Hemodynamic Changes During Operative Hysteroscopy
Primary Purpose
Hypertension
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Normal Saline 0.9% Infusion Solution Bag
1.5% Glycine only
Sponsored by

About this trial
This is an interventional prevention trial for Hypertension
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.
Sites / Locations
- Assiut University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
normal saline0.9%
1.5% GLYCINE
Arm Description
0.9% saline distension media is used as long as diathermy is not in use
1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use
Outcomes
Primary Outcome Measures
Change from Baseline Systolic Blood Pressure
Non-invasive blood pressure measurement by using sphygmomanometer cuff
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03166228
Brief Title
Hemodynamic Changes During Operative Hysteroscopy
Official Title
Hematological, Biochemical and Hemodynamic Changes During Operative Hysteroscopy Using Consecutive Distension Media
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2018 (Actual)
Primary Completion Date
June 17, 2022 (Actual)
Study Completion Date
June 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
normal saline0.9%
Arm Type
Active Comparator
Arm Description
0.9% saline distension media is used as long as diathermy is not in use
Arm Title
1.5% GLYCINE
Arm Type
Placebo Comparator
Arm Description
1.5% GLYCINE DURING OPERATIVE HYSTEROSCOPY as long as diathermy is in use
Intervention Type
Drug
Intervention Name(s)
Normal Saline 0.9% Infusion Solution Bag
Intervention Description
0.9% saline as distension medium as long as diathermy is not in use
Intervention Type
Drug
Intervention Name(s)
1.5% Glycine only
Intervention Description
1.5% Glycine alone during hysteroscopy as long as diathermy is in use
Primary Outcome Measure Information:
Title
Change from Baseline Systolic Blood Pressure
Description
Non-invasive blood pressure measurement by using sphygmomanometer cuff
Time Frame
data will be collected over 24 hours from the beginning of the procedure
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
FEMALE IN THE REPRODUCTIVE AGE (20-40 YEARS)
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AHMED sonbaty, doctor
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut University
City
Assiut
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Changes During Operative Hysteroscopy
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