The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
- Conditions
- The Absorption of Glycine in Operative Hysteroscopy
- Interventions
- Procedure: General anesthesiaProcedure: Local anesthesia with sedation
- Registration Number
- NCT01124383
- Lead Sponsor
- CHU de Quebec-Universite Laval
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 95
- Abnormal uterine bleeding with clinical indication for operative hysteroscopy according to an obstetrician-gynecologist.
- American Society of Anesthesia (ASA) class 1 or 2
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description General anesthesia General anesthesia - Local anesthesia with sedation Local anesthesia with sedation -
- Primary Outcome Measures
Name Time Method Median absorption of glycine (10th-90th centile) 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 The primary outcome is the median absorption of glycine (10th-90th centile). The glycine absorption is measured by an automated surgical irrigator (tandem canister: Equimat and Endomat; Karl Storz Endoscopy, Tuttlingen, Germany) and it represent the difference between the input and the output of glycine used for the irrigation of the uterine cavity.
- Secondary Outcome Measures
Name Time Method Patient's satisfaction towards the type of anesthesia Assessed on postoperative day one. In average 24 hours after surgery. Patient's satisfaction toward their anesthesia was evaluated by the following yes or no question: "If you had to undergo the same surgery, would you choose the same type of anesthesia?".
Absorption of glycine greater than 1000 mL 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 The total absorption of glycine is measured by an automated surgical irrigator (tandem canister: Equimat and Endomat; Karl Storz Endoscopy, Tuttlingen, Germany).
Discontinuation of surgery because of excessive absorption. Assessed between 1 minute and 20 minutes after the end of surgery Left at the discretion of the surgeon and anesthesiologist. However, according to the guidelines of the ACOG and the AAGL, it is recommended to stop the surgery when the glycine deficit exceeds 1000-1500 mL. Therefore, the surgeon who is blinded to the absorption rate will be informed when it reachs 500 and 1000 mL.
Difference of natremia pre and post-procedure Assessed the same day of surgery (no more than 6 hours after surgery) In the hour preceeding the surgery and in the hour following surgery, natremia will be measured in the patient serum.
Postoperative severe hyponatremia Assessed the same day of surgery (no more than 6 hours after surgery) Defined as a patient's natremia below 125 meq/L in the first postoperative hour.
Quality of life and recovery Assessed on postoperative day one. In average 24 hours after surgery. 8-item Short-Form Health Survey (SF-8) standardized questionnaire
Trial Locations
- Locations (1)
Centre Hospitalier Universitaire de Québec
🇨🇦Québec, Quebec, Canada