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NCT04328870 Clinical Trial

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

Fluid Overload Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04328870
Other study ID # IORG0007981
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2018
Est. completion date September 30, 2019

Study information
Verified date March 2020
Source University of Jordan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 88
Est. completion date September 30, 2019
Est. primary completion date September 30, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 49 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• oxytocin and spinal anesthesia
start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia
• General anesthsia
General anesthesia alone.

Locations
Country Name City State
Jordan University of Jordan Amman

Sponsors (1)
Lead Sponsor Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome
Type Measure Description Time frame Safety issue
Primary fluid overload Fluid (glycine) excessive absorption into the patient 16 months
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