The Absorption of Glycine in Operative HysteroscopyNCT01124383
The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
A study testing General anesthesia and Local anesthesia with sedation in people with The Absorption of Glycine in Operative Hysteroscopy, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- The Absorption of Glycine in Operative Hysteroscopy
- What is being tested?
- General anesthesia and Local anesthesia with sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abnormal uterine bleeding with clinical indication for operative hysteroscopy according to an obstetrician-gynecologist.
- American Society of Anesthesia (ASA) class 1 or 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1V 4G2
About this study
This study aimed to compare two types of anesthesia (general anesthesia and local anesthesia with sedation) on the absorption of glycine in operative hysteroscopy.
Read the 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.
- Being tested
- General anesthesia, Local anesthesia with sedation
- Keywords
- Glycine absorption, Operative hysteroscopy, Endometrial resection, General anesthesia, Local anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaProcedure or surgery
Also called Midazolam, Sufentanil, Propofol, Rocuronium
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 sedationProcedure or surgery
Also called Lidocaine, Midazolam, Sufentanil, Propofol
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.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Active comparator | Not described Receives: Procedure: General anesthesia |
| Local anesthesia with sedation | Active comparator | Not described Receives: Procedure: Local anesthesia with sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median absorption of glycine (10th-90th centile)
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.
Measured: 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 outcomes (6)
Absorption of glycine greater than 1000 mL
The total absorption of glycine is measured by an automated surgical irrigator (tandem canister: Equimat and Endomat; Karl Storz Endoscopy, Tuttlingen, Germany).
Measured: 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.
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.
Measured: Assessed between 1 minute and 20 minutes after the end of surgery
Difference of natremia pre and post-procedure
In the hour preceeding the surgery and in the hour following surgery, natremia will be measured in the patient serum.
Measured: Assessed the same day of surgery (no more than 6 hours after surgery)
Postoperative severe hyponatremia
Defined as a patient's natremia below 125 meq/L in the first postoperative hour.
Measured: Assessed the same day of surgery (no more than 6 hours after surgery)
Patient's satisfaction towards the type of anesthesia
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?".
Measured: Assessed on postoperative day one. In average 24 hours after surgery.
Quality of life and recovery
8-item Short-Form Health Survey (SF-8) standardized questionnaire
Measured: Assessed on postoperative day one. In average 24 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2010 (estimated)
- Study startAug 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Absorption of Glycine in Operative HysteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Association of Professors of Obstetrics and Gynaecology of Canada
- Investigators
- Emmanuel Bujold, MD MSc FRCSC, Study chair, CHU de Quebec-Universite LavalMarie-Eve Bergeron, MD, Principal investigator, CHU de Quebec-Universite LavalPascale Ouellet, MD, Principal investigator, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124383
- Sponsor's protocol ID
- CHUQ: 118.05.07
- Other IDs
- CHA: CER-019-001
- Status last verified
- Apr 2010
- First submitted
- 13 Apr 2010
- Last updated
- 17 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Anesthesia on the Absorption of Glycine in Operative Hysteroscopy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01124383
- Acronym / sponsor ID
- CHUQ: 118.05.07
- Keywords
- Glycine absorption, Operative hysteroscopy, Endometrial resection, General anesthesia, Local anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Association of Professors of Obstetrics and Gynaecology of Canada
- Study start
- Aug 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 17 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Active comparator | Procedure: General anesthesia |
| Local anesthesia with sedation | Active comparator | Procedure: Local anesthesia with sedation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Abnormal uterine bleeding with clinical indication for operative hysteroscopy according to an obstetrician-gynecologist.
- American Society of Anesthesia (ASA) class 1 or 2
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesiaAlso: Midazolam, Sufentanil, Propofol, RocuroniumFor 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. | Procedure or surgery | General anesthesia |
| Local anesthesia with sedationAlso: Lidocaine, Midazolam, Sufentanil, PropofolFor 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. | Procedure or surgery | Local anesthesia with sedation |
Primary outcome
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.
6 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
Discontinuation of surgery because of excessive absorption.
Time frame: 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)
Postoperative severe hyponatremia
Time frame: 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.
Quality of life and recovery
Time frame: Assessed on postoperative day one. In average 24 hours after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Bujold, MD MSc FRCSC study chair
CHU de Quebec-Universite Laval
Marie-Eve Bergeron, MD principal investigator
CHU de Quebec-Universite Laval
Pascale Ouellet, MD principal investigator
CHU de Quebec-Universite Laval
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia and Local anesthesia with sedation in people with The Absorption of Glycine in Operative Hysteroscopy, run by CHU de Quebec-Universite Laval at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2010.