Sedative effect during gastroscopy
Conditions
Interventions
Trade Name: Alfentanil Hameln
Pharmaceutical Form: Injection
Trade Name: Midazolam Panpharma
Product Name: Midazolam Panpharma
Product Code: 15745
Pharmaceutical Form: Injection
Sponsors
Medicinkliniken, Sjukhuset Lidköping
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient between 18-80 years old Refererred for policlinical routine gastroscopy In need of sedative agent Patient can communicate 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Allergies to any of the used agents Unable to communicate Any planned therapuetical interventions Patient has a suspected alcohol, narcotic och abuse of other drugs, or previous abuse Pregnant patient Severe lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if midazolam and alfenatnil have same sedative effect and if rapifed;Secondary Objective: If rapifes has less post procedural side effect;Primary end point(s): If the patient can leave the practice earlier if given Alfentanil If the sedative effect is non-inferior to midazolam;Timepoint(s) of evaluation of this end point: Evaluation when patient leaves the practice | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of examinations cancelled or aborted due to ineffective sedation. Patients experience of the examination. The doctors experience of the sedatives potency. comparison of side eccets. If the patient can see themselves undergo a new examination in the furutre.;Timepoint(s) of evaluation of this end point: During the examination and when the patient leaves the practice | — |
Countries
Sweden
Contacts
Public ContactMedicinkliniken, Skas L
Skaraborgs Sjukhus
Outcome results
None listed