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

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ClinicalTrials.gov Identifier: NCT02616523
Recruitment Status : Completed
First Posted : November 30, 2015
Results First Posted : July 11, 2016
Last Update Posted : October 11, 2016
Sponsor:
Information provided by (Responsible Party):
Lea Andjelkovic, University Medical Centre Ljubljana

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Neuralgia Drug: Dexmedetomidine Drug: Lidocaine Other: placebo Drug: Fentanyl Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Influence of Dexmedetomidine and Lidocaine on Opioid Consumption, Cognitive Function and Incidence of Neuropathic Pain in Laparoscopic Intestine Resection
Study Start Date : July 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: dexmedetomidine
The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.
Drug: Dexmedetomidine
The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.
Other Name: Dexdor

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.

Active Comparator: lidocaine
Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.
Drug: Lidocaine
The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.
Other Name: Xylocaine

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.

Placebo Comparator: placebo
The placebo group will receive intravenous infusion of normal saline only.
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.




Primary Outcome Measures :
  1. Consumption of Fentanyl [ Time Frame: time of the operation ]
    consumption of fentanyl (mg) during the procedure


Secondary Outcome Measures :
  1. Consumption of Piritramide [ Time Frame: one hour after the operation ]
    consumption of piritramide (mg) in the recovery room

  2. Neuropathic Pain (Pain Questionnaire) dn4 [ Time Frame: two months after the surgery ]
    Pain questionnaire dn4 will be send to participants after two months of surgery to evaluate the neuropathic pain. There are minimum 0 points and maximum 10 points. If the score is 4 or higher then the pain is likely to be neuropathic pain.


Other Outcome Measures:
  1. Complication [ Time Frame: up to two weeks ]
    complications such as obstipation in the postoperative period



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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02616523


Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Lea Andjelkovic, MD UMC Ljubljana Slovenia

Publications:
Spindler Vesel A, Vrečar V, Repar A, Požar Lukanović N. Efficiency of PCA with piritramid and postoperative occurence of neuropathic pain in laparoscopic and clasical colorectal surgery. In: Della Roca G, De Monte A, eds. Proceedings of 25th Anesthesia And ICU Symposium Alpe-Adria. Udine, 2012:90-3.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lea Andjelkovic, MD, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02616523     History of Changes
Other Study ID Numbers: 23/07/14
First Posted: November 30, 2015    Key Record Dates
Results First Posted: July 11, 2016
Last Update Posted: October 11, 2016
Last Verified: August 2016
Keywords provided by Lea Andjelkovic, University Medical Centre Ljubljana:
dexmedetomidine
lidocaine
neuropathic pain
laparoscopic intestine resection
cognitive function
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Neuralgia
Opioid-Related Disorders
Peripheral Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Fentanyl
Dexmedetomidine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Analgesics
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists