NCT01124383

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 95 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• The Absorption of Glycine in Operative Hysteroscopy

Interventions

Type	Name	Description
PROCEDURE	General anesthesia	For women in the general anesthesia group, general anesthesia is induced using midazolam 1-3 mg, sufentanil 0.15-0.25 mcg/kg and propofol 1-3 mg/kg. Rocuronium 0.6 mg/kg is allowed. Anesthesia is maintained with sevoflurane titrated to maintain a blood pressure within 20% of preoperative normal and, if needed, ephedrine can be used for this purpose. Patients are ventilated in a normocapnic range with a positive end-expiratory pressure of 3 to 5 mmHg.
PROCEDURE	Local anesthesia with sedation	For women in the local anesthesia group a paracervical block is performed by the gynecologist using a total of 20 mL of 1% lidocaine intracervically at 2, 4, 7 and 10 o'clock positions and in the area of uterosacral ligaments. Once the block completed, the surgeon waits at least five minutes before performing cervical dilatation to allow for sufficient analgesia. Intravenous sedation consists of midazolam, sufentanil and propofol administered by the anesthesiologist in sufficient doses to maintain a spontaneous ventilation with a Ramsay score \< 4.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2010-05-17
• Last updated: 2010-05-17

Locations

1 site across 1 country: Canada