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The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial

Information source: Centre Hospitalier Universitaire de Quťbec, CHU de Quťbec
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: The Absorption of Glycine in Operative Hysteroscopy

Intervention: General anesthesia (Procedure); Local anesthesia with sedation (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Centre Hospitalier Universitaire de Quťbec, CHU de Quťbec

Official(s) and/or principal investigator(s):
Emmanuel Bujold, MD MSc FRCSC, Study Chair, Affiliation: Centre Hospitalier Universitaire de Québec, Université Laval
Marie-Eve Bergeron, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire de Québec, Université Laval
Pascale Ouellet, MD, Principal Investigator, Affiliation: Centre Hospitalier Universitaire de Québec, Université Laval

Summary

This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine in operative hysteroscopy.

Clinical Details

Official title: The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Median absorption of glycine (10th-90th centile)

Secondary outcome:

Absorption of glycine greater than 1000 mL

Discontinuation of surgery because of excessive absorption.

Difference of natremia pre and post-procedure

Postoperative severe hyponatremia

Patient's satisfaction towards the type of anesthesia

Quality of life and recovery

Detailed description: As a minimally invasive procedure, operative hysteroscopy has gained popularity in the past two decades and became a standard surgical treatment for abnormal uterine bleeding unresponsive to medical management. Despite its increasing use, little information is known on the predictors of its potential complications. The absorption of glycine has been reported as the most common complication of this procedure and it remains an unpredictable complication that may lead to life-threatening conditions. This randomized controlled trial is conducted in two centers: a tertiary care center and in a community hospital over a period of 18 months. This study aimed to compare two types of anesthesia on the absorption of glycine in operative hysteroscopy. Eligible patients undergoing operative hysteroscopy for abnormal uterine bleeding are randomized in two groups: group general anesthesia and group local anesthesia with sedation.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Abnormal uterine bleeding with clinical indication for operative hysteroscopy

according to an obstetrician-gynecologist.

- American Society of Anesthesia (ASA) class 1 or 2

Exclusion Criteria:

- Any contraindications to hysteroscopy (suspicion of pelvic or vaginal-cervical

infection, severe hemorrhage, pregnancy, suspicion of neoplasia and previous uterine perforation)

- ASA class 3 or more

- Women who had a previous endometrial resection

- Diabetic patients

- Women requiring a predetermined type of anesthesia because of a specific medical

condition

Locations and Contacts

Centre Hospitalier Universitaire de Québec, Québec, Quebec G1V 4G2, Canada
Additional Information

Starting date: August 2008
Last updated: May 13, 2010

Page last updated: August 23, 2015

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