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.: PACTR202304886237340 Date of Registration: 06/04/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Hemodynamic changes during intrathecal anesthesia with different Bupivacaine concentration in patients undergoing transurethral resection of prostate
Official scientific title Hemodynamic changes during intrathecal anesthesia with different Bupivacaine concentration in patients undergoing transurethral resection of prostate
Brief summary describing the background and objectives of the trial The incidence of benign prostatic hyperplasia is high(>60%) in men older than 60 years and increases up to 90% in men older than 80 years. The comorbidity rate is over 60% in elderly patients who undergo transurethral resection of the prostate (TURP), which directly affects perioperative morbidity and mortality .Spinal block is the most common anesthetic technique for TURP. It blocks up to the 10th thoracic dermatome [6]. As regards the pain pathway and differential spinal blockade pattern, sensory block up to T12 is adequate for TURP.The sensory block levels are 3–4 dermatomes higher in older age than in young adults . The sympatheticblock level is 1–4 segments higher than the analgesia level. Therefore, in elderly patients high sympathetic block is more frequent during spinal block, which explains the incidence of cardiovascular side effectscompared with young patients . The aim of the work is to compare haemodynamic changes during spinal anesthesia with different Bupivacaineconcentrations in elderly cardiac patients undergoingtransurethral resectionof prostate.
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 Early detection /Screening
Anticipated trial start date 05/04/2023
Actual trial start date 05/04/2023
Anticipated date of last follow up 05/10/2023
Actual Last follow-up date 05/10/2023
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants)
Recruitment status Active, not 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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group B during the whole procedure Patients will receive3 ml.of 0.5% bupivacaine.After confirming upper sensory block up to the T10 level 30 Active-Treatment of Control Group
Experimental Group Group A during the whole procedure Patients will receive 3 ml. of 0.25 % bupivacaine. After confirming upper sensory block up to the T10 level 30
Experimental Group Group C during the whole procedure patients will receive3 ml. of 0.375 % bupivacaine.After confirming upper sensory block up to the T10 level 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Age: more than 50 years old 2- with prostate surgerySex:male 3- (ASA): I-II 4- Operation: Prostate surgery -ASA :III-IV -Patient refusal -Contraindications to regional anesthesia bleeding tendency -Allergy to local anesthetics or opioids -lumber vertebra anomaly -Failed cases (failure of sensory level block) -Respiratory disorder -Morbid obese with comorbidities -Hepatic patient (bleeding disorder) Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 50 Year(s) 70 Year(s) Male
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 13/03/2023 Scientific Research Ethics Committee Kafrelsheikh university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El Geish street, Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Effect of subarachnoid block motor and sensory level time for block to T10 during the whole procedure
Secondary Outcome 1. Haemodynamics (BP , HR) hypotension decrease of blood pressure 30% from base line will be treated with 250 ml NS if no response ephedrine will be given , bradycardia HR below 50 B/min will be treated with atropine 0.5 mg. .Duration for motor block.2 3.Time for first dose of analgesia. 4.Opioid consumption. 5.Visual analogue scale (VAS) both relaxed and stressed for pain intensity ranged from 0 = no pain, up to 10 = the worse imaginable pain 6.Nausea and vomiting. 7.Pruritis (none ,mild ,moderate and severe) during the whole procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kafrelsheikh University Hospitals El geish street , Kafrelsheikh , Egypt Kafrelsheikh 33511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Sherif Kamal hafez Arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
Secondary Sponsor sherif kamal hafez arafa 12 tout Angh Amiun street Tanta 31527 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
sherif kamal hafez arafa 12 Tout Angh Amoun street Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries sherif arafa sherifarafa1020@gmail.com 00201005714014 12 Tout Angh Amiun street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Amir Abuzikary aabozikry@yahoo.com 00201016326544 23 Mohb street
City Postal code Country Position/Affiliation
Tanta 31527 Egypt assisstant professor of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results reported in article after deidentification (text, tables, figure and appendices) Study Protocol Beginning 9 months and ending 36 months following article publication Researchers who provide a methodologically sound proposal
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