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.: PACTR202509618978504 Date of Registration: 02/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of dexmedetomidine on optic nerve sheath diameter during abdominal aortic aneurysm repair.
Official scientific title Impact of dexmedetomidine on sonographic optic nerve sheath diameter during abdominal aortic aneurysm repair: A randomized controlled trial.
Brief summary describing the background and objectives of the trial Abdominal aortic aneurysm (AAA) repair is a high-risk surgical procedure associated with significant hemodynamic changes, blood loss, and potential neurological complications due to perioperative hypotension or embolic events.Spinal cord ischemia (SCI) is a rare but major complication following AAA repair, particularly after extensive open surgical or endovascular procedures The optic nerve sheath diameter (ONSD), as measured by bedside ultrasonography, has emerged as a non-invasive, rapid and reliable surrogate marker for elevated ICP in various clinical settings. An increase in ONSD may reflect elevated intracranial pressure or altered cerebrospinal fluid dynamics, both of which may parallel changes in spinal cord perfusion. study aimed to show the effect of Dexmedetomidine infusion on the spinal cord ischemia occur during the repair of Abdominal Aortic Aneurysm during the clamping stage by assesing the effect of dexmedetomidine on sonographic optic nerve sheath diameter (ONSD) as a non-invasive indicator of intracranial pressure during elective abdominal aortic aneurysm (AAA) repair.
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 Diagnosis / Prognosis
Anticipated trial start date 01/09/2025
Actual trial start date
Anticipated date of last follow up 01/03/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 50
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
Control Group Group C placebo infusion patients will receive normal saline 10 minutes before induction of anaesthesia and until completion of the surgery. Patients will receive 200 ml of normal saline 10 minutes before induction and followed by continuous infusion of normal saline .9% using a syringe pump (50ml placebo syringe) until the completion of the operation. 25 Placebo
Experimental Group Group D dexmetomedine infusion 0.5 µgm./kg dexmedetomedine 10 minutes before induction till the end of surgery Patients will receive 0.5 µgm./kg Dexmedetomidine in 200 ml of normal saline 10 minutes before induction and followed by continuous infusion at a dose of 0.5 µgm/kg/hr using a syring pump (50ml syringe with 4 µgm dex.\ml). until the completion of the operation. 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients aged from 30 to 65 years old. 2. Patients had a body mass index less than 30 kg/m2. 3. Patients had conditions classified as І and ІІ according to the American Society of Anesthesiologists. 4. Patients suffered from abdominal aortic aneurysms. 1. Patient’s refusal. 2. Patients who had eye diseases, central nervous system diseases, cardiovascular diseases and or diabetes. 3. Patients whose ultrasound scans or measurements failed to clearly show the structure of optic nerve sheath diameter. 4. Patients whose surgical time was less than 1 hour. 5. Patients had a history of allergy to α2 agonists. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 30 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 25/08/2025 mansoura university IRB
Ethics Committee Address
Street address City Postal code Country
IRB office-ground floor-building A - faculty of medicine-mansoura university mansoura 35511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome sonographic optic nerve sheath diameter (ONSD) as a non-invasive indicator of intracranial pressure during elective abdominal aortic aneurysm (AAA) repair. 10 minutes before the induction of anesthesia , 5 minutes after induction, after 30 minutes, immediate before clamping, at the time of clamping, after removal of clamping, at the end of surgery.
Secondary Outcome MAP, HR and oxygen saturation 10 minutes before the induction of anesthesia , 5 minutes after induction, after 30 minutes, immediate before clamping, at the time of clamping, after removal of clamping, at the end of surgery.
Secondary Outcome Postoperative complication as postoperative dizziness, nausea, vomiting headache within 3 hours following surgery.
Secondary Outcome The time to awakening the duration between the completion of surgery and the occurrence of eye-opening spontaneously or in response to a spoken order or according to Ricker sedation-agitation scale. the duration between the completion of surgery and the occurrence of eye-opening spontaneously or in response to a spoken order or according to Ricker sedation-agitation scale.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university hospitals gomhoreia street , mansoura , egypt mansoura 35511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mohamed nashaat alkha ,mansoura mansoura 35511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university talkha, mansoura mansoura 35511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohammed mohammed Moh_nashaat@mans.edu.eg 00201092323198 talka, mansoura , egypt
City Postal code Country Position/Affiliation
mansoura 35511 Egypt assistant professor
Role Name Email Phone Street address
Public Enquiries Maha Younis Youssef Abdallh nashaatbaraka1@gmail.com 00966592308487 elgomhoria street, mansoura
City Postal code Country Position/Affiliation
mansoura 35511 Egypt assistant professor
Role Name Email Phone Street address
Scientific Enquiries mohammed mohammed Moh_nashaat@mans.edu.eg 00201092323198 talkha , mansoura
City Postal code Country Position/Affiliation
mansoura Egypt assistant professort
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication open access
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
Trial Information Trial description 29/08/2025 According to the reviewer demand This study aimed to show the effect of Dexmedetomidine infusion on the spinal cord ischemia occur during the repair of Abdominal Aortic Aneurysm during the clamping stage by assesing the effect of dexmedetomidine on sonographic optic nerve sheath diameter (ONSD) as a non-invasive indicator of intracranial pressure during elective abdominal aortic aneurysm (AAA) repair. Abdominal aortic aneurysm (AAA) repair is a high-risk surgical procedure associated with significant hemodynamic changes, blood loss, and potential neurological complications due to perioperative hypotension or embolic events.Spinal cord ischemia (SCI) is a rare but major complication following AAA repair, particularly after extensive open surgical or endovascular procedures The optic nerve sheath diameter (ONSD), as measured by bedside ultrasonography, has emerged as a non-invasive, rapid and reliable surrogate marker for elevated ICP in various clinical settings. An increase in ONSD may reflect elevated intracranial pressure or altered cerebrospinal fluid dynamics, both of which may parallel changes in spinal cord perfusion. study aimed to show the effect of Dexmedetomidine infusion on the spinal cord ischemia occur during the repair of Abdominal Aortic Aneurysm during the clamping stage by assesing the effect of dexmedetomidine on sonographic optic nerve sheath diameter (ONSD) as a non-invasive indicator of intracranial pressure during elective abdominal aortic aneurysm (AAA) repair.
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 29/08/2025 modified according to the reviewer Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s) Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/08/2025 add name of intervention Control Group, Group C , patients will receive normal saline, 10 minutes before induction of anaesthesia and until completion of the surgery., Patients will receive 200 ml of normal saline 10 minutes before induction and followed by continuous infusion of normal saline .9% using a syringe pump (50ml placebo syringe) until the completion of the operation., 25, Placebo Control Group, Group C placebo infusion , patients will receive normal saline, 10 minutes before induction of anaesthesia and until completion of the surgery., Patients will receive 200 ml of normal saline 10 minutes before induction and followed by continuous infusion of normal saline .9% using a syringe pump (50ml placebo syringe) until the completion of the operation., 25, Placebo
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/08/2025 add intervention name Experimental Group, Group D, 0.5 µgm./kg dexmedetomedine, 10 minutes before induction till the end of surgery, Patients will receive 0.5 µgm./kg Dexmedetomidine in 200 ml of normal saline 10 minutes before induction and followed by continuous infusion at a dose of 0.5 µgm/kg/hr using a syring pump (50ml syringe with 4 µgm dex.\ml). until the completion of the operation., 25, Experimental Group, Group D dexmetomedine infusion, 0.5 µgm./kg dexmedetomedine, 10 minutes before induction till the end of surgery, Patients will receive 0.5 µgm./kg Dexmedetomidine in 200 ml of normal saline 10 minutes before induction and followed by continuous infusion at a dose of 0.5 µgm/kg/hr using a syring pump (50ml syringe with 4 µgm dex.\ml). until the completion of the operation., 25,