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Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03328299
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
21.7
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

TAP-block has been shown to be a safe and effective postoperative analgesia method in a variety of general. Dexmedetomidine is a selective α2 agonist with 8 times more affinity for α2 adrenergic receptors compared to clonidine and possesses all the properties of α2 agonist without respiratory depression. Dexmedetomidine has been focus of interest for its broad spectrum (sedative, analgesic and anesthetic sparing) properties, making it a useful and safe adjunct in many clinical applications.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block for Patient Undergoing Lower Abdominal Surgery
Actual Study Start Date :
Nov 11, 2017
Actual Primary Completion Date :
Dec 1, 2018
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dexmedetomidine group

patients were given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine + dexmedetomidine 1 μg•kg-1 diluted in 20 ml saline

Drug: Dexmedetomidine
20 ml of 0.5 % bupivacaine plus dexmedetomidine 1 μg•kg-1
Other Names:
  • active group

    		•
    Placebo Comparator: bupivacaine group

    patients will given ultrasound guided TAP-block with 20 ml of 0.5 % bupivacaine

    Drug: bupivacaine
    20 ml of 0.5 % bupivacaine
    Other Names:
  • control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. measure dexmedetomidine level into systemic circulation after local administration [up to 6 hours]

      assessment of systemic dexmedetomidine level after local administration in TAP block after 15 minutes after giving the block, 30 min, 45 min, 1hrs, 2hrs, 4hrs and 6

    Secondary Outcome Measures

    1. total dose of IV PCA morphine consumption in the first 24 h postoperative [24 hours]

      postoperative morphine consumption

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 24 ASA I-II

    • patients (age 18-60 years

    • weight 50-89 kg

    Exclusion Criteria:

    • a known allergy to the study drugs

    • significant cardiac

    • respiratory, renal or hepatic diseases

    • bleeding diathesis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Egypt Cancer instIitute Assuit Egypt 171516

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fatma Adel El sherif,MD, lecturer of anesthesia , ICU and pain management, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03328299
    Other Study ID Numbers:
    • 402
    First Posted:
    Nov 1, 2017
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Pain, Postoperative
    Dexmedetomidine
    Bupivacaine

    Study Results

    No Results Posted as of Oct 22, 2020