menorrhagia myoma vaginal bleeding
Conditions
Interventions
All interventions are performed under general anesthesia
•Patients will receive either intracervical terlipressin or placebo. (20 ml 
diluted terlipressin 0.0425 mg/ml = one vial Glypressine® 8,5 ml containing 0.1 
mg terlipressin /ml diluted with 11.5 ml NaCl 0.9%)
•A TOE probe will be inserted to record amount and severity of embolic events 
and to observe cardiac function.
•A continuous non-invasive blood pressure and cardiac output monitor system 
will be applied on the middle finger.
•Before start an at the end of the procedure an venous blood sample will be 
taken for blood gas analysis and measurement of haemoglobin and haematocrit. 
From one of the blooodsamples the albumine content will be determined and 3 
hours postoperative the troponine content.
 
Sponsors
Onze Lieve Vrouwe Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: ASA classification 1 or 2, scheduled for trans cervical resection of large type 1-2 myoma*s (TCR-M) or extensive trans cervical endometrium resection (TCR-E)
Exclusion criteria
Exclusion criteria: - Patients undergoing trans cervical operations of small myoma*s and minor TCR-E procedures. - Procedures that are expected to be short lasting (less than * hour) are excluded. - Patient with a known contraindication for TEE such as severe oesophageal or gastric disease, hepatic cirrhosis of known oesophageal varices - Patients younger than 18 yr or older than 70 yr - Patients with a history of pulmonary embolism, cardiac disease or oesophageal disease - Patients with language barrier will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter is the appearance of venous embolism either venous or paradoxical of origin. The severity of the embolism will be assessed using a five point grading scale. In addition, the duration of the embolic phenomena will be recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.For assessment of hemodynamics derived from embolic events or from possible systemic effects of terlipressin. •Global hemodynamics will be measured with a non-invasive beat to beat hemodynamic monitor Nexfin HD (BMEYE B.V, Amsterdam, Netherlands) providing continuous data including blood pressure, cardiac output and systemic vascular resistance. •Measurements of systolic and diastolic cardiac function will be assessed by TOE before and just after surgery. 2.For assessment of effects of terlipressin on intravasation •Intravasation will be calculated by subtracting the amount of fluid introduced via the resectoscope and the amount of fluid collected by fluid suction. •Intravasation will be calculated by assessment of changes of haematocrit. 3. Analysis of electrolyt and acid base balance disturbances. | — |
Countries
Netherlands
Outcome results
None listed