E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Effect on post operative opioid consumption after laparoscopic gastric by-pass in obese |
Effekt på postoperativ opioidkonsumtion i samband med laparoskopisk gastric by-pass kirurgi |
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E.1.1.1 | Medical condition in easily understood language |
Effect on post operative opioid consumption after laparoscopic gastric by-pass in obese |
Effekt på postoperativ opioidkonsumtion i samband med laparoskopisk gastric by-pass kirurgi |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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? |
Är den post-operativa kumulativa konsumtionen av opioid vid tid 2 timmar postoperativt lägre i gruppen som behandlats med esmolol än gruppen som behandlats med remifentanil? |
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E.2.2 | Secondary objectives of the trial |
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? |
Är den post-operativa kumulativa konsumtionen av opioid vid tid 24 timmar postoperativt (kumulativ dos) lägre i gruppen som behandlats med esmolol än gruppen som behandlats med remifentanil?
Kan esmolol minska grad av postoperativt illamående?
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
1. 18-65 år man eller kvinna som genomgår laparoskopisk gastric by-pass kirurgi.
2. Signerat och daterat informerat samtycke
3. Försökspersonen vill och bedöms kunna följa protokollet under studietiden.
4. BMI > 35Kg/m2
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E.4 | Principal 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
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1. Känd svår hjärt/kärlsjukdom eller hjärt/kärlsjukdom med pågående behandling med beta- och/eller alfa-receptor antagonist och/eller kalciumantagonist.
2. Pågående opioidbehandling
3. EKG med AV-block II-III eller annat allvarligt retledningshinder (ex långt QT.syndrom)
4. Allergi eller känd överkänslighet för remifentanil, fentanylanaloger, esmolol eller övriga innehållsämnen
5. Graviditet eller amning
6. Under det senaste året medverkat i en läkemedelsstudie där opioid använts eller under den senaste 30 dagarna deltagit annan läkemedelsstudie eller medverkar i läkemedelsstudie där uppföljningen inte är avslutad.
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E.5 End points |
E.5.1 | Primary end point(s) |
Cumulative consumption of morphine (mg) at time 2 hours post-operative |
Kumulativ morfinkonsumtion vid tid 2 timmar postoperativt (mg) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 hours post operative |
2 timmar postoperativt |
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E.5.2 | 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 |
1. Kumulativ morfinkonsumtion vid 24 timmar postoperativt (mg).
2. Subjektiv känsla av illamående vid tid 2 och 24 timmar.
3. Antal doser administrerad antiemetika vid tid 2 och 24 timmar postoperativt.
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E.5.2.1 | 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 |
1. 24 timmar postoperativt
2. 2 och 24 timmar postoperativt
3. 2 och 24 timmar postoperativt |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS |
Sista försökspersonen genomför sista besöket |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |