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.: PACTR202311786558285 Date of Approval: 14/11/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The preoperative oral caffeine for the prophylaxis against spinal anesthesia induced hypotension in patients undergoing orthopedic lower limb surgery: A randomized controlled study
Official scientific title The preoperative oral caffeine for the prophylaxis against spinal anesthesia induced hypotension in patients undergoing orthopedic lower limb surgery: A randomized controlled study
Brief summary describing the background and objectives of the trial Following spinal anesthesia, hypotension results mainly from a decrease in systemic vascular resistance secondary to a blockage of sympathetic fibers and an increase in vagal tone. Thus, therapeutic strategies that can reduce the risk of hypotension after spinal anesthesia may prevent more critical side effects related to this technique. The effect of caffeine consumption was observed at single doses of caffeine ranging from 80 to 300 mg, inducing a mean increase in systolic BP of about 3–8 mmHg and in diastolic BP of about 4–6 mmHg, with high inter-individual variability. The objective of this study is to evaluate the the effect of oral caffeine given before surgery in adult patients undergoing lower extremity orthopedic surgery on the incidence of spinal anesthesia induced hypotension.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Orthopaedics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 10/12/2023
Actual trial start date 10/12/2023
Anticipated date of last follow up 01/06/2024
Actual Last follow-up date 01/07/2024
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
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 Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Placebo will be received single preoperative dose Just before surgery single preoperative dose will be received before surgery 40 Placebo
Experimental Group caffeine group Patients in caffeine group will receive a single dose of caffeine 200 mg tablet, 60 minutes before spinal anesthesia with small amount of clear water. before spinal anesthesia Patients in caffeine group will receive a single dose of caffeine 200 mg tablet, 30 minutes before spinal anesthesia with small amount of clear water. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1- Patients of both sexes aged 18 to 70 undergoing lower limb orthopedic surgery using spinal anesthesia. 2- Height from 160 cm to 180 cm. 3- American Society of Anesthesiologist physical status I, II or III. 1. Patients who refuse to participate in the study 2. Elevated BP (>160/100 mm Hg) 3. Failed spinal anesthesia 4. Patients with known cardiovascular disease 5. Patients with known cerebrovascular disease 6. Patients with known neurological, neurodegenerative or psychiatric disease 7. Patients with known liver failure 8. Clinical history of diabetes 9. Contraindication to spinal anaesthesia e.g. coagulopathy, H 10. Patients with known caffeine or coffee allergy Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 70 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 01/11/2023 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome to investigate the efficacy of prophylactic preoperative caffeine in preventing spinal anesthesia-induced hypotension Hemodynamic data will be serially recorded at 5, 10,15, 20 30, 45,60, 90, and 120 minutes after baseline.
Secondary Outcome the total amounts of rescue ephedrine and atropine and the incidences of nausea/vomiting requiring treatment between the groups. The incidence of post dural puncture headache and postoperative delirium will be recorded. Hemodynamic data will be serially recorded at 3, 5, 10, 30, 60, 90, and 120 minutes after baseline.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ibrahim Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Abdelbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abdelbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Public Enquiries Sohila Samir Sohilaantar@gmail.com +201012282007 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Resident of anesthesia Mansoura University Hospital
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Hassan Drmahmmoudhassan@mans.edu.eg +201006192325 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual data will be available (including data dictionaries). All of the individual participant data collected during the trial, after de-identification. Study protocol and informed consent form will be available Data will be available: - Immediately following publication with no end date. - For anyone who wishes to access the data - For any type (purpose) of analyses - Upon proposal(s) that should be directed to Sohilaantar@gmail.com. Informed Consent Form,Study Protocol Immediately following publication. No end date. Proposals should be directed to Sohilaantar@gmail.com. Open access will be permitted to get the data please send an e-mail to Sohilaantar@gmail.com (public relations). Researchers decided to send data when requested. No quality of request is required.
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