Trial Outcomes & Findings for Influence of Dexmedetomidine and Lidocaine on Opioid Consumption in Laparoscopic Intestine Resection (NCT NCT02616523)
NCT ID: NCT02616523
Last Updated: 2016-10-11
Results Overview
consumption of fentanyl (mg) during the procedure
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
time of the operation
Results posted on
2016-10-11
Participant Flow
The study was conducted between June 2014 and April 2015 at Ljubljana University Medical Centre, Slovenia.
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.
Participant milestones
| Measure |
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.
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
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.
|
Placebo
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 Study
STARTED
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Influence of Dexmedetomidine and Lidocaine on Opioid Consumption in Laparoscopic Intestine Resection
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=19 Participants
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
n=20 Participants
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.
|
Placebo
n=20 Participants
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
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66 years
STANDARD_DEVIATION 12 • n=99 Participants
|
61 years
STANDARD_DEVIATION 11 • n=107 Participants
|
58 years
STANDARD_DEVIATION 12 • n=206 Participants
|
62 years
STANDARD_DEVIATION 12 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: time of the operationconsumption of fentanyl (mg) during the procedure
Outcome measures
| Measure |
Dexmedetomidine
n=19 Participants
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
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Consumption of Fentanyl
|
41 mg
Standard Deviation 10
|
50 mg
Standard Deviation 18
|
58 mg
Standard Deviation 21
|
SECONDARY outcome
Timeframe: one hour after the operationconsumption of piritramide (mg) in the recovery room
Outcome measures
| Measure |
Dexmedetomidine
n=19 Participants
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
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Consumption of Piritramide
|
4.63 mg
Standard Deviation 4.95
|
5.25 mg
Standard Deviation 7.04
|
4.25 mg
Standard Deviation 2.95
|
SECONDARY outcome
Timeframe: two months after the surgeryPain 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.
Outcome measures
| Measure |
Dexmedetomidine
n=19 Participants
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
n=20 Participants
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.
|
Placebo
n=20 Participants
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.
|
|---|---|---|---|
|
Neuropathic Pain (Pain Questionnaire) dn4
|
0.11 units on a scale
Standard Deviation 0.46
|
0.00 units on a scale
Standard Deviation 0.00
|
0.45 units on a scale
Standard Deviation 0.83
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to two weekscomplications such as obstipation in the postoperative period
Outcome measures
Outcome data not reported
Adverse Events
Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
dr. Lea Andjelković
University Clinical Center Ljubljana
Phone: 0038615223810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place