Surgical ConditionsPhase 4NCT02079337
Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery
A Phase 4 study testing Rocuronium and sugammadex in people with Surgical Conditions and Rating Scales, run by Herlev Hospital at 1 site in Denmark.
Trial summary
Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgical Conditions, Rating Scales, Laparoscopy
- What is being tested?
- Rocuronium and sugammadex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Apr 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients > 18 years old
- elective gynecologic laparoscopic operation
- can read and understand Danish
- informed consent
Who cannot join
- BMI > 30 kg/cm2
- known allergy to medications that are included in the project
- severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis)
- neuromuscular disease that may interfere with neuromuscular data
- lactating or pregnant
- impaired liver function
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- converting to laparotomy
- perioperative use of neuromuscular blocking agents before randomization
- pneumoperitoneum set to >12 mmHg on the insufflator
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of minimal invasive gynecology Aleris-Hamlet Private Hospital
Søborg, 2860
About this study
Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical studies investigating this question often use a numerical or verbal rating scale for subjective evaluation of the surgical workspace. However, no good subjective rating scale have been developed or validated. Neither have possible inter-individual differences in use of such subjective scales been described.
Purpose:
The aim of this study is to validate different subjective rating scales to determine which scale is most useful among surgeons.
- Being tested
- Rocuronium, sugammadex, placebo
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
sugammadexDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Deep NMB | Active comparator | Videorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade Receives: Drug: Rocuronium; Drug: sugammadex; Drug: placebo |
| No NMB | Placebo comparator | Videorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade. Receives: Drug: Rocuronium; Drug: sugammadex; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective rating scale
The subjective rating scale with best possible interobserver agreement described by kappa statistics
Measured: Evaluation of video images within a time frame of in average 5 months after surgery
Secondary outcomes (2)
Number of correct estimates of level of NMB
Measured: Evaluation of video images within a time frame of in average 5 months after surgery
Number of correct estimates of level of NMB according to grade of surgical experience
Measured: Evaluation of video images within a time frame of in average 5 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical ConditionsStudies 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 4
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matias Vested Madsen, Herlev Hospital
- Investigators
- Matias V Madsen, MD, Principal investigator, Herlev Hospital Department of Anethesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079337
- Sponsor's protocol ID
- NMBVAL2013
- Status last verified
- Jul 2014
- First submitted
- 26 Feb 2014
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Subjective Rating Scales Used to Assess Surgical Conditions in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02079337
- Acronym / sponsor ID
- NMBVAL2013
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Mar 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.
Use of neuromuscular blockade (NMB) may improve the surgical work space in patients scheduled for laparoscopic surgical cases (e.g. hysterectomy, ovarian cystectomy, myomectomy). Clinical studies investigating this question often use a numerical or verbal rating scale for subjective evaluation of the surgical workspace. However, no good subjective rating scale have been developed or validated. Neither have possible inter-individual differences in use of such subjective scales been described.
Purpose:
The aim of this study is to validate different subjective rating scales to determine which scale is most useful among surgeons.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep NMB | Active comparator | Drug: Rocuronium, Drug: sugammadex, Drug: placeboVideorecordings and subjective ratings of intraabdominal surgical conditions during deep neuromuscular blockade and without neuromuscular blockade |
| No NMB | Placebo comparator | Drug: Rocuronium, Drug: sugammadex, Drug: placeboVideorecordings and subjective ratings of intraabdominal surgical conditions during no neuromuscular blockade and during deep neuromuscular blockade. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients > 18 years old
- elective gynecologic laparoscopic operation
- can read and understand Danish
- informed consent
Key exclusion criteria (9 listed)
- BMI > 30 kg/cm2
- known allergy to medications that are included in the project
- severe renal disease, defined by S-creatinine> 0,200 mmol/L, GFR < 30ml/min or hemodialysis)
- neuromuscular disease that may interfere with neuromuscular data
- lactating or pregnant
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 |
|---|---|---|
| Rocuronium | Drug | Deep NMB, No NMB |
| sugammadex | Drug | Deep NMB, No NMB |
| placebo | Drug | Deep NMB, No NMB |
Primary outcome
Subjective rating scale
Time frame: Evaluation of video images within a time frame of in average 5 months after surgery
The subjective rating scale with best possible interobserver agreement described by kappa statistics
2 secondary outcomes
Number of correct estimates of level of NMB
Time frame: Evaluation of video images within a time frame of in average 5 months after surgery
Number of correct estimates of level of NMB according to grade of surgical experience
Time frame: Evaluation of video images within a time frame of in average 5 months 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 9 Jul 2014.
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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.
Matias V Madsen, MD principal investigator
Herlev Hospital Department of Anethesiology
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 Rocuronium and sugammadex in people with Surgical Conditions and Rating Scales, run by Herlev Hospital at 1 site in Denmark.
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 4 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 9 Jul 2014. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Subjective rating scale (time frame: Evaluation of video images within a time frame of in average 5 months after 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 9 Jul 2014.