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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202511738071134 Date of Registration: 21/11/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparison between Dexamedetomidine versus Labetalol for controlled Hypotensive Technique in Functional Endoscopic sinus Surgery : A randomized Controlled Trial
Official scientific title Comparison between Dexamedetomidine versus Labetalol for controlled Hypotensive Technique in Functional Endoscopic sinus Surgery : A randomized Controlled Trial
Brief summary describing the background and objectives of the trial Dexmedetomidine, a highly selective α₂-adrenoceptor agonist, is gaining popularity in controlled hypotensive techniques. It has sedative, anxiolytic, and analgesic properties and reduces sympathetic outflow and catecholamine release, resulting in decreased blood pressure and heart rate. It also provides a smoother recovery profile with minimal respiratory depression . Labetalol, a combined α₁- and non-selective β-adrenergic blocker, is traditionally used for rapid control of blood pressure. It decreases systemic vascular resistance via α₁ blockade and reduces heart rate and cardiac output via β blockade. However, it may cause bradycardia, and its titration can be less predictable compared to dexmedetomidine . This study investigates and compares these two agents in the context of controlled hypotension during FESS, aiming to identify which drug provides superior hemodynamic control, better surgical field conditions, and more favorable recovery characteristics the aim of the study To compare intravenous dexmedetomidine and labetalol for controlled hypotension during Functional Endoscopic sinus Surgery
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 01/11/2025
Actual trial start date
Anticipated date of last follow up 01/12/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 72
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 Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Labetalol Bolus: 0.25 mg/kg IV over 10 minutes before induction Infusion: 0.04 mg/kg/h IV until end of surgery once patients will recive Labetalo 36
Control Group Dexmedetomidine Bolus: 0.25 mg/kg IV over 10 minutes before induction Infusion: 0.04 mg/kg/h IV until end of surgery 2 hours patients will recive labetalol 36 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- ASA physical status I–II - Age 18 –65 years -male and female - Scheduled for elective FESS - Consent to participate ASA III or higher - Allergy to study drugs - Bradycardia, heart block, asthma - Chronic use of beta-blockers or α2-agonists - Coagulopathy or bleeding disorders -Acute decompensated heart failure - Peripheral vascular disease Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 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
No 01/11/2025 Institutional Review Board of Faculty of Medicine Assiut university
Ethics Committee Address
Street address City Postal code Country
Assiut university Asyut 71515 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hemodynamics SBP, MAP,HR every 10 min during intervention
Secondary Outcome Total blood loss (mL at end of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university hospitals Assiut university Asyut 71515 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Hany Galal Galal Assiut univeristy Asyut 71515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mohamed Hany Galal Galal Assiut university Asyut 71515 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Mohamed Hany Galal Galal Mohamed.17289660@med.aun.edu.eg +201001620542 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt Anesthesia ICU and pain mangement assiut university
Role Name Email Phone Street address
Principal Investigator Mohamed Mohamed Abdullahtif Mohamed.abdelatef@med.aun.edu.eg +201001745301 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt Anesthesia ICU and pain management assiut university
Role Name Email Phone Street address
Scientific Enquiries Ahmed Talat Ahmed Talaat83@aun.edu.eg +201062716629 Assiut university
City Postal code Country Position/Affiliation
Asyut 71515 Egypt Anesthesia ICU and pain management assiut university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data (IPD) underlying the results of this study will be made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes Informed Consent Form,Study Protocol 12 months after publication of results data will be available upon a reasonable request from the corresponding author.
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
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 16/11/2025 intervention using Labetalol Experimental Group, Dexmedetomidine, Bolus: 1 μg/kg IV over 10 minutes before induction Infusion: 0.5 μg/kg/h IV until end of surgery , once, patients will recive Dexmedetomidine, 36, Experimental Group, Labetalol, Bolus: 0.25 mg/kg IV over 10 minutes before induction Infusion: 0.04 mg/kg/h IV until end of surgery , once, patients will recive Labetalo, 36,
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD description 16/11/2025 IDP descreption The individual participant data (IPD) collected during this study will not be shared with other researchers or organizations because they contain potentially sensitive information and participants did not provide consent for data sharing. However, summary results of the study will be made publicly available within 12 months of study completion, in accordance with WHO requiremens De-identified individual participant data (IPD) underlying the results of this study will be made available to researchers upon reasonable request from the corresponding author after the publication of results, for a period of one year. The shared data will include anonymized variables relevant to the primary and secondary outcomes
Section Name Field Name Date Reason Old Value Updated Value
Reporting IPD-Sharing time frame 16/11/2025 time plan There is no plan to share individual participant data (IPD) at any time, as the dataset contains sensitive information and participants did not provide consent for data sharing 12 months after publication of results
Section Name Field Name Date Reason Old Value Updated Value
Reporting Key access criteria 16/11/2025 Who can access data Access to individual participant data will not be granted because the data contain sensitive information and participants did not consent to data sharing data will be available upon a reasonable request from the corresponding author.
Section Name Field Name Date Reason Old Value Updated Value
Reporting Study protocol document 16/11/2025 will share study protocol Informed Consent Form Study Protocol, Informed Consent Form