Hemodynamic Changes During Operative Hysteroscopy

NCT03166228 | Completed Phase 2

• 1 other identifier: ahmed 2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

normal saline0.9%

ACTIVE COMPARATOR

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

Drug: Normal Saline 0.9% Infusion Solution Bag

1.5% GLYCINE

PLACEBO COMPARATOR

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

Drug: 1.5% Glycine only

Interventions

Normal Saline 0.9% Infusion Solution Bag DRUG

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

normal saline0.9%

1.5% Glycine only DRUG

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

1.5% GLYCINE

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: FEMALE IN THE REPRODUCTIVE AGE (20-40 YEARS)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, Egypt

Location

MeSH Terms

Conditions

Hypertension

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• AHMED sonbaty, doctor

  Assiut University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: May 13, 2017
• First Posted: May 25, 2017
• Study Start: January 5, 2018
• Primary Completion: June 17, 2022
• Study Completion: June 17, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-07

Locations

EG (1)