NCT03393988

Brief Summary

This study,will evaluate the efficacy of ultrasound (US)-guided subcostal oblique TAP block together with IV infusion of Dexmedetomidine and fentanyl as a type of multimodal analgesic regimen in comparison with IV fentanyl based analgesia only in live liver donors.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 7, 2017

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 9, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 9, 2018

Status Verified

January 1, 2018

Enrollment Period

12 months

First QC Date

December 23, 2017

Last Update Submit

January 8, 2018

Conditions

Anesthesia

Keywords

Transversus abdominis plane block,DexmedetomidineFentanylLive liver donorLiver transplantation

Outcome Measures

Primary Outcomes (1)

  • Total fentanyl consumption

    Total Intravenous fentanyl consumption during the operation

    Intraoperative

Secondary Outcomes (3)

  • Average sevoflurane concentration

    Intraoperative

  • The severity of postoperative nausea and vomiting (PONV)

    First 24 hours postoperatively

  • Ramsay sedation score (RSS)

    First 24 hours postoperatively

Study Arms (2)

Group F

ACTIVE COMPARATOR

Fentanyl infusion (0.5 µg/kg/hr)

Drug: Fentanyl infusion

Group (TAP-Dex)

ACTIVE COMPARATOR

Ultrasound guided TAP block and Dexmedetomidine * Ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine * Dexmedetomidine infusion(200 µg in 2 ml diluted in 48 ml of saline) * Fentanyl infusion (0.5 µg/kg/hr).

Drug: Fentanyl infusionProcedure: Ultrasound guided TAP blockDrug: Dexmedetomidine

Interventions

Fentanyl infusionDRUG

After induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading).

Also known as: Opioid
Group (TAP-Dex)Group F
Ultrasound guided TAP blockPROCEDURE

After induction of general anesthesia; Patients will receive ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine 40 ml on each side resulting in a total volume of 80 ml, subcostal TAP block was given twice, at the beginning and at the end of the surgery.

Also known as: Regional anesthesia
Group (TAP-Dex)
DexmedetomidineDRUG

Dexmedetomidine (200 µg in 2 ml diluted in 48 ml of saline) will be started in a dose of 1 μg/kg over 10 min then maintenance dose as continuous infusion between 0.2 and 0.8 μg/ kg/h through infusion pump (which will be adjusted according to the hemodynamics and BIS reading)

Also known as: alpha 2 sympathomimetic
Group (TAP-Dex)

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesia (ASA) physical status I or II
  • Scheduled as live liver donors
  • J-shaped incision in the supraumblical region

You may not qualify if:

  • Patients with a history of psychiatric/neurological illness,
  • Hypertensive patients,
  • Morbidly obese patients,
  • Pregnant and nursing women,
  • Patients with known allergic reaction to any of the study medications,
  • Patients on recent use of sedatives or analgesics,
  • Patients with significant laboratory abnormalities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospitals of Faculty of Medicine , Ain Shams University

Cairo, 11591, Egypt

Location

MeSH Terms

Interventions

Analgesics, OpioidAnesthesia, ConductionDexmedetomidine

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic UsesAnesthesiaAnesthesia and AnalgesiaImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 23, 2017

First Posted

January 9, 2018

Study Start

December 7, 2017

Primary Completion

December 1, 2018

Study Completion

February 1, 2019

Last Updated

January 9, 2018

Record last verified: 2018-01

Locations

EG(1)