Effect on post operative opioid consumption after laparoscopic gastric by-pass in obese
Conditions
Interventions
Trade Name: Brevibloc
Pharmaceutical Form: Solution for injection
Trade Name: Remifentanil Teva
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
Sponsors
Univeritetssjukhuset Örebro
Universitetssjukhuset Örebro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-65 year of age, male or female planned for laparoscopic gastric by-pass surgery 2. Signed and dated informed consent 3. The volunteer is willing and thought to be able to follow the study protocol 4. BMI > 35kg/m2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe cardiovascular disease or cardiovascular disease with ongoing treament with beta- and/or alfa-receptor antagonist and/or calcium channel inhibitor 2.Ongoing treatment with opioids 3. ECG with atrio-ventricular block II-III or other severe form of conduction disturbance (e.g. long QT-syndrome) 4. Allergy or sensitivity to remifentanil, fentanyl like opioids, esmolol or other compounds 5. Pregnancy or breast feeding. 6. Participation in a ongoing drug study or, during the last year participated in a drug study where opioid is included or participation in a pharmacological study of any kind the last 30 days or where the monitoring is not yet completed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is the cumulative dose of opioid 2 hours postoperative reduced in the group treated with esmolol during surgery compared with the group treated with remifentanil?;Secondary Objective: Is the cumulative dose of opioid 24 hours postoperative reduced in the group treated with esmolol during surgery compared with the group treated with remifentanil? Can the intra operative use of esmolol instead of remifentanil reduce postoperative nausea and vomiting?;Primary end point(s): Cumulative consumption of morphine (mg) at time 2 hours post-operative;Timepoint(s) of evaluation of this end point: 2 hours post operative | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Cumulative consumption of morphine (mg) at time 24 hours post-operative 2. Nausea or vomiting at time 2 an 24 hours post operative 3. Number of doses of anti-emetics administered ;Timepoint(s) of evaluation of this end point: 1. 24 hours post operative 2. 2 and 24 hours post operative 3. 2 and 24 doses post operative | — |
Countries
Sweden
Contacts
Public ContactUniversitetssjukhuset Örebro
Universitetssjukhuset Örebro
Outcome results
None listed