Clinical trial NCT01124383: The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
Official title: The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Absorption of Glycine in Operative Hysteroscopy
Keywords: Glycine absorption
Operative hysteroscopy
Endometrial resection
General anesthesia
Local anesthesia
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: Association of Professors of Obstetrics and Gynaecology of Canada
First posted: 2010-05-17
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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

Primary outcomes:
measure: Median absorption of glycine (10th-90th centile)
timeFrame: The absorption of glycine is measured between time of the introduction of the resectoscope and its final withdrawal. Assessed between 1 minute and 20 minutes after the end of surgery
Secondary outcomes:
measure: Absorption of glycine greater than 1000 mL
timeFrame: The absorption of glycine is measured between time of the introduction of the resectoscope and its final withdrawal. Assessed between 1 minute and 20 minutes after the end of surgery
measure: Discontinuation of surgery because of excessive absorption.
timeFrame: Assessed between 1 minute and 20 minutes after the end of surgery
measure: Difference of natremia pre and post-procedure
timeFrame: Assessed the same day of surgery (no more than 6 hours after surgery)
measure: Postoperative severe hyponatremia
timeFrame: Assessed the same day of surgery (no more than 6 hours after surgery)
measure: Patient's satisfaction towards the type of anesthesia
timeFrame: Assessed on postoperative day one. In average 24 hours after surgery.
measure: Quality of life and recovery
timeFrame: Assessed on postoperative day one. In average 24 hours after surgery.
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec
state: Quebec
Study officials:
affiliation: Centre hospitalier universitaire de Québec- Université Laval
name: Emmanuel Bujold, MD MSc FRCSC
role: STUDY_CHAIR
affiliation: Centre hospitalier universitaire de Québec- Université Laval
name: Marie-Eve Bergeron, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre hospitalier universitaire de Québec- Université Laval
name: Pascale Ouellet, MD
role: PRINCIPAL_INVESTIGATOR
References: