Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study

March 30, 2020 updated by: Naser Al-Husban, University of Jordan

The Impact of Spinal Anesthesia and Use of Oxytocin on Fluid Absorption in Patients Undergoing Operative Hysteroscopy; Results From a Prospective Controlled Study

To determine if combining intravenous oxytocin infusion and spinal anesthesia will reduce the amount of glycine absorption in patients undergoing operative hysteroscopy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective controlled study in premenopausal patients who had hysteroscopic surgery including endometrial resection, endometrial polypectomy, myomectomy resection and uterine septal resection. The effect of combined spinal anesthetic with oxytocin infusion on fluid deficit was studied.

Study Type

Interventional

Enrollment (Actual)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • University of Jordan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • premenopausal with no cardiovascular comorbidities

Exclusion Criteria:

  • endometrial cancer cases, patients who received pre-operative hormonal preparations, previously resected cases and cases done using bipolar diathermy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: oxytocin and spinal anesthesia
spinal anesthesia combined with intravenous oxytocin infusion
Other: oxytocin and spinal anesthesia
start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia
Active Comparator: general anesthsia
general anesthesia alone
Other: General anesthsia
General anesthesia alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
fluid overload
Time Frame: 16 months
Fluid (glycine) excessive absorption into the patient
16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Jordan

Investigators

  • Study Director: Abdelkarim ALoweidi, consultant, Jordan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2018

Primary Completion (Actual)

September 30, 2019

Study Completion (Actual)

September 30, 2019

Study Registration Dates

First Submitted

March 25, 2020

First Submitted That Met QC Criteria

March 30, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IORG0007981

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

on reasonable request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fluid Overload

Clinical Trials on oxytocin and spinal anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Myanmar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe