator ahmed khalifa ahmedkhalifa@gmail.com 01063825286 nasr city
City Postal code Country Position/Affiliation
cairo 1181 Egypt lecturer of Anesthesia and intensive care at faculty of Medicine Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries yasser abdel rahman yasserabdelrahman@hotmail.com 01099020165 abbas el akkad
City Postal code Country Position/Affiliation
cairo Egypt lecturer of Anesthesia and intensive care at faculty of Medicine Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual data collected during the trial , after de-identification Study Protocol period of availability: 2years any purpose
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