RecruitingNot ApplicableNCT07276867

Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity

Intrathecal Dexmedetomidine-Fentanyl Combination Versus Fentanyl Alone as Adjuvant to Bupivacaine in Spinal Anesthesia for Above Knee Amputation in Sarcomas of Lower Extremity: A Randomized, Comparative Study


Sponsor

National Cancer Institute, Egypt

Enrollment

58 participants

Start Date

Oct 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two types of spinal anesthesia (numbing medicine injected into the spine) for people undergoing above-the-knee leg amputation due to bone or soft tissue cancer. One approach uses fentanyl alone, and the other combines fentanyl with dexmedetomidine, to see which provides better pain control. **You may be eligible if...** - You are 18–60 years old - You are scheduled for above-knee leg amputation due to a sarcoma (bone or soft tissue cancer) - Your height is between 150–185 cm and your BMI is 18–35 - You are classified as ASA II or III (moderate underlying health conditions) **You may NOT be eligible if...** - You have a known allergy to any of the study medications - You have a heart rhythm problem, heart block, or are on certain heart medications (beta-blockers, calcium channel blockers, ACE inhibitors) - You have a condition that makes spinal anesthesia unsafe - You are pregnant or breastfeeding - You have a psychiatric illness or chronic pain condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFentanyl + Dexmedetomidine

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.

DRUGFentanyl

Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.


Locations(1)

National Cancer Institute

Cairo, Egypt

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NCT07276867


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