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

NCT02616523 | Completed Phase 4 Results

• 1 other identifier: 23/07/14
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid-Related Disorders; Neuralgia

Keywords

dexmedetomidine; lidocaine; neuropathic pain; laparoscopic intestine resection; cognitive function

Outcome Measures

Primary Outcomes (1)

• Consumption of Fentanyl

  consumption of fentanyl (mg) during the procedure

  time of the operation

Secondary Outcomes (2)

• Consumption of Piritramide

  one hour after the operation

• Neuropathic Pain (Pain Questionnaire) dn4

  two months after the surgery

Other Outcomes (1)

• Complication

  up to two weeks

Study Arms (3)

dexmedetomidine

ACTIVE COMPARATOR

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; Drug: Fentanyl

lidocaine

ACTIVE COMPARATOR

Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.

Drug: Lidocaine; Drug: Fentanyl

placebo

PLACEBO COMPARATOR

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

Other: placebo; Drug: Fentanyl

Interventions

Dexmedetomidine DRUG

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

Also known as: Dexdor

dexmedetomidine

Lidocaine DRUG

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

Also known as: Xylocaine

lidocaine

placebo OTHER

The participants will be given infusion of normal saline intravenously.

placebo

Fentanyl DRUG

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

dexmedetomidine; lidocaine; placebo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• allergies to alpha 2 receptor agonists,
• uncontrolled arterial hypertension,
• nd 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-

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Related Publications (13)

• Vigneault L, Turgeon AF, Cote D, Lauzier F, Zarychanski R, Moore L, McIntyre LA, Nicole PC, Fergusson DA. Perioperative intravenous lidocaine infusion for postoperative pain control: a meta-analysis of randomized controlled trials. Can J Anaesth. 2011 Jan;58(1):22-37. doi: 10.1007/s12630-010-9407-0.

  PMID: 21061107 BACKGROUND

• Koppert W, Weigand M, Neumann F, Sittl R, Schuettler J, Schmelz M, Hering W. Perioperative intravenous lidocaine has preventive effects on postoperative pain and morphine consumption after major abdominal surgery. Anesth Analg. 2004 Apr;98(4):1050-1055. doi: 10.1213/01.ANE.0000104582.71710.EE.

  PMID: 15041597 BACKGROUND

• Gurbet A, Basagan-Mogol E, Turker G, Ugun F, Kaya FN, Ozcan B. Intraoperative infusion of dexmedetomidine reduces perioperative analgesic requirements. Can J Anaesth. 2006 Jul;53(7):646-52. doi: 10.1007/BF03021622.

  PMID: 16803911 BACKGROUND

• Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c.

  PMID: 18499604 BACKGROUND

• Shin JH, Howard FM. Abdominal wall nerve injury during laparoscopic gynecologic surgery: incidence, risk factors, and treatment outcomes. J Minim Invasive Gynecol. 2012 Jul-Aug;19(4):448-53. doi: 10.1016/j.jmig.2012.03.009. Epub 2012 May 3.

  PMID: 22560041 BACKGROUND

• Niccolai P, Ouchchane L, Libier M, Beouche F, Belon M, Vedrinne JM, El Drayi B, Vallet L, Ruiz F, Biermann C, Duchene P, Chirat C, Soule-Sonneville S, Duale C, Dubray C, Schoeffler P. Persistent neuropathic pain after inguinal herniorrhaphy depending on the procedure (open mesh v. laparoscopy): a propensity-matched analysis. Can J Surg. 2015 Apr;58(2):114-20. doi: 10.1503/cjs.008314.

  PMID: 25799247 BACKGROUND

• 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.

  BACKGROUND

• Deiner S, Silverstein JH. Postoperative delirium and cognitive dysfunction. Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i41-46. doi: 10.1093/bja/aep291.

  PMID: 20007989 BACKGROUND

• Jeanne M, Logier R, De Jonckheere J, Tavernier B. Heart rate variability during total intravenous anesthesia: effects of nociception and analgesia. Auton Neurosci. 2009 May 11;147(1-2):91-6. doi: 10.1016/j.autneu.2009.01.005. Epub 2009 Feb 8.

  PMID: 19201661 BACKGROUND

• Penney R. Use of dexmedetomidine and ketamine infusions during scoliosis repair surgery with somatosensory and motor-evoked potential monitoring: a case report. AANA J. 2010 Dec;78(6):446-50.

  PMID: 21309291 BACKGROUND

• Feld JM, Hoffman WE, Stechert MM, Hoffman IW, Ananda RC. Fentanyl or dexmedetomidine combined with desflurane for bariatric surgery. J Clin Anesth. 2006 Feb;18(1):24-8. doi: 10.1016/j.jclinane.2005.05.009.

  PMID: 16517328 BACKGROUND

• McCarthy GC, Megalla SA, Habib AS. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials. Drugs. 2010 Jun 18;70(9):1149-63. doi: 10.2165/10898560-000000000-00000.

  PMID: 20518581 BACKGROUND

• Andjelkovic L, Novak-Jankovic V, Pozar-Lukanovic N, Bosnic Z, Spindler-Vesel A. Influence of dexmedetomidine and lidocaine on perioperative opioid consumption in laparoscopic intestine resection: a randomized controlled clinical trial. J Int Med Res. 2018 Dec;46(12):5143-5154. doi: 10.1177/0300060518792456. Epub 2018 Sep 13.

  PMID: 30209962 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Neuralgia

Interventions

Dexmedetomidine; Lidocaine; Fentanyl

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines

Limitations and Caveats

Limitations of our study is that we have not evaluated inflammatory response on the cellular level. This should be investigated in the future studies to establish if dexmedetomidine and lidocaine have clinically important anti-inflammatory effect.

Results Point of Contact

• Title: dr. Lea Andjelković
• Organization: University Clinical Center Ljubljana

lea.andjelkovic@gmail.com

0038615223810

Study Officials

• Lea Andjelkovic, MD

  UMC Ljubljana Slovenia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 7, 2015
• First Posted: November 30, 2015
• Study Start: July 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: May 1, 2016
• Last Updated: October 11, 2016
• Results First Posted: July 11, 2016

Record last verified: 2016-08