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Influence of Dexmedetomidine and Lidocaine on Opioid Consumption in Laparoscopic Intestine Resection

NCT02616523Phase 4

Key facts

Status: Completed
Start: Jul 2014
Primary completion: Jun 2015
Sponsor: University Medical Centre Ljubljana
Modality: Small Molecules

Drugs: dexmedetomidineLidocaine Hydrochloride Injection, without epinephrine
Conditions: opioid use disorder (OUD)Neuralgia

Overview

Phase 4, randomised trial in opioid use disorder (OUD) and Neuralgia comparing dexmedetomidine, lidocaine and placebo (3 arms). Primary endpoint: Consumption of Fentanyl. Started Jul 2014; status: completed.

Design

3 arms

Study design: Randomized

dexmedetomidine
Dexmedetomidine infusion 0.5 mcg/kg/h + Fentanyl boluses
lidocaine
Lidocaine infusion 1.5 mg/kg/h + Fentanyl boluses
placebo
Normal saline infusion + Fentanyl boluses

Who it enrols

Adult patients aged 35-85 with ASA 2-3 undergoing planned laparoscopic intestine resection, excluding those with specific cardiovascular, neurological, respiratory, renal, liver, or gastrointestinal diseases, pregnant women, and substance abusers.

Endpoints

Primary

Consumption of Fentanyltime of the operation

Secondary

Consumption of Piritramideone hour after the operation
Neuropathic Pain (Pain Questionnaire) dn4two months after the surgery

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