Clinical trial · Interventional
Opioid Free Anesthesia in Prolonged Surgery
Opioid-Free Anaesthesia During Prolonged Orthotopic Urinary Bladder Diversion Surgery: A Prospective Randomized Comparative Study.
- 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)
this study is designed to compare intrathecal bolus of bupivacaine-dexmedetomidine versus continuous epidural fentanyl infusion in providing effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery. The hypothesis Intrathecal bolus of bupivacaine-dexmedetomidine could replace continuous epidural fentanyl infusion and would be an enough intraoperative analgesic modality with good intraoperative hemodynamic stability and less postoperative complications in orthotopic urinary bladder diversion patients. Aim of the work The aim of this protocol is to document that intrathecal bolus of bupivacaine-dexmedetomidine analgesia (a low coast analgesic modality) can replace continuous epidural fentanyl infusion analgesic modality with effective operative analgesia, intraoperative hemodynamic stability and less postoperative cumulative opioid induced complications in orthotopic urinary bladder diversion prolonged surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Bladder | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| INTRATHECAL dexmedetomidine INJECTION | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Epidural Fentanyl group:
- description
- Epidural Fentanyl group: using an epidural catheter technique with epidural catheter set, and at L1-2 insertion level directed up to cover up to T6 sensory level, 5ml of bupivacaine 0.5%plus 50 micrograms fentanyl in a total volume of 40 ml added saline 0.9% (epidural injection of bolus of total Volume of 15 ml of 0.0625%bupivacaine with 1.25Mcg/ml fentanyl) then for next G anaesthesia hours to run in a 3-5 ml/h epidural infusion rate.
- type
- EXPERIMENTAL
- label
- Intrathecal dexmedetomidine group:
- description
- Intrathecal dexmedetomidine plus heavy bupivacaine then general A
- interventionNames
- Drug: INTRATHECAL dexmedetomidine INJECTION
Primary outcomes (1)
- measure
- Total postoperative ANALGESIC fentanyl DOSE
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients scheduled for orthotopic urinary bladder diversion prolonged surgery procedures. 2. American society of Anaethesiologists (ASA I-II). 3. Both sexes. 4. Age 18 - 70 years. Exclusion Criteria: 1. Patient refusal. 2. Hypersensitivity to amide local anesthetics or opioids as fentanyl. 3. General contraindications to spinal and epidural anaesthesia as thrombocytopenia, coagulopathy and severe dehydration. 4. Uncompensated Cardiac or hepatic patients. 5. Renal failure or respiratory failure patients.
References
Publications (0)
Data not yet available