The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT01124383|
Recruitment Status : Completed
First Posted : May 17, 2010
Last Update Posted : May 17, 2010
|Condition or disease||Intervention/treatment||Phase|
|The Absorption of Glycine in Operative Hysteroscopy||Procedure: General anesthesia Procedure: Local anesthesia with sedation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
|Active Comparator: General anesthesia||
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.
|Active Comparator: Local anesthesia with sedation||
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.
- Median absorption of glycine (10th-90th centile) [ Time Frame: 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.
- Absorption of glycine greater than 1000 mL [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Patient's satisfaction towards the type of anesthesia [ Time Frame: 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?".
- Quality of life and recovery [ Time Frame: Assessed on postoperative day one. In average 24 hours after surgery. ]8-item Short-Form Health Survey (SF-8) standardized questionnaire
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124383
|Centre Hospitalier Universitaire de Québec|
|Québec, Quebec, Canada, G1V 4G2|
|Study Chair:||Emmanuel Bujold, MD MSc FRCSC||Centre Hospitalier Universitaire de Québec, Université Laval|
|Principal Investigator:||Marie-Eve Bergeron, MD||Centre Hospitalier Universitaire de Québec, Université Laval|
|Principal Investigator:||Pascale Ouellet, MD||Centre Hospitalier Universitaire de Québec, Université Laval|