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Phase 4 N=60 Randomized Single-blind Treatment

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

Opioid-Related Disorders · Neuralgia

Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: Consumption of Fentanyl — 41; 50; 58 mg

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Dexmedetomidine (Drug); Lidocaine (Drug); placebo (Other); Fentanyl (Drug)
Age
Adult, Older Adult · 35+ yrs
Sex
All
Sponsor
University Medical Centre Ljubljana
Primary completion
Jun 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Consumption of Fentanyl
41; 50; 58
SECONDARY
Consumption of Piritramide
4.63; 5.25; 4.25
SECONDARY
Neuropathic Pain (Pain Questionnaire) dn4
0.11; 0.00; 0.45

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.

Eligibility Criteria

Inclusion Criteria

  • patients aged 35 to 85,
  • ASA 2-3 (according to the classification of American Society of Anesthesiologists),
  • undergoing a planned laparoscopic intestine resection at the Department of Abdominal Surgery at the University Medical Centre Ljubljana.

Exclusion Criteria

  • allergies to alpha 2 receptor agonists,
  • uncontrolled arterial hypertension,
  • 2nd and 3rd degree atrioventricular block,
  • alcohol and illegal drugs abusers,
  • patients with clinically important neurological, cardiovascular, respiratory (COPD, emphysema), renal, liver, and gastrointestinal disease,
  • pregnant women,
  • patients younger than 18 years-
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02616523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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