Uterine CurettageEDAUCNCT00733564
Evaluation of Different Anesthesia for Uterine Curettage
A study testing Lidocaine, Propofol and Sevoflurane in people with Uterine Curettage and Abortion, Induced, run by Nanjing Medical University at 1 site in China.
Trial summary
Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Uterine Curettage, Abortion, Induced
- What is being tested?
- Lidocaine, Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Aug 2008to Mar 2009
- 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 19 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA status I-II
- Performing abortion operation (medical- or surgical)
- Requiring painless abortion
Who cannot join
- < 19 yrs, and >=45 yrs
- History of central active drugs administration
- Drug abuse
- Hypertension
- Diabetes
- Any other chronic diseases
Show all 10Show fewer
- Allergy to the study drugs
- Habit of over-volume alcohol drinking
- Records of history of centrally active drug use and psychiatry
- Any organic disorder
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Maternal and Child Health Care Hospital
Nanjing, Jiangsu, 210004
About this study
Official title: Evaluation of the Anesthetic Efficacy of Propofol,Sevoflurane and Paracervical Block for Uterine Curettage
Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators hypothesized that propofol, sevoflurane and paracervical block had different anesthetic efficacy during uterine curettage. Which one is the optimal selection for such operation needed to be evaluated.
- Conditions
- Uterine Curettage, Abortion, Induced
- Being tested
- Lidocaine, Propofol, Sevoflurane
- Keywords
- Local anesthetic, Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called Lignocaine
Paracervical injection of 2% Lidocaine to block associated nociception input
PropofolDrug
Also called Diprivan
Propofol 3mg/kg will be injected intravenously; 1 mg/kg will be added additionally for incomplete anesthesia
SevofluraneDrug
Also called Sevorane
Sevoflurane 8% for anesthesia induction, 2-3% as the maintenance
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Paracervical block will be performed Receives: Drug: Lidocaine |
| 2 | Experimental | Propofol anesthesia will be performed Receives: Drug: Propofol |
| 3 | Experimental | Sevoflurane anesthesia will be performed Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bispectral Index (BIS) value
Measured: 0, 5, 10, 20, 30min after anesthesia
Secondary outcomes (7)
Intraoperative awareness
Measured: 0, 5, 10, 20, 30min after anesthesia
Vital signs
Measured: 0, 5, 10, 15, 20, 25, 30min after anesthesia
Arterial blood gas analysis
Measured: 5min before operation; 1min and 5min after beginning of the operation
Pain intensity
Measured: 0, 5, 10, 20, 30min after surgical procedures
Cortisol level
Measured: 30min before operation; 1 and 5min during operation
Side effects
Measured: 30min after operation
Uterine bleeding
Measured: 0min after completion of the operation; 1 hour after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CurettageStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study director, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733564
- Sponsor's protocol ID
- NMU-FY2008-209
- Other IDs
- NJFY0890-MZ12
- Acronym
- EDAUC
- Status last verified
- Mar 2009
- First submitted
- 11 Aug 2008
- Last updated
- 31 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anesthetic Efficacy of Propofol,Sevoflurane and Paracervical Block for Uterine Curettage
- ClinicalTrials.gov ID
- NCT00733564
- Acronym / sponsor ID
- EDAUC / NMU-FY2008-209
- Conditions
- Uterine Curettage, Abortion, Induced
- Keywords
- Local anesthetic, Propofol, Sevoflurane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 13 Aug 2008 (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.
Anesthesia during uterine curettage is a problem. Paracervical block is used in general for such an operation, though, the anesthetic efficacy is incomplete. Propofol is the short-lasting intravenous anesthetic administrated popularly. Sevoflurane is a new inhalational anesthetic well-known for it's "easy come, easy go" property. The investigators hypothesized that propofol, sevoflurane and paracervical block had different anesthetic efficacy during uterine curettage. Which one is the optimal selection for such operation needed to be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: LidocaineParacervical block will be performed |
| 2 | Experimental | Drug: PropofolPropofol anesthesia will be performed |
| 3 | Experimental | Drug: SevofluraneSevoflurane anesthesia will be performed |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA status I-II
- Performing abortion operation (medical- or surgical)
- Requiring painless abortion
Key exclusion criteria (10 listed)
- < 19 yrs, and >=45 yrs
- History of central active drugs administration
- Drug abuse
- Hypertension
- Diabetes
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 |
|---|---|---|
| LidocaineAlso: LignocaineParacervical injection of 2% Lidocaine to block associated nociception input | Drug | 1 |
| PropofolAlso: DiprivanPropofol 3mg/kg will be injected intravenously; 1 mg/kg will be added additionally for incomplete anesthesia | Drug | 2 |
| SevofluraneAlso: SevoraneSevoflurane 8% for anesthesia induction, 2-3% as the maintenance | Drug | 3 |
Primary outcome
Bispectral Index (BIS) value
Time frame: 0, 5, 10, 20, 30min after anesthesia
7 secondary outcomes
Intraoperative awareness
Time frame: 0, 5, 10, 20, 30min after anesthesia
Vital signs
Time frame: 0, 5, 10, 15, 20, 25, 30min after anesthesia
Arterial blood gas analysis
Time frame: 5min before operation; 1min and 5min after beginning of the operation
Pain intensity
Time frame: 0, 5, 10, 20, 30min after surgical procedures
Cortisol level
Time frame: 30min before operation; 1 and 5min during operation
Side effects
Time frame: 30min after operation
Uterine bleeding
Time frame: 0min after completion of the operation; 1 hour after the operation
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 31 Mar 2009.
Related trials for Uterine Curettage
Active, not recruiting
Comparison of Manual Vacuum Aspiration and Dilatation and Curettage for Endometrial Sampling Adequacy in Women With Abnormal Uterine Bleeding
Abnormal Uterine Bleeding
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.
XiaoFeng Shen, MD study director
Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine, Propofol and Sevoflurane in people with Uterine Curettage and Abortion, Induced, run by Nanjing Medical University at 1 site in China.
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 3 inclusion and 10 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 31 Mar 2009. 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 China. 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?
Bispectral Index (BIS) value (time frame: 0, 5, 10, 20, 30min after anesthesia). 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 31 Mar 2009.