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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Conditions Opioid-Related Disorders
Neuralgia
Interventions Drug: Dexmedetomidine
Drug: Lidocaine
Other: placebo
Drug: Fentanyl
Enrollment 60
Recruitment Details The study was conducted between June 2014 and April 2015 at Ljubljana University Medical Centre, Slovenia.
Pre-assignment Details We excluded from the study: the participants with allergies to α2 receptor agonists, uncontrolled arterial hypertension, 2nd and 3rd degree atrioventricular block, alcohol abusers, clinically important neurological, cardiovascular, respiratory, renal, liver, and gastrointestinal disease, pregnant women and participants younger than 18 years.
Arm/Group Title Dexmedetomidine Lidocaine Placebo
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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.

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

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

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

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

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

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

placebo: The participants will be given infusion of normal saline intravenously.

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

Period Title: Overall Study
Started 20 [1] 20 [1] 20 [1]
Completed 19 [2] 20 [2] 20 [2]
Not Completed 1 0 0
[1]
June 2014
[2]
April 2015
Arm/Group Title Dexmedetomidine Lidocaine Placebo Total
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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.

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

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

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

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

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

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

placebo: The participants will be given infusion of normal saline intravenously.

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

Total of all reporting groups
Overall Number of Baseline Participants 19 20 20 59
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 20 participants 20 participants 59 participants
66  (12) 61  (11) 58  (12) 62  (12)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 20 participants 20 participants 59 participants
Female
10
  52.6%
8
  40.0%
10
  50.0%
28
  47.5%
Male
9
  47.4%
12
  60.0%
10
  50.0%
31
  52.5%
1.Primary Outcome
Title Consumption of Fentanyl
Hide Description consumption of fentanyl (mg) during the procedure
Time Frame time of the operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Lidocaine Placebo
Hide Arm/Group Description:

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.

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

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

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

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

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

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

placebo: The participants will be given infusion of normal saline intravenously.

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

Overall Number of Participants Analyzed 19 20 20
Mean (Standard Deviation)
Unit of Measure: mg
41  (10) 50  (18) 58  (21)
2.Secondary Outcome
Title Consumption of Piritramide
Hide Description consumption of piritramide (mg) in the recovery room
Time Frame one hour after the operation
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Lidocaine Placebo
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Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
Participants received fentanyl boluses during the operation
Overall Number of Participants Analyzed 19 20 20
Mean (Standard Deviation)
Unit of Measure: mg
4.63  (4.95) 5.25  (7.04) 4.25  (2.95)
3.Secondary Outcome
Title Neuropathic Pain (Pain Questionnaire) dn4
Hide Description 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.
Time Frame two months after the surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dexmedetomidine Lidocaine Placebo
Hide Arm/Group Description:
Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
Participants received fentanyl boluses during the operation
Overall Number of Participants Analyzed 19 20 20
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.11  (0.46) 0.00  (0.00) 0.45  (0.83)
4.Other Pre-specified Outcome
Title Complication
Hide Description complications such as obstipation in the postoperative period
Time Frame up to two weeks
Outcome Measure Data Not Reported
Time Frame 2 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dexmedetomidine Lidocaine Placebo
Hide Arm/Group Description

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.

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

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

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

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

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

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

placebo: The participants will be given infusion of normal saline intravenously.

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

All-Cause Mortality
Dexmedetomidine Lidocaine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dexmedetomidine Lidocaine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dexmedetomidine Lidocaine Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/20 (0.00%)   0/20 (0.00%) 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: dr. Lea Andjelković
Organization: University Clinical Center Ljubljana
Phone: 0038615223810
EMail: lea.andjelkovic@gmail.com
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.
Layout table for additonal information
Responsible Party: Lea Andjelkovic, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT02616523     History of Changes
Other Study ID Numbers: 23/07/14
First Submitted: November 7, 2015
First Posted: November 30, 2015
Results First Submitted: May 28, 2016
Results First Posted: July 11, 2016
Last Update Posted: October 11, 2016