Clinical trial · Interventional
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
NCT07276867CI-TRIAL-00098808recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The current work evaluated whether the combination of intrathecal dexmedetomidine and fentanyl provides superior postoperative analgesia to fentanyl alone when administered with hyperbaric bupivacaine.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Above Knee Amputation | — | UNRESOLVED | — |
| Bupivacaine | — | UNRESOLVED | — |
| Dexmedetomidine | — | UNRESOLVED | — |
| Fentanyl | — | UNRESOLVED | — |
| Intrathecal | — | UNRESOLVED | — |
| Lower Extremity | — | UNRESOLVED | — |
| Sarcomas | Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Spinal Anesthesia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fentanyl | Drug | — | UNRESOLVED |
| Fentanyl + Dexmedetomidine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group DF
- description
- Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl + 5 µg dexmedetomidine.
- interventionNames
- Drug: Fentanyl + Dexmedetomidine
- type
- ACTIVE_COMPARATOR
- label
- Group F
- description
- Patients will receive 2.5 mL of 0.5% hyperbaric bupivacaine with 25 µg fentanyl.
- interventionNames
- Drug: Fentanyl
Primary outcomes (1)
- measure
- Time to first rescue analgesia
- timeFrame
- 24 hours postoperatively
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Age from 18 to 60 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status of II-III. * Height between 150-185 cm. * Body mass index between 18-35 kg/m². * Scheduled for above-knee amputation due to lower limb sarcomas. Exclusion Criteria: * Allergy to any of the investigated drugs. * History of heart block, arrhythmia, or ongoing therapy with beta- or calcium channel- blockers, or angiotensin-converting-enzyme inhibitors. * Contraindications to spinal anesthesia. * Pregnancy or lactation. * Presence of psychiatric illness or chronic pain conditions.
References
Publications (0)
Data not yet available
No reference posted for this study.