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

NCT ID: NCT04328870

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-20

Study Completion Date

2019-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Fluid Overload

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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oxytocin and spinal anesthesia

spinal anesthesia combined with intravenous oxytocin infusion

Group Type ACTIVE_COMPARATOR

oxytocin and spinal anesthesia

Intervention Type OTHER

start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia

general anesthsia

general anesthesia alone

Group Type ACTIVE_COMPARATOR

General anesthsia

Intervention Type OTHER

General anesthesia alone.

Interventions

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oxytocin and spinal anesthesia

start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia

Intervention Type OTHER

General anesthsia

General anesthesia alone.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Jordan

OTHER

Sponsor Role lead

Responsible Party

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Naser Al-Husban

Assistant Professor and Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Abdelkarim ALoweidi, consultant

Role: STUDY_DIRECTOR

jordan university

Locations

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University of Jordan

Amman, , Jordan

Site Status

Countries

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Jordan

Other Identifiers

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IORG0007981

Identifier Type: -

Identifier Source: org_study_id