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

Study Overview
=================
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.

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

Conditions
-----------------
The Absorption of Glycine in Operative Hysteroscopy

Intervention / Treatment
-----------------
* Procedure: General anesthesia
* Procedure: Local anesthesia with sedation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: General anesthesia<br> | Procedure: General anesthesia<br>* 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.<br>* Other names: Ephedrine;|
| Active Comparator: Local anesthesia with sedation<br> | Procedure: Local anesthesia with sedation<br>* 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.<br>* Other names: Propofol;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median absorption of glycine (10th-90th centile) | 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absorption of glycine greater than 1000 mL | The total absorption of glycine is measured by an automated surgical irrigator (tandem canister: Equimat and Endomat; Karl Storz Endoscopy, Tuttlingen, Germany). | 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 | 
| Discontinuation of surgery because of excessive absorption. | 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. | Assessed between 1 minute and 20 minutes after the end of surgery | 
| Difference of natremia pre and post-procedure | In the hour preceeding the surgery and in the hour following surgery, natremia will be measured in the patient serum. | Assessed the same day of surgery (no more than 6 hours after surgery) | 
| Postoperative severe hyponatremia | Defined as a patient's natremia below 125 meq/L in the first postoperative hour. | Assessed the same day of surgery (no more than 6 hours after surgery) | 
| Patient's satisfaction towards the type of anesthesia | 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?. | Assessed on postoperative day one. In average 24 hours after surgery. | 
| Quality of life and recovery | 8-item Short-Form Health Survey (SF-8) standardized questionnaire | Assessed on postoperative day one. In average 24 hours after surgery. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glycine absorption, Operative hysteroscopy, Endometrial resection, General anesthesia, Local anesthesia