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

NCT02616523 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-10-11

Study results available
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Summary

Using combination of opioid analgesics and analgesics with different mechanism of action the investigators can decrease the consumption of opioid analgesics and their side effects. The investigators will use opioid analgesic fentanyl alone or in combination with dexmedetomidine or lidocaine.The participants scheduled for laparoscopic intestine resection will be divided in three groups: in the first group, the participants will receive single boluses of fentanyl, in the second group, the participants will receive continuous infusion of lidocaine and single boluses of fentanyl, and in the third group, the participants will receive continuous infusion of dexmedetomidine and single boluses of fentanyl. Participants with intraoperative infusion od dexmedetomidine or lidocaine will need less boluses of fentanyl during the operation and less opioid analgesics after the operation in comparison to those who will receive only fentanyl boluses. Better cognitive function after the operation is expected in participants receiving dexmedetomidine infusion. There will be minimal incidence of neuropathic pain because of minimal surgical injury of peripheral nerves in all groups of patients.

Conditions

  • Opioid-Related Disorders
  • Neuralgia

Interventions

DRUG

Dexmedetomidine

The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.

DRUG

Lidocaine

The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.

OTHER

placebo

The participants will be given infusion of normal saline intravenously.

DRUG

Fentanyl

Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50.

Sponsors & Collaborators

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Lea Andjelkovic, MD · UMC Ljubljana Slovenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-06-30
Completion
2016-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02616523 on ClinicalTrials.gov