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OpenTrials
Completed

NCT Number: NCT03328299

Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

South Egypt Cancer instIitute

Asyut, 171516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

20 ml of 0.5 % bupivacaine plus dexmedetomidine 1 μg•kg-1

Other names: active group

Bupivacaine

Drug

20 ml of 0.5 % bupivacaine

Other names: control

Primary outcomes

  1. measure dexmedetomidine level into systemic circulation after local administration

    Time frame: 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 outcomes

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

    Time frame: 24 hours

    postoperative morphine consumption

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Pharmacokinetics and Dynamics of Dexmedetomidine as Adjuvant in TAP Block for Patient Undergoing Lower Abdominal Surgery

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Nov 1, 2017
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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