Intracervical installation of terlipressin reduces the incidence and severity of gas embolsim and the amount of intravasation during hysteroscopic surgery
ID
Source
Brief title
Health condition
myoma. menorrhagia
Sponsors and support
OLVG, Oosterpark 9, 1091 AC Amsterdam, l.e.overdijk@olvg.nl, 020-599111
Intervention
Outcome measures
Primary outcome
to determine whether the intracervical insallation of terlipressin reduces the inncidence and severity of gas embolsim as detected by trans oesophageal echocardiography (TOE)
Secondary outcome
to study the effect of intracervical terlipressin on the amont of intravasation, global hemodynamics, myocardial ventricular systolic strain and myocardial diastolic funcion using TOE. A substudy will be done analysing the laboratoy results to determine elceltrlyte changes and assessing acid-base disturbances.
Background summary
TCR-M an TCR-E are safe hysteroscopic minimal invasive procedures. However, in a previous study we observed by TOE venous gas embolsim in almost every patient. This might be a potentially dangerous phenomenon. Hysteroscopic derived gas embolism has been shown to be correlated to the amount of intravasation. The installation of intracervical vasopressin has been shown to limit the amount of intravasation, therefore its use may be beneficial in hysteroscopic surgery leading to a lower incidence and severity of gas embolism. We use terlipressin (a synthetic long acting analogue of vasopressin)instead of vasopressin because vaspressin is not avalibale in our country, assuming terlipressine has the same effect on intravasation.
Study objective
Intracervical installation of terlipressin reduces the incidence and severity of gas embolsim and the amount of intravasation during hysteroscopic surgery
Study design
during surgery till 3 hours postoperative
Intervention
Intracervical installation of terlipressin vs placebo
Inclusion criteria
48 patiens (ASA classification 1 or 2) secheduled for trans cervical resection of large type 1-2 moma's (TCR-M) or extensive trans cervical endometrium resection (TCR-E)
Exclusion criteria
Trans cervical operations of small myoma's and minor TCR-E procedures.
Short lasting procedures of < 1/2 hour.
Contraindication for transesophageal echocardiography (severe oesopageal or gastric disease, hepatic cirrhosis of known oesphageal varices.
Patients < 18 yr or > 70 yr.
Histroy of pulmonary embolism, cardiac disease or oesphageal disease. Patient wih language barrier.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5344 |
| NTR-old | NTR5577 |
| EudraCT | EUCTR2013-000006-28-NL |
| CCMO | NL45004.100.13 |
| OMON | NL-OMON41343 |