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.: PACTR202301868522124 Date of Approval: 27/01/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of height based spinal anaesthesia dose versus conventional dose on haemodynamics in orthopaedic lower limb surgeries in geriatrics: A randomized controlled trial
Official scientific title Effect of height based spinal anaesthesia dose versus conventional dose on haemodynamics in orthopaedic lower limb surgeries in geriatrics: A randomized controlled trial
Brief summary describing the background and objectives of the trial Giving adequate dose of spinal anesthesia is of paramount value especially in geriatrics anesthesia. The aim of our study is to evaluate the effect of height-based dose of spinal anesthesia versus conventional dose of spinal anesthesia on intraoperative hemodynamics and spinal block charcteristics in geriatric patients undergoing lower limb orthopaedic surgeries. the study included 56 geriatric patients (aged 60 years or above) undergoing lower limb orthopaedic surgeries. They were divided into 2 groups. One group received conventional fixed dose consisted of 12.5 mg bupivacaine added to 25 micrograms fentanyl (in a total volume of 3 ml), while the other received height-based formula consisted of 0.06 mg of bupivacaine/cm height of the patient added to 25 micrograms fentanyl. The concentration of bupivacaine used in both groups was 0.5% hyperbaric bupivacaine while fentanyl concentration was 0.1 mg/2 ml.
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: Other
Anticipated trial start date 01/08/2020
Actual trial start date 01/08/2020
Anticipated date of last follow up 15/06/2021
Actual Last follow-up date 15/06/2021
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants) 56
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
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Height based spinal anaesthesia 5 minutes just before the surgery The patients received spinal anaesthesia consisting of hyperbaric bupivacaine 0.5% and fentanyl as the following:0.06 mg of bupivacaine per cm height of the patient with 25 microgram fentanyl (0.5 ml) 28
Control Group Conventional spinal anaesthesia 5 minutes just before the surgery The patients received spinal anaesthesia consisting of hyperbaric bupivacaine 0.5% and fentanyl as the following: 12.5 mg bupivacaine (2.5 ml) and 25 micrograms fentanyl (0.5 ml) in a total volume of 3 ml 28 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Geriatric population (60-year-old and over) ASA class I or II Undergoing lower limb orthopaedic surgeries under spinal anaesthesia Contraindications to spinal anaesthesia e.g., patient refusal, infection at the site of spinal anaesthesia, sepsis, hypovolaemia, coagulopathy, indeterminate neurologic disease, increased intracranial pressure and autonomic neuropathy Patient refusal Short stature less than 150 cm History of allergy to medications used and opioid abuse Risk factors affecting blood pressure after spinal anaesthesia such as uncontrolled hypertension, chronic alcohol abuse, and major cardiac, renal or hepatic dysfunction 80 and over: 80+ Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 60 Year(s) 85 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 28/06/2020 Research Ethics Committee Faculty of Medicine Cairo University
Ethics Committee Address
Street address City Postal code Country
Kasr Alainy street Cairo 11562 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hypotension (20% decrease in systolic blood pressure from baseline readings Baseline, then at 3-minute intervals during the first 20 minutes, then at 5-minute intervals until the end of surgery
Secondary Outcome Bradycardia (heart rate less than 50 beat/minute) Baseline, then at 3-minute intervals during the first 20 minutes, then at 5-minute intervals until the end of surgery
Secondary Outcome Highest sensory level and onset of sensory block Using a pinprick test every minute after the end of injection
Secondary Outcome Duration of sensory block and time to first analgesic request Using a pinprick test every 15 min after the end of the surgery
Secondary Outcome Onset of motor block Assessment of the Bromage Scale every 2 min till reaching grade 3 before the surgery
Secondary Outcome Duration of motor block Assessment of the Bromage Scale every 15 min till reaching grade 0 after the surgery
Secondary Outcome Intraoperative shivering Throughout the surgery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University Hospitals Kasr Alainy Street Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ramy Alkonaiesy Kasr Alainy Street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cairo University Hospitals Kasr Alainy Street Cairo Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Shereen Amin res.train.1111@gmail.com +201224883990 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Public Enquiries Ramy Alkonaiesy ramy.alkonaiesy13@gmail.com +201224883990 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
Role Name Email Phone Street address
Scientific Enquiries Ramy Alkonaiesy ramy.alkonaiesy13@gmail.com +201224883990 Kasr Alainy Street
City Postal code Country Position/Affiliation
Cairo Egypt Department of Anesthesia Surgical ICU and Pain Management Faculty of Medicine Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the individual de-identified participants’ data. The datasets generated and/or analyzed during the current study will be available from the corresponding author on reasonable request, beginning 12 months and ending 24 months following article publication. Study Protocol Beginning 12 months and ending 24 months following article publication. Data will be available on reasonable request from the corresponding author to be used for systematic reviews or meta-analyses.
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