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

Laval University

Status: Completed

Conditions: The Absorption of Glycine in Operative Hysteroscopy

Treatments: Procedure: Local anesthesia with sedation; Procedure: General anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01124383

CHA: CER-019-001 (Other Identifier)

CHUQ: 118.05.07

Details and patient eligibility

About

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

Full 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.

Enrollment: 95 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

General anesthesia

Active Comparator group

Treatment:

Procedure: General anesthesia

Local anesthesia with sedation

Active Comparator group

Treatment:

Procedure: Local anesthesia with sedation