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Clinical Trials in Egypt / NCT07078201
Recruiting Phase 4

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

NCT07078201 · tracked via the Priya Life Science Egypt tracker
Sponsor
Nashwa Ahmed
Phase
Phase 4
Started
2025-07-01
Last updated
2025-12-30

Condition(s) studied

Spinal Anesthesia Duration

Investigational drug(s) / intervention(s)

Dexmedetomidine →fentanyl →

Dexmedetomidine: patients received 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn).

fentanyl: patients received 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.

Study summary

Spinal anesthesia is the most widely employed procedure for lower limb orthopedic operations, as it is very cost-effective and simple to apply. These advantages could be restricted because presently existing local anesthetic drugs had relatively short length of action. (1) Spinal anesthesia with 0.5% heavy bupivacaine (hyperbaric) is a common technique, still there was burden of its short duration of action. To overcome this issue, there was a continuous search for an ideal adjuvant.(2) Adjuvants were mostly added to local anesthetic drugs to increase their effectiveness, speedy onset, increase the period of the block, and reduce the local anesthetics dosage, thus reduction their adverse effects.(3) Such adjuvants had been beneficial in extension of analgesia along with initiation of movement though their related side effects.(4)

Eligibility

Sex
ALL
Min age
20 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. The patient aged range from 20 to 60 years 2. ASA 1 and 2 3. Patient prepared for elective lower limb orthopaedic surgeries. 4. Height 150-180 cm. 5. Weight 50-70 kg. 6- Either sex male or female. Exclusion Criteria: \- 1- Patient refusal. 2- Patient had absolute contraindication to spinal anaesthesia. 3-Patients with neurological disorders, pregnancy, local infection at the site of injection. 4- Patients suffering from dysrhythmia or heart block. 5- Patients with ASA 3 or more.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Port said university Port Said Egypt Recruiting

More Nashwa Ahmed trials in Egypt

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07078201 on ClinicalTrials.gov ↗ ← All trials in Egypt