RecruitingPhase 4NCT07078201

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

Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries.


Sponsor

Nashwa Ahmed

Enrollment

40 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 YearsMax Age: 60 Years

Inclusion Criteria5

  • The patient aged range from 20 to 60 years
  • ASA 1 and 2
  • Patient prepared for elective lower limb orthopaedic surgeries.
  • Height 150-180 cm.
  • Weight 50-70 kg. 6- Either sex male or female.

Exclusion Criteria2

  • \- 1- Patient refusal. 2- Patient had absolute contraindication to spinal anaesthesia. 3-Patients with neurological disorders, pregnancy, local infection at the site of injection.
  • Patients suffering from dysrhythmia or heart block. 5- Patients with ASA 3 or more.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGDexmedetomidine

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saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn).

DRUGfentanyl

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


Locations(1)

Port said university

Port Said, Egypt

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07078201


Related Trials