The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial
Phase: PHASE4
Conditions: Hemodynamics, Pain, ASA I-II Requiring Simple Dental Extraction of a Mandibular Tooth
Sponsor: King Abdulaziz University

The Effect of Different Vasoconstrictive Agents on Hemodynamics Among Patients 
Undergoing Simple Mandibular Exodontia: A Triple-Blind Randomized Controlled Trial 
Study Protocol and Statistical Analysis Plan 
ClinicalTrials.gov Identifier (NCT Number): NCT240-11-23 
Document Date: June 2, 2025 
Institution: 
King Abdulaziz University Faculty of Dentistry (KAUFD) 
Jeddah, Saudi Arabia 
Principal Investigator: 
Dr. Razan Baabdullah 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
Background and Rationale: 
Epinephrine is widely used as a vasoconstrictor in dental local anesthetics; however, epinephrine 
bitartrate has been suggested as a potential alternative. The comparative hemodynamic effects 
and analgesic efficacy of these agents remain underexplored. 
Objectives: 
Primary: To compare the effects of 1:100,000 epinephrine and 1:55,000 epinephrine bitartrate on 
blood pressure and heart rate during simple mandibular exodontia. 
Secondary: To assess the analgesic duration of the two agents using Visual Analogue Scale 
(VAS) scores. 
Study Design: 
Triple-blind, randomized controlled trial conducted at King Abdulaziz University Dental 
Hospital from December 2023 to April 2024. 
Participants: 
Inclusion: Adults ≥18 years, ASA I or II, requiring simple mandibular tooth extraction. 
Exclusion: Pregnancy, ASA III or higher, systemic disease, anticoagulant use, psychiatric illness, 
allergies to anesthetics, and surgical extractions. 
Sample Size Calculation: 
Using G*Power software with an effect size of 0.75, α = 0.05, and power = 80%, a total of 52 
participants (26 per group) were targeted, accounting for potential dropouts. 
Randomization and Blinding: 
Simple randomization by an independent statistician. Allocation concealed. Blinding maintained 
for patients, operators, and data assessors. 
Intervention: 
Group A: 2% mepivacaine with 1:100,000 epinephrine. 
Group B: 2% mepivacaine with 1:55,000 epinephrine bitartrate. 
Max 2 cartridges administered per procedure. 
Data Collection: 
Demographics, medical history, operator level, tooth type, and procedural duration. 
Hemodynamic parameters measured pre-op, intra-op (3 mins post-injection), and post-op. Pain 
scores measured via VAS every 30 minutes. 
Outcome Measures: 
• 
Primary: Systolic/diastolic blood pressure, heart rate. 
• 
Secondary: Pain score using VAS. 
 

Statistical Analysis Plan 
Software: 
Stata 12.2 (StataCorp LP, College Station, Texas, USA) 
Descriptive Statistics: 
Means and SDs for continuous variables; frequencies and percentages for categorical variables. 
Inferential Statistics: 
• 
Normality assessed by histogram, skewness, and kurtosis. 
• 
Between-group comparisons using two-sample t-test or Wilcoxon Rank Sum test 
depending on normality. 
• 
Primary outcomes analyzed as difference in BP and HR across time points. 
• 
VAS scores analyzed for intra- and post-operative differences. 
Significance Threshold: 
p-value ≤ 0.05 considered statistically significant. 
Analysis Type: 
Intention-to-treat. 
Handling of Missing Data: 
No missing data anticipated. All randomized patients included in analysis unless protocol 
deviation occurred (e.g., anesthetic failure). 
Ethical Considerations: 
IRB approval obtained (Reference: 240-11-23). Informed consent obtained from all participants. 
Confidentiality ensured.