The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine in operative hysteroscopy.
| Condition | Intervention |
|---|---|
|
The Absorption of Glycine in Operative Hysteroscopy |
Procedure: General anesthesia Procedure: Local anesthesia with sedation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial |
- 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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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) ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]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. ] [ Designated as safety issue: No ]8-item Short-Form Health Survey (SF-8) standardized questionnaire
| Enrollment: | 95 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
Other Names:
|
| 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.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts 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
Contacts and Locations| Canada, Quebec | |
| 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 |
More Information
No publications provided
| Responsible Party: | Marie-Eve Bergeron MD, Centre Hospitalier Universitaire de Québec, Université Laval |
| ClinicalTrials.gov Identifier: | NCT01124383 History of Changes |
| Other Study ID Numbers: | CHUQ: 118.05.07, CHA: CER-019-001 |
| Study First Received: | April 13, 2010 |
| Last Updated: | May 13, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:
|
Glycine absorption Operative hysteroscopy Endometrial resection General anesthesia Local anesthesia |
Additional relevant MeSH terms:
|
Anesthetics Midazolam Lidocaine Propofol Sevoflurane Sufentanil Ephedrine Glycine Rocuronium Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Adjuvants, Anesthesia |
Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Vasoconstrictor Agents |
ClinicalTrials.gov processed this record on May 16, 2013