Hemodynamic Changes During Operative Hysteroscopy

Hematological, Biochemical and Hemodynamic Changes During Operative Hysteroscopy Using Consecutive Distension Media

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

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Drug: Normal Saline 0.9% Infusion Solution Bag; Drug: 1.5% Glycine only

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).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: normal saline0.9%; 0.9% saline distension media is used as long as diathermy is not in use	Drug: Normal Saline 0.9% Infusion Solution Bag; 0.9% saline as distension medium as long as diathermy is not in use
Placebo Comparator: 1.5% GLYCINE; 1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use	Drug: 1.5% Glycine only; 1.5% Glycine alone during hysteroscopy as long as diathermy is in use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Systolic Blood Pressure	Non-invasive blood pressure measurement by using sphygmomanometer cuff	data will be collected over 24 hours from the beginning of the procedure

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: AHMED sonbaty, doctor, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2018
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: May 13, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 25, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2022
• Last Update Submitted That Met QC Criteria: July 1, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Glycine Agents; Glycine
• Other Study ID Numbers: ahmed 2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No