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

May 13, 2010 updated by: CHU de Quebec-Universite Laval
This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine in operative hysteroscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 4G2
        • Centre Hospitalier Universitaire de Quebec

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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:
  • Sufentanil
  • Midazolam
  • Rocuronium
  • Sevoflurane
  • Propofol
  • 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
  • Sufentanil
  • Midazolam
  • Propofol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
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.
Assessed between 1 minute and 20 minutes after the end of surgery
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.
Assessed the same day of surgery (no more than 6 hours after surgery)
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.
Assessed the same day of surgery (no more than 6 hours after surgery)
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?".
Assessed on postoperative day one. In average 24 hours after surgery.
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
Assessed on postoperative day one. In average 24 hours after surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHU de Quebec-Universite Laval

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 17, 2010

Study Record Updates

Last Update Posted (Estimate)

May 17, 2010

Last Update Submitted That Met QC Criteria

May 13, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUQ: 118.05.07
  • CHA: CER-019-001 (Other Identifier: Centre Hospitalier Universitaire Affilié de Québec)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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