The Impact of Anesthesia on the Absorpt… | Clinical Trial

Key information

Conditions

The Absorption of Glycine in Operative Hysteroscopy

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire de Québec

Québec, Quebec, G1V 4G2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Midazolam, Sufentanil, Propofol, Rocuronium, Sevoflurane, Ephedrine

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.

Other names: Lidocaine, Midazolam, Sufentanil, Propofol

Primary outcomes

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.

Secondary outcomes

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).
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.
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.
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.
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?".
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

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Collaborators

Association of Professors of Obstetrics and Gynaecology of Canada

Registry information

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: May 17, 2010
Registry last updated: May 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.