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Cancer, BladderNCT05262166

Opioid Free Anesthesia in Prolonged Surgery

A study testing INTRATHECAL dexmedetomidine INJECTION in people with Cancer, Bladder, run by Mansoura University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Cancer, Bladder
What is being tested?
INTRATHECAL dexmedetomidine INJECTION
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteEgypt
Study dates
10 Mar 2022to 15 Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Medicine

    Al Mansurah, Dakahlia Governorate, 35931

    mohamed A ghanem, professor, 01067883998, mohamed.abdel_latif@yahoo.com

Other trials in Egypt

About this study

Official title: Opioid-Free Anaesthesia During Prolonged Orthotopic Urinary Bladder Diversion Surgery: A Prospective Randomized Comparative Study.

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.

Read the 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 .

Conditions
Cancer, Bladder
Being tested
INTRATHECAL dexmedetomidine INJECTION
Keywords
Opioid-Free Anaesthesia, Prolonged Orthotopic Urinary Bladder Diversion Surgery, Intrathecal dexmedetomidine
Medical subject headings
Urinary Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • INTRATHECAL dexmedetomidine INJECTIONDrug

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

Study groups in NCT05262166
Study groupRoleWhat they receive
Epidural Fentanyl group:No interventionEpidural 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:ExperimentalIntrathecal dexmedetomidine plus heavy bupivacaine then general A
Receives: Drug: INTRATHECAL dexmedetomidine INJECTION

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total postoperative ANALGESIC fentanyl DOSE

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

    Measured: first 24 hours in both groups.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2022
  2. Study start10 Mar 2022 (estimated)
  3. Primary completion10 Aug 2022 (estimated)
  4. Study completion15 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05262166
Sponsor's protocol ID
MS.21.10.1699(date 21/11/2021)
Status last verified
Mar 2022
First submitted
4 Feb 2022
Last updated
2 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing INTRATHECAL dexmedetomidine INJECTION in people with Cancer, Bladder, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact MOHAMED A GHANEM (01067883998, MOHAMED.ABDEL_LATIF@YAHOO.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total postoperative ANALGESIC fentanyl DOSE (time frame: first 24 hours in both groups.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022.

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