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.: PACTR202408565688611 Date of Approval: 15/08/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Clonidine and dexmedetomidine for controlled hypotension during functional endoscopic sinus surgery: a comparative study
Official scientific title Comparison between clonidine and dexmedetomidine for controlled hypotension during functional endoscopic sinus surgery
Brief summary describing the background and objectives of the trial Nasal cavity and paranasal sinus diseases are mainly surgically treated by functional endoscopic sinus surgery (FESS) which is usually done as an ambulatory surgery. FESS is a minimally invasive procedure, fast and safe which involves the use of fiberoptic technology to visualize on videoscope the nasal cavity and sinuses while doing surgery. There is high risk of injuring close anatomic structures such as the brain, eye, carotid artery, nerves during FESS if there is major bleeding obscuring the surgical field visibility. The outcome of FESS strongly depends on surgical blood loss and field quality. Controlled hypotension during anesthesia is recommended to provide a better surgical field quality and minimize blood loss. Improved surgical field visibility decreases duration of surgery, and complications. Alpha-2 adrenergic agonists are preferred as adjuvant to total intravenous anesthesia for controlled hypotension in modern anesthesia. Their pharmacological action is mainly centrally mediated. They decrease MAP and HR and moreover they have anxiolytic, sedative and analgesic effects which decrease requirement in hypnotic, opioid and Minimal Alveolar Concentration (MAC) of inhalant anesthetic gases. Clonidine and recently dexmedetomidine are the two available alpha-2 adrenergic agonists used in modern hypotensive anesthesia There is little evidence on superiority (efficacy and safety) of dexmedetomidine compared to clonidine in terms of decreasing blood loss, surgical field quality and recovery profile during controlled hypotension in the setting of ambulatory surgery. The aim of this study was to evaluate the efficacy and safety of clonidine compared to dexmedetomidine for controlled hypotension during FESS. Secondary the study aimed at evaluating the blood loss and the quality of the surgical field; evaluating variations of hemodynamics parameters assessing the surgeon satisfaction and the level of patient sedation in the recovery room.
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: Devices
Anticipated trial start date 16/06/2021
Actual trial start date 16/06/2021
Anticipated date of last follow up 16/11/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants)
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
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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Clonidine μg/Kg of clonidine diluted in 10 ml 0.9% At induction Induction of Anaesthesia 40 Uncontrolled
Experimental Group Dexmedetomidine 1 μg/Kg of dexmedetomidine diluted in 10 ml 0.9% At induction Induction of Anaesthesia 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion criteria : • Age between 20 and 50 years • American Society of Anesthesiologists Physical Status I-II • Elective FESS Systemic Hypertension. • Anemia with hemoglobin concentration less than 10 gram per deciliter. • Patients with cardiac disease and arrhythmias. • Diabetes Mellitus. • Patient with medical history of stroke. • Patients with chronic kidney disease; liver diseases and coagulopathies or receiving drugs influencing blood coagulation. • Patient with known allergy on dexmedetomidine or clonidine; • Obesity Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 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 15/07/2021 Ethics Committee Faculty of Medicine Alexandria University
Ethics Committee Address
Street address City Postal code Country
22 El-Gaish Rd, Al Azaritah WA Ash Shatebi, Bab Sharqi, Alexandria Governorate Alexandria 5424041 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Blood loss During surgery
Secondary Outcome The Mean Arterial Blood Pressure During surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Alexandria University Main teaching hospital 1 Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
No funding 00 Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor No sponsor 00 Alexandria Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Erick Namegabe Mugabo namegabem@gmail.com +243979220490 00, Vamaro, Bukavu, RD Congo
City Postal code Country Position/Affiliation
Bukavu Democratic Republic of the Congo Consultant
Role Name Email Phone Street address
Public Enquiries Ragab Saad Beltagy beltagyragab@gmail.com +201004981981 22 El-Gaish Rd, Al Azaritah WA Ash Shatebi, Bab Sharqi, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria Egypt Consultant
Role Name Email Phone Street address
Scientific Enquiries Rania Ake Fatteli saaroro2@gmail.com +201001394019 22 El-Gaish Rd, Al Azaritah WA Ash Shatebi, Bab Sharqi, Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria Egypt Consultant
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data collected during this study will be available after deidentification Clinical Study Report,Informed Consent Form,Study Protocol Immediate. No end date Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 16/07/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 16/07/2024
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information