AbortionPhase 4PABADUCNCT00795314
Propofol-butorphanol Anesthesia During Uterine Curettage
A Phase 4 study testing Fentanyl Citrate and Butorphanol Tartrate in people with Abortion and Curettage, run by Nanjing Medical University at 1 site in China.
Trial summary
Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or para-cervical block,of which generally has significant incidence of respiratory depression which increases the demand on intraoperative monitoring, or has unavoidable insufficient blockade which results in intraoperative suffering of… Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- What is being tested?
- Fentanyl Citrate and Butorphanol Tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Jul 2009
- Phase
- Phase 4
- 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 drug-induced);
- Requiring painless abortion;
Who cannot join
- < 19yrs, and >= 45yrs;
- History of central active drugs administration;
- Drug abuse;
- Hypertension;
- Diabetes;
- Any other chronic diseases;
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- Allergy to the study drugs;
- Habit of over-volume alcohol drinking;
- Records of history of centrally active drug use and psychiatry;
- Any organic disorders.
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: Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion
Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or para-cervical block,of which generally has significant incidence of respiratory depression which increases the demand on intraoperative monitoring, or has unavoidable insufficient blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with combined effects on mu and kappa opioid receptors leading to a role as analgesia and sedation. The investigators hypothesized that combined propofol with butorphanol during uterine curettage would produce optimal effectiveness of these two drugs by adding sedative and analgesic effects together. In addition, it would decrease the intraoperative consumption of propofol without increase the incidence of side effects. Furthermore, such combination would alleviate postoperative pain.
- Being tested
- Fentanyl Citrate, Butorphanol Tartrate
- Keywords
- Opioids, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl CitrateDrug
Also called Actiq®, Fentora TM, Duragesic®
Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg)
Butorphanol TartrateDrug
Also called Torbugesic®, Torbutrol®
Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Propofol-fentanyl combined anesthesia Receives: Drug: Fentanyl Citrate |
| 2 | Experimental | Propofol-butorphanol combined anesthesia Receives: Drug: Butorphanol Tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative awareness
Measured: During the whole process of anesthesia
Secondary outcomes (4)
Bispectral Index (BIS) value
Measured: During the whole process of anesthesia
Anesthetic consumptions
Measured: From the start of operation to the end of surgical procedures
Postoperative pain
Measured: Since the end of the operation to 48 h follow-up.
Postoperative bleeding
Measured: Since the end of operation to 48 h follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AbortionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Investigators
- XiaoFeng Shen, MD, Study chair, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795314
- Sponsor's protocol ID
- NMU-2008-FY10MZ31
- Other IDs
- NJFY0811-MZ02
- Acronym
- PABADUC
- Status last verified
- Jul 2009
- First submitted
- 20 Nov 2008
- Last updated
- 15 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Propofol-butorphanol Combined Anesthesia During Uterine Curettage on Abortion
- ClinicalTrials.gov ID
- NCT00795314
- Acronym / sponsor ID
- PABADUC / NMU-2008-FY10MZ31
- Keywords
- Opioids, General anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 Nov 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.
Uterine curettage is usually performed under the anesthesia of propofol-fentanyl or para-cervical block,of which generally has significant incidence of respiratory depression which increases the demand on intraoperative monitoring, or has unavoidable insufficient blockade which results in intraoperative suffering of pain. Butorphanol is an analgesic with combined effects on mu and kappa opioid receptors leading to a role as analgesia and sedation. The investigators hypothesized that combined propofol with butorphanol during uterine curettage would produce optimal effectiveness of these two drugs by adding sedative and analgesic effects together. In addition, it would decrease the intraoperative consumption of propofol without increase the incidence of side effects. Furthermore, such combination would alleviate postoperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Fentanyl CitratePropofol-fentanyl combined anesthesia |
| 2 | Experimental | Drug: Butorphanol TartratePropofol-butorphanol combined anesthesia |
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 drug-induced);
- Requiring painless abortion;
Key exclusion criteria (10 listed)
- < 19yrs, and >= 45yrs;
- 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 |
|---|---|---|
| Fentanyl CitrateAlso: Actiq®, Fentora TM, Duragesic®Combined anesthesia with propofol (2-2.5mg/kg) and fentanyl (5 μg) | Drug | 1 |
| Butorphanol TartrateAlso: Torbugesic®, Torbutrol®Combined anesthesia with propofol (2-2.5 mg/kg) and butorphanol (1mg) | Drug | 2 |
Primary outcome
Intraoperative awareness
Time frame: During the whole process of anesthesia
4 secondary outcomes
Bispectral Index (BIS) value
Time frame: During the whole process of anesthesia
Anesthetic consumptions
Time frame: From the start of operation to the end of surgical procedures
Postoperative pain
Time frame: Since the end of the operation to 48 h follow-up.
Postoperative bleeding
Time frame: Since the end of operation to 48 h follow-up
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 15 Jul 2009.
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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 chair
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 Phase 4 study testing Fentanyl Citrate and Butorphanol Tartrate in people with Abortion and Curettage, 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 15 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Intraoperative awareness (time frame: During the whole process of 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 15 Jul 2009.