Reducing Gas Embolisation During Hysteroscopic Surgery by limiting the amount of intravasation with the installation of intracervical terlipressin (HYSTER)

Trans Cervical Resection of Myoma (TCRM) and Endometrium (TCRE) are safe 
hysteroscopic minimal invasive procedures. However, in a previous study we 
observed by TOE venous gas embolism (VGE) in almost every patient irrespective 
of mode of diathermia. In addition, paradoxical gas embolism was observed in 
several patients. This might be a potentially dangerous phenomenon. 
Hysteroscopic derived gas embolisation has been shown to be correlated to the 
amount of intravasation.
Previous studies indicate that transcervical surgery should be discontinued 
when intravasation exceeds 2000 ml. In such case, surgery sometimes has to be 
stopped and patients will have to undergo a second operation for removal of 
remaining tissue. 
In gynaecologic surgery vasopressin has been used since the 1950s., The 
installation of intracervical vasopressin has been shown to limit the amount of 
intravasation. Therefore, its use may be beneficial in hysteroscopic surgery. 
Whether the insertion of intracervical vasopressin leads to a lower incidence 
and severity of gas embolism is unknown. In some European countries vasopressin 
is not available and thus terlipressin, a synthetic long-acting analogue of 
vasopressin, is used. We assume that terlipressin has the same effect on 
intravasation as vasopressin. 
Vasopressin and terlipressin (triglycyl lysine vasopressin) are commonly used 
drug with different indications. Owing to its pronounced vasoconstrictive 
effect within the splanchnic circulation, terlipressin is widely used 
particularly in the management of patients with variceal bleeding, in the 
treatment of hepatorenal syndrome and catecholamine-unresponsive septic shock. 
In gynaecological practice terlipressine is commonly used to prevent bleeding 
during conisation.

Because in our previous studies more gasembolism was seen as intravasation 
increased we hypothesize that intracervical terlipressin leads to less 
gasembolism by lowering the amount of intravasation 

This is the first study on the effect of terlipressine on intravasation and 
gasembolism.

Objective: 

The primary objective of the study is to determine whether the intracervical 
installation of vasopressin reduces the incidence and severity of gas embolism 
as detected by trans oesophageal echocardiography (TOE).

The secondary objective is to study the effects of intracervical installation 
of vasopressin on intravasation, global hemodynamics, myocardial ventricular 
systolic strain and myocardial diastolic function using TOE. 

A substudy will be done analysing the laboratory results obtained during the 
procedure to determine electrolyte changes and assessing acid-base disturbances 
using the Stewart*s approach.

After receiving informed consent 48 patients will be included in the study. In 
a double blinded fashion patients will be randomised to surgical treatment 
using either intracervical terlipressin or intracervical placebo.

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.

 

The use of terlipressin is potentially beneficial with respect to its ability 
to diminish intravasation in hysteroscopic surgery. Because intravasation is 
limited to 2000 ml to prevent complications due to fluid overload, 
terlipressine may increase the chance on completely removing the tissue and 
thus preventing second procedures. Terlipressin is frequently used in 
gynaecological surgery to limit blood loss during conisation for cervical 
dysplasia.. However, terlipressin is also known for its strong effects on 
systemic vascular resistance. Therefore it may be less well tolerated in 
patients with diminished cardiac function.

There is a limited risk related to the placement a TOE probe in the mid 
oesophageal position under general anesthesia. However, it is nowadays 
considered as routine monitor during heart surgery and during procedures with 
expected or known instability. In general this is considered a safe 
non-invasive technique. Only very few cases of hypopharynx or oesophageal 
perforation have been reported. Potential benefit lies in the early detection 
and treatment of progressive right and left ventricular dysfunction as well as 
severe life threatening paradoxical embolism.