A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine.
Rajni Gupta, Reetu Verma, Jaishri Bogra...
https://pubmed.ncbi.nlm.nih.gov/21897504Actively Recruiting
Phase 4
Age: 20Years - 60Years
All Genders
ID07078201
Comparative Analysis of Intraoperative Effect of Dexmedetomidine and Fentanyl as Adjuvants to Heavy Bupivacaine in Spinal Anesthesia for Lower Limb Orthopedic Surgeries
Led by Nashwa Ahmed · Updated on 2025-12-30
40
Participants Needed
1
Research Sites
23 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of adding dexmedetomidine or fentanyl to heavy bupivacaine spinal anesthesia in patients undergoing elective lower limb orthopedic surgeries. This study aims to compare the hemodynamic stability, onset, and duration of motor block with these adjuvants, addressing the current limitation of short action duration of local anesthetics. Both drugs are studied for their potential to enhance analgesia while monitoring possible side effects. Participants are randomly assigned to receive either 4 µg dexmedetomidine or 25 µg fentanyl added to 3 mL of 0.5% hyperbaric bupivacaine via intrathecal injection. The anesthesia is administered after standard preloading and under strict aseptic technique, with continuous monitoring of vital signs including blood pressure and heart rate during surgery. The study includes detailed assessments of motor block onset and duration using the Modified Bromage scale, with treatment adjustments for any complications such as hypotension or bradycardia. During the study, participants undergo baseline clinical evaluation and continuous intraoperative monitoring of vital signs every 15 to 30 minutes over approximately 90 minutes. Researchers document the time to full motor block and its resolution, as well as any intraoperative complications like nausea, vomiting, or respiratory depression. The primary outcomes focus on motor block duration and onset, along with heart rate and blood pressure stability, all assessed within specific time frames. The total participation period aligns with the surgery and immediate recovery phase, emphasizing safety and efficacy monitoring.
CONDITIONS
Brief Title
Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries to Evaluate the Hemodynamic Stability and Onset and Duration of Motor Block of Using Intrathecal Dexmedetomidine and Fentanyl
Who Can Participate
Age: 20Years - 60Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 20 and 60 years
- American Society of Anaesthesiologists (ASA) physical status 1 or 2
- Scheduled for elective lower limb orthopedic surgery
- Height between 150 and 180 cm
- Weight between 50 and 70 kg
- Any gender (male or female)
You will not qualify if you...
- Patient refusal to participate
- Absolute contraindication to spinal anesthesia
- Neurological disorders, pregnancy, or local infection at the injection site
- Dysrhythmia or heart block
- ASA physical status 3 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 90 minutes during surgery
Participants receive spinal anesthesia with either dexmedetomidine or fentanyl as an adjuvant to heavy bupivacaine during lower limb orthopedic surgery. Intraoperative monitoring of vital signs and motor block is performed.
1 in-person surgery and monitoring visit
Trial Site Locations
Total: 1 location
1
Port said university
Port Said, Egypt, 42111
Actively Recruiting
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Research Team
N
Nashwa gomaa Ahmed, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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Published Research Related To This Trial
The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section.
Sameh Abdelkhalik Ahmed, Hashem Adel Lotfy, Tarek Abdel Hay Mostafa
https://pubmed.ncbi.nlm.nih.gov/38666154A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo.
Subodh Kumar, Biswadeep Choudhury, Seshadri R Varikasuvu...
https://pubmed.ncbi.nlm.nih.gov/36644042