C.Delivery; Surgery (Previous), GynecologicalPhase 4NCT02194855
Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis
A Phase 4 study testing rocuronium and cisatracurium in people with C.Delivery; Surgery (Previous), Gynecological, run by Fudan University.
Trial summary
The investigators investigated whether laparoscopic versus open surgical approaches affected the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or cisatracurium. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- C.Delivery; Surgery (Previous), Gynecological
- What is being tested?
- rocuronium and cisatracurium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2016
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiology 1-2
- BMI 18-30 kg.m-2
- elective gynaecological operations under general anaesthesia
Who cannot join
- cirrhosis
- hepatitis
- hepatoma
- heart failure
- arrhythmia
- renal dysfunction
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- electrolyte disturbances
- acid-base imbalances
- neuromuscular disorders
About this study
Official title: Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis.
The investigators investigated whether laparoscopic versus open surgical approaches affected the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or cisatracurium.
- Being tested
- rocuronium, cisatracurium
- Keywords
- rocuronium, cisatracurium, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rocuroniumDrug
Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus
cisatracuriumDrug
cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic operation on rocuronium | Experimental | according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. Receives: Drug: rocuronium |
| laparoscopic operation on cisatracurium | Experimental | according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. Receives: Drug: cisatracurium |
| conventional open surgery on rocuronium | Experimental | according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. Receives: Drug: rocuronium |
| conventional open surgery on cisatracurium | Experimental | according different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. Receives: Drug: cisatracurium |
What is being measured
The primary outcome is the main question the study is designed to answer.
the blood flow in the right and middle hepatic veins
Measurements of the blood flow in the right and middle hepatic veins were performed at baseline and 1,5, 10, 20, 30min after insufflation of carbon dioxide or incise the skin as well as 1 and 5 min after deflation or close the wound.
Measured: up to 9 months
Secondary outcomes (1)
the plasma Concentration of rocuronium and cisatracurium
Venous blood samples (3 ml) were taken 2 min prior to and at 5,30, 60 min following administration of rocuronium/cisatracurium.The aim of the present was to study the blood concentration of rocuronium/cisatracurium in laparoscopic surgery compared with conventional open gynaecological surgery
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study start1 Jan 2015
- Primary completion1 Jan 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Delivery; Surgery (Previous), GynecologicalStudies of the same condition, open and under way.
- More trials run by Fudan 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tingting Wang, Fudan University
- Investigators
- Shaoqiang Huang, doctor, Principal investigator, Obstetrics and Gynecology,Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194855
- Sponsor's protocol ID
- TingtingWang
- Status last verified
- Aug 2020
- First submitted
- 11 Jul 2014
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Operation on Rocuronium and Cisatracurium: Pharmacokinetic and Pharmacodynamic Analysis.
- ClinicalTrials.gov ID
- NCT02194855
- Acronym / sponsor ID
- TingtingWang
- Keywords
- rocuronium, cisatracurium, pharmacokinetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 18 Jul 2014 (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.
The investigators investigated whether laparoscopic versus open surgical approaches affected the pharmacokinetic and pharmacodynamic of a single bolus dose of rocuronium or cisatracurium.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| laparoscopic operation on rocuronium | Experimental | Drug: rocuroniumaccording different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. |
| laparoscopic operation on cisatracurium | Experimental | Drug: cisatracuriumaccording different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. |
| conventional open surgery on rocuronium | Experimental | Drug: rocuroniumaccording different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. |
| conventional open surgery on cisatracurium | Experimental | Drug: cisatracuriumaccording different surgical type, all patients were divided into 2 groups: the laparoscopic surgery group and open surgery group.Each group were randomly assigned to the rocuronium group and cisatracurium group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiology 1-2
- BMI 18-30 kg.m-2
- elective gynaecological operations under general anaesthesia
Key exclusion criteria (9 listed)
- cirrhosis
- hepatitis
- hepatoma
- heart failure
- arrhythmia
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 |
|---|---|---|
| rocuroniumRocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus | Drug | conventional open surgery on rocuronium, laparoscopic operation on rocuronium |
| cisatracuriumcisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus | Drug | conventional open surgery on cisatracurium, laparoscopic operation on cisatracurium |
Primary outcome
the blood flow in the right and middle hepatic veins
Time frame: up to 9 months
Measurements of the blood flow in the right and middle hepatic veins were performed at baseline and 1,5, 10, 20, 30min after insufflation of carbon dioxide or incise the skin as well as 1 and 5 min after deflation or close the wound.
1 secondary outcome
the plasma Concentration of rocuronium and cisatracurium
Time frame: up to 9 months
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 12 Aug 2020.
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.
Shaoqiang Huang, doctor principal investigator
Obstetrics and Gynecology,Fudan University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rocuronium and cisatracurium in people with C.Delivery; Surgery (Previous), Gynecological, run by Fudan University.
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 9 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 12 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
the blood flow in the right and middle hepatic veins (time frame: up to 9 months). 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 12 Aug 2020.