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Opioid Free Anesthesia in Prolonged Surgery

Primary Purpose

Cancer, Bladder

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
INTRATHECAL dexmedetomidine INJECTION
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer, Bladder focused on measuring Opioid-Free Anaesthesia, Prolonged Orthotopic Urinary Bladder Diversion Surgery, Intrathecal dexmedetomidine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Epidural Fentanyl group:

Intrathecal dexmedetomidine group:

Arm 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.

Intrathecal dexmedetomidine plus heavy bupivacaine then general A

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 4, 2022
Last Updated
March 1, 2022
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05262166
Brief Title
Opioid Free Anesthesia in Prolonged Surgery
Official Title
Opioid-Free Anaesthesia During Prolonged Orthotopic Urinary Bladder Diversion Surgery: A Prospective Randomized Comparative Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 10, 2022 (Anticipated)
Primary Completion Date
August 10, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
Opioid-free anaesthesia is becoming a popular technique among clinicians. The technique involves administering anaesthesia without any intraoperative systemic, neuraxial or intracavitary opioid It helps in avoiding the opioids during the perioperative period. Opioid-free anaesthesia can be performed along with loco-regional analgesia for better pain control, though it is not always mandatory Spinal bupivacaine-dexmedetomidine can produce intraoperative prolonged continuous analgesia in abdominal surgeries. On the other hand, the stability of continuous epidural fentanyl infusion would produce hemodynamic stability with effective analgesia in orthotopic urinary bladder diversion as an analgesia technique during prolonged abdominal surgery free of nephrotoxic drugs such as NSAIDs. Lipophilic opioids such as fentanyl remain longer within the epidural space by partitioning into epidural fat and thus are found in lower concentrations in cerebrospinal fluid compared with hydrophilic opioids such as morphine. During prolonged infusion of lipophilic opioids such as fentanyl and sufentanyl, the plasma concentration and analgesic effect of these drugs are similar to that of an intravenous infusion . Titration of epidural local anesthetic and opioid concentrations must be performed to attain a balance between providing optimal analgesia and avoiding hemodynamic instability. The addition of fentanyl does not prolong the sensory and motor block characteristics of dexmedetomidine . Intrathecal dexmedetomidine is superior to intrathecal magnesium sulfate (MgSO4) during caesarean section with regard to duration of analgesia, pain severity and stress hormone levels. Dexmedetomidine has a rapid onset and longer duration of sensory block compared to MgSO4 . Paramasivan and his colleagues documented that intrathecal dexmedetomidine has prolonged postoperative analgesic duration, reduced 24 hours pain intensity and reduced the incidence of shivering without an increase in other adverse effects compared to placebo . Using dexmedetomidine as an adjuvant to bupivacaine for spinal anesthesia in lower limb surgeries has longer duration of sensory and motor block and longer postoperative analgesia . Mazy and his colleagues documented that intrathecal dexmedetomidine 10 micrograms (mic) and bupivacaine 20 milligram with or without fentanyl 25 mic were suitable for long orthopedic procedures within 6 hours duration. The addition of fentanyl does not prolong the sensory and motor block characteristics of dexmedetomidine. In favor of dexmedetomidine-fentanyl combination was the less hypotension and less sedative requirement . Epidural fentanyl administered by a continuous infusion can provide an efficient postoperative analgesia and is responsible for a moderate ventilatory depression . Patel Nagar and his colleagues documented that intrathecal dexmedetomidine of 10 micrograms when compared to lower doses as an adjuvant to hyperbaric bupivacaine significantly prolongs the duration of sensory block, motor block, and analgesia. A disproportionate increase in the duration of analgesia and motor block produces both clinically and statistically significant prolongation of the duration of differential analgesia. Addition of 10 micrograms of intrathecal dexmedetomidine is associated with fewer requirements of postoperative analgesics in patients undergoing lower abdominal and lower limb surgeries without any significant increase in the incidence of side effects .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Bladder
Keywords
Opioid-Free Anaesthesia, Prolonged Orthotopic Urinary Bladder Diversion Surgery, Intrathecal dexmedetomidine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural Fentanyl group:
Arm Type
No Intervention
Arm 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.
Arm Title
Intrathecal dexmedetomidine group:
Arm Type
Experimental
Arm Description
Intrathecal dexmedetomidine plus heavy bupivacaine then general A
Intervention Type
Drug
Intervention Name(s)
INTRATHECAL dexmedetomidine INJECTION
Intervention Description
intrathecal bolus of 3ml bupivacaine 0.5% (15mg) plus 10 micrograms dexmedetomidine at 2-3 or 3-4 spinal level.
Primary Outcome Measure Information:
Title
Total postoperative ANALGESIC fentanyl DOSE
Description
Total postoperative intravenous fentanyl requirements in the first twinty four hours after spinal dexmedetomedine
Time Frame
first 24 hours in both groups.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled for orthotopic urinary bladder diversion prolonged surgery procedures. American society of Anaethesiologists (ASA I-II). Both sexes. Age 18 - 70 years. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MOHAMED A GHANEM
Phone
01067883998
Email
MOHAMED.ABDEL_LATIF@YAHOO.COM
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MOHAMED GHANEM, professor
Organizational Affiliation
Urology Nephrology center, Faculty of Medicine, Mansoura Univeristy
Official's Role
Study Director
Facility Information:
Facility Name
Medicine
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35931
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
mohamed A ghanem, professor
Phone
01067883998
Email
mohamed.abdel_latif@yahoo.com

12. IPD Sharing Statement

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Opioid Free Anesthesia in Prolonged Surgery

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