CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Dexmedetomidine +3 moredrug
Likely dose
Dexmedetomidine 0,5 mcg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02616523
NCT02616523Phase 4Completed

Influence of Dexmedetomidine and Lidocaine on Opioid Consumption, Cognitive Function and Incidence of Neuropathic Pain in Laparoscopic Intestine Resection

University Medical Centre Ljubljana·interventional·Posted Nov 30, 2015·Updated Oct 11, 2016

In Brief

A Phase 4 clinical trial evaluating Dexmedetomidine, Lidocaine, and 2 other interventions for Opioid-Related Disorders and Neuralgia. Completed, enrolled 60 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 30, 2015
Enrollment StartJul 1, 2014
Primary CompletionJun 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.6 years ago

Interventions

Dexmedetomidinedrug

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

Lidocainedrug

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

placeboother

The participants will be given infusion of normal saline intravenously.

Fentanyldrug

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