Hemodynamic Changes During Operative Hysteroscopy

NCT ID: NCT03166228

Last Updated: 2022-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-05
• Study Completion Date: 2022-06-17

Brief Summary

Hysteroscopy is a minimally invasive gynaecological procedure in which an endoscopic optical lens is inserted through the cervix into the endometrial cavity to assists in the diagnosis of a vast number of uterine pathologies Historically, urologists used the resectoscope to perform a transurethral prostatectomy. This instrument was later modified to accommodate gynaecological applications. Operative hysteroscopy became popular after improvements in endoscopic technology and instruments in the 1970s and after the introduction of fluid distension media in the 1980s (1). During the past 2 decades, hysteroscopy has been increasingly used for operative procedures

Detailed Description

Operative hysteroscopy has become a standard surgical treatment for abnormal uterine bleeding unresponsive to conservative medical management since it was shown as a safe and effective alternative to hysterectomy.(2,3) Monopolar resectoscope necessitates an irrigating fluid that should be a non-conductive and salt free solution such as glycine 1.5% or sorbitol 3%.(4) Physiologic irrigating fluids (e.g. saline 0.9%) are contraindicated with these instruments since electric current generated by any monopolar electro surgical unit is preferentially conducted through low impedance fluid rather than through tissue and consequently it's difficult to initiate cutting and impossible to create significant tissue coagulation with these devices The clinical drawback of non-conductive irrigating solution (e.g. glycine 1.5%) is the risk of excessive fluid absorption leading to symptomatic dilutional hyponatremia and for hypotonic solutions, hypo-osmolarity and secondary cerebral oedema as Glycine is metabolized to carbon dioxide, water and ammonia, and may lead to intra-cellular over hydration and neurotoxicity which is clinically reflected as hypoxemia, agitation, nausea and hypertension.(5).Although rare, irreversible neurologic damage and death have been reported after excessive absorption of salt free irrigating solutions during routine operative hysteroscopy(6)Theoretically, distension with 0.9% saline as a distension medium avoids most of the above mentioned risks associated with hyper absorption of non electrolytic distension media(7) However, there is no doubt that excessive absorption of normal saline can be fatal(8).

Recently , it has been suggested that the type of anesthesia could modify fluid absorption(9). General anaesthesia has been associated with less Glycine absorption than epidural anaesthesia: the latter being associated with systemic vasodilatation(9).

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

normal saline0.9%

0.9% saline distension media is used as long as diathermy is not in use

Group Type: ACTIVE_COMPARATOR

Normal Saline 0.9% Infusion Solution Bag

Intervention Type: DRUG

0.9% saline as distension medium as long as diathermy is not in use

1.5% GLYCINE

1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use

Group Type: PLACEBO_COMPARATOR

1.5% Glycine only

Intervention Type: DRUG

1.5% Glycine alone during hysteroscopy as long as diathermy is in use

Interventions

Normal Saline 0.9% Infusion Solution Bag

0.9% saline as distension medium as long as diathermy is not in use

Intervention Type: DRUG

1.5% Glycine only

1.5% Glycine alone during hysteroscopy as long as diathermy is in use

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• In this study we will include 60 patients (age ranged from 20 to 40 years) with uterine size less than 12 weeks and cavity depth less than 12cm. Different types of intrauterine lesions (submucous fibroids of types 0, 1 and 2 with diameter less than 4 cm, polyps,septum and adhesions).

Exclusion Criteria

• Any case with the following diseases will be excluded from the study.
• Cardiac diseases (myocardial ischemia, myocardial infarction or valve lesions).
• Renal impairment.
• Neurological affection.
• Chest diseases.
• Hepatic impairment.
• coagulation abnormalities.
• Patient refusal.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

ahmed sonbaty

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHMED sonbaty, doctor

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut University

Asyut, , Egypt

Countries

Egypt

Other Identifiers

ahmed 2017

Identifier Type: -

Identifier Source: org_study_id