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

This study has been completed.
Sponsor:
Collaborator:
Association of Professors of Obstetrics and Gynaecology of Canada
Information provided by:
Centre Hospitalier Universitaire de Québec, CHU de Québec
ClinicalTrials.gov Identifier:
NCT01124383
First received: April 13, 2010
Last updated: May 13, 2010
Last verified: April 2010
  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

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Québec, CHU de Québec:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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:
  • General anesthesia
  • Midazolam
  • Sufentanil
  • Propofol
  • Rocuronium
  • Sevoflurane
  • Ephedrine
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:
  • Lidocaine
  • Midazolam
  • Sufentanil
  • Propofol

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
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01124383

Locations
Canada, Quebec
Centre Hospitalier Universitaire de Québec
Québec, Quebec, Canada, G1V 4G2
Sponsors and Collaborators
Centre Hospitalier Universitaire de Québec, CHU de Québec
Association of Professors of Obstetrics and Gynaecology of Canada
Investigators
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 July 24, 2014