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.: PACTR202403633859291 Date of Approval: 13/03/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Evaluation of low dose Intrathecal Bupivacaine with dexmedetomidine
Official scientific title Evaluation of low dose Intrathecal Bupivacaine with dexmedetomidine in Geriatric Patients Undergoing Traumatic Hip Surgeries
Brief summary describing the background and objectives of the trial Proximal femoral fractures are common in geriatric population necessitating surgical fixation using Spinal anaesthesia. hypotension is common during spinal anaesthesia in elderly patients due to reduced physiological reserve and associated systemic diseases with increased risk of myocardial ischaemia secondary to hypotension. Hypotension caused by spinal anesthesia can be managed by administration of intravenous fluids and vasopressor agents which also carry risk of side effects in elderly. using low dose bupivacaine is associated with haemodynamic stability but it may not provide satisfied duration or level of anaesthesia required for hip surgery.This study will be conducted to evaluate and compare the efficacy of three different intrathecal dosages (10 mg, 12.5 mg and 15 mg) of 0.75% hyperbaric bupivacaine added with 5µg dexmedetomidine for traumatic hip surgery in elderly patients
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 01/02/2024
Actual trial start date 01/02/2024
Anticipated date of last follow up 01/05/2024
Actual Last follow-up date 01/09/2024
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 78
Recruitment status 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 Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group I 12.5 mg (2.5 ml) of 0.5 % hyperbaric bupivacaine + 5 μg dexmedetomidine single dose intrathecal injection patients will receive12.5mg (2.5 ml) of 0.5 % hyperbaric bupivacaine + 5 μg dexmedetomidine as intrathecal injection 26 Dose Comparison
Experimental Group Group II 10 mg (2 ml) of 0.5% hyperbaric bupivacaine +5 μg dexmedetomidine single intrathecal injection Patients received 10 mg (2ml) of 0.5% hyperbaric bupivacaine +5 μg dexmedetomidine as intrathecal injection 26
Experimental Group Group III 7.5 mg (1.5 ml) of 0.5 % hyperbaric bupivacaine +5 μg dexmedetomidine single dose intrathecal injection Patients received 7.5 mg (1.5 ml) of 0.5 % hyperbaric bupivacaine +5 μg dexmedetomidine as intrathecal injection 26
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
elderly patients (>65 years) either gender American Society of Anesthesiologists status I and II patients undergoing proximal femoral fractures fixation under spinal anesthesia age less than 65 years American Society of Anesthesiologists (ASA) physical status class III or more Contraindication to spinal anaesthesia: peripheral neuropathy coagulopathy spinal deformity infection at the injection site known hypersensitivity to bupivacaine or dexmedetomidine Aged: 65+ Year(s) 65 Year(s) 80 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 28/12/2023 Mansoura university faculty of medicine IRB
Ethics Committee Address
Street address City Postal code Country
Elgomhoria street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome time to 1st dose rescue analgesia 24 hs postoperative
Secondary Outcome sensory level block, two segment regression, hemodynamic stability and dose of vasopressors required intraoperative intraoperatively every 5 min in the 1st 30 min then 10 min till end of surgery
Secondary Outcome The total number of rescue analgesic doses required in 24 h postoperative, postoperative analgesia using numerical rating scale NRS, postoperative analgesic duration 24 h postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura University Emergency hospital algomhoria street mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
mansoura university elgomhoria street mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor mansoura university elgomhoria street mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherine Ali Elsayed Bakrey Ali Elsayed Bakrey sherinbakrey@mans.edu.eg 00201208703575 elgomhoria street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt Sherine A. Bakrey
Role Name Email Phone Street address
Scientific Enquiries Reem Abdelraouf Elsharkawy reemraouf64@gmail.com 00201006151100 elgomhoria street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Reem A Elsharkawy
Role Name Email Phone Street address
Public Enquiries Rania Elmohamady Elbadrawy raniaelmohamady@gmail.com 00201003689480 Elgomhoria street
City Postal code Country Position/Affiliation
mansoura 35516 Egypt Rania E Elbadrawy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified individual data that support the results will be shared beginning 9 months following publication provided the investigator who propose to use the data has approval from Institutional review board (IRB), Independent Ethics committee (IEC), or Research Ethics Board(REB) as applicable. Data sharing process will be available through contacting the following email : raniaelmohamady@gmail.com Informed Consent Form,Statistical Analysis Plan,Study Protocol within 12 months of completion of study controlled any researcher or organization covered by ethical commitee can have access to data after request of 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