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| ID | Type | Description | Link |
|---|---|---|---|
| CHA: CER-019-001 | Other Identifier | Centre Hospitalier Universitaire Affilié de Québec |
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| Name | Class |
|---|---|
| Association of Professors of Obstetrics and Gynaecology of Canada | OTHER |
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This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine in operative hysteroscopy.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General anesthesia | Active Comparator |
| |
| Local anesthesia with sedation | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General anesthesia | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Bujold, MD MSc FRCSC | CHU de Quebec-Universite Laval | Study Chair |
| Marie-Eve Bergeron, MD | CHU de Quebec-Universite Laval | Principal Investigator |
| Pascale Ouellet, MD | CHU de Quebec-Universite Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Québec | Québec | Quebec | G1V 4G2 | Canada |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D008874 | Midazolam |
| D017409 | Sufentanil |
| D015742 | Propofol |
| D000077123 | Rocuronium |
| D000077149 | Sevoflurane |
| D004809 | Ephedrine |
| D000772 | Anesthesia, Local |
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
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| Local anesthesia with sedation | Procedure | 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. |
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| 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. |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D000732 | Androstanols |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008738 | Methyl Ethers |
| D004987 | Ethers |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D020005 | Propanols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000765 | Anesthesia, Conduction |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |