Opioid Free Anesthesia in Prolonged Surgery

NCT05262166 | Unknown

• 1 other identifier: MS.21.10.1699(date 21/11/2021)
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cancer, Bladder

Keywords

Opioid-Free Anaesthesia; Prolonged Orthotopic Urinary Bladder Diversion Surgery; Intrathecal dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Total postoperative ANALGESIC fentanyl DOSE

  Total postoperative intravenous fentanyl requirements in the first twinty four hours after spinal dexmedetomedine

  first 24 hours in both groups.

Study Arms (2)

Epidural Fentanyl group:

NO INTERVENTION

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.

Intrathecal dexmedetomidine group:

EXPERIMENTAL

Intrathecal dexmedetomidine plus heavy bupivacaine then general A

Drug: INTRATHECAL dexmedetomidine INJECTION

Interventions

INTRATHECAL dexmedetomidine INJECTION DRUG

intrathecal bolus of 3ml bupivacaine 0.5% (15mg) plus 10 micrograms dexmedetomidine at 2-3 or 3-4 spinal level.

Intrathecal dexmedetomidine group:

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for orthotopic urinary bladder diversion prolonged surgery procedures.
• American society of Anaethesiologists (ASA I-II).
• Both sexes.
• Age 18 - 70 years.

You may not qualify if:

• Patient refusal.
• Hypersensitivity to amide local anesthetics or opioids as fentanyl.
• General contraindications to spinal and epidural anaesthesia as thrombocytopenia, coagulopathy and severe dehydration.
• Uncompensated Cardiac or hepatic patients.
• Renal failure or respiratory failure patients.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Medicine

Al Mansurah, Dakahlia Governorate, 35931, Egypt

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• MOHAMED GHANEM, professor

  Urology Nephrology center, Faculty of Medicine, Mansoura Univeristy

  STUDY DIRECTOR

Central Study Contacts

MOHAMED A GHANEM

CONTACT

01067883998; MOHAMED.ABDEL_LATIF@YAHOO.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 2, 2022
• Study Start: March 10, 2022
• Primary Completion: August 10, 2022
• Study Completion: August 15, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-03

Locations

EG (1)