What is the post operative opioid-reducing effect of the beta-receptor-agonist esmolol when administered during laparoscopic gastric by-pass surgery? Comparison between standard anesthesia and anesthesia when remifentanil is replaced with esmolol.
- Conditions
- Effect on post operative opioid consumption after laparoscopic gastric by-pass in obeseTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Registration Number
- EUCTR2014-003713-28-SE
- Lead Sponsor
- niveritetssjukhuset Örebro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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?<br>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 Outcome Measures
Name Time Method Secondary end point(s): 1. Cumulative consumption of morphine (mg) at time 24 hours post-operative<br>2. Nausea or vomiting at time 2 an 24 hours post operative<br>3. Number of doses of anti-emetics administered ;Timepoint(s) of evaluation of this end point: 1. 24 hours post operative<br>2. 2 and 24 hours post operative<br>3. 2 and 24 doses post operative