The Absorption of Glycine in Operative Hysteroscopy
Conditions
Keywords
Glycine absorption, Operative hysteroscopy, Endometrial resection, General anesthesia, Local anesthesia
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.
Interventions
PROCEDUREGeneral 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.
PROCEDURELocal 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.
Sponsors
Association of Professors of Obstetrics and Gynaecology of Canada
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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). |
| 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?. |
| 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 |
| 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. |
Countries
Canada
Outcome results
None listed