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

NCT ID: NCT01124383

Last Updated: 2010-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-02-28

Brief Summary

This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine in operative hysteroscopy.

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.

Conditions

The Absorption of Glycine in Operative Hysteroscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

General anesthesia

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: 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.

Local anesthesia with sedation

Group Type: ACTIVE_COMPARATOR

Local anesthesia with sedation

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Midazolam; Sufentanil; Propofol; Rocuronium; Sevoflurane; Ephedrine; Lidocaine; Midazolam; Sufentanil; Propofol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Association of Professors of Obstetrics and Gynaecology of Canada

OTHER

Sponsor Role: collaborator

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: lead

Responsible Party

Centre Hospitalier Universitaire de Québec, Université Laval

Principal Investigators

Emmanuel Bujold, MD MSc FRCSC

Role: STUDY_CHAIR

Centre hospitalier universitaire de Québec- Université Laval

Marie-Eve Bergeron, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier universitaire de Québec- Université Laval

Pascale Ouellet, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier universitaire de Québec- Université Laval

Locations

Centre Hospitalier Universitaire de Québec

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

CHA: CER-019-001

Identifier Type: OTHER

Identifier Source: secondary_id

CHUQ: 118.05.07

Identifier Type: -

Identifier Source: org_study_id