Cholecystectomy, LaparoscopicPhase 4NCT01523886
The Muscle Relaxation-study
A Phase 4 study testing Rocuronium in people with Cholecystectomy, Laparoscopic, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystectomy, Laparoscopic
- What is being tested?
- Rocuronium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2012to Nov 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years
- Scheduled for elective laparoscopic cholecystectomy
- Can read and understand danish
- Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives
Who cannot join
- Known allergy to medications that are included in the project
- Presence of severe renal disease, neuromuscular disease, reduced liver function
- Nursing or pregnant
- Indication for crash induction
- For fertile women: Missing negative pregnancy-test
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of anesthesia and department of gastro-intestinale diseases, Aleris-Hamlet
Soeborg, 2860
About this study
Official title: Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade
The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.
The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.
Read the detailed description
The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.
- Conditions
- Cholecystectomy, Laparoscopic
- Being tested
- Rocuronium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RocuroniumDrug
Also called Esmeron
Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
RocuroniumDrug
Also called Esmeron
Intravenous use: 0,3 mg/kg followed by NaCl-infusion
| Study group | Role | What they receive |
|---|---|---|
| Deep neuromuscular blockade | Active comparator | Not described Receives: Drug: Rocuronium |
| Moderate neuromuscular blockade | Placebo comparator | Not described Receives: Drug: Rocuronium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less
The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.
Measured: From surgical incision to last suture has been placed, an expected average of 30 minutes
Secondary outcomes (12)
Surgical Space Conditions
The surgical space conditions (VAS 0-100) assessed at the time during surgery, when they were poorest
Measured: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Surgical Space Conditions
The average surgical space conditions (VAS 0-100 and 4-stage scale) during the procedure.
Measured: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Surgical Space Conditions
The surgical space conditions during dissection of the gallbladder (4-stage scale and VAS 0-100).
Measured: During dissection of the gallbladder
Pain
Pain (shoulder, incision, deep abdominal and general) as the area under the curve from preoperatively to 7 days after surgery.
Measured: Preoperatively to 7 days after surgery
Pain
Pain (shoulder, incision, deeop abdominal and general) at arrival to the postanesthesia care department, 2 hours and 1 day after surgery.
Measured: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery
Normal Functional Level
Numer of days before re-establing normal functional level
Measured: from the day of surgery to re-establishing normal functional level - an expected average of 7 days.
Surgical Procedures at Low Pneumoperitoneum
Number of procedures which can be done with pneumoperitoneum 8 mmHg
Measured: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Duration of Surgery
Duration of surgery
Measured: From surgical incision to last suture has been placed.
Duration of Anesthesia
Duration of anesthesia
Measured: From induction of anesthesia to patient ready to leave the operating theatre
Consumption of Analgesics
Consumption of analgesics during the first 24 hours after surgery
Measured: The first 24 hours after surgery
Nausea and Vomiting
The incidence of nausea and vomiting during the first 24 hours after surgery
Measured: The first 24 hours after surgery
Anti-emetics
Use of anti-emetics during the first 24 hours after surgery
Measured: During the first 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 posted1 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystectomy, LaparoscopicStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Kathrine Staehr-Rye, Herlev Hospital
- Investigators
- Anne K Staehr, MD, Principal investigator, Department of anesthesia, Herlev Hospital, DenmarkMona R Gätke, MD, Ph.D, Study chair, Department of anesthesia, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523886
- Sponsor's protocol ID
- 2011-441
- Status last verified
- Mar 2014
- First submitted
- 19 Jan 2012
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.
PubMed 23461992
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Surgical Conditions During Laparoscopic Cholecystectomy With Deep or Moderate Neuromuscular Blockade
- ClinicalTrials.gov ID
- NCT01523886
- Acronym / sponsor ID
- 2011-441
- Conditions
- Cholecystectomy, Laparoscopic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 21 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to compare the surgical conditions during laparoscopic cholecystectomy at a low intra-abdominal pressure with deep or moderate muscle relaxation.
The primary hypothesis is that surgical conditions during laparoscopic cholecystectomy are better with deep muscle relaxation than moderate muscle relaxation.
Detailed description
The purpose of this investigation is to compare the surgical conditions with two degrees of neuromuscular blockade in patients who have laparoscopic cholecystectomy done with pneumoperitoneum 8 mmHg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep neuromuscular blockade | Active comparator | Drug: Rocuronium |
| Moderate neuromuscular blockade | Placebo comparator | Drug: Rocuronium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years
- Scheduled for elective laparoscopic cholecystectomy
- Can read and understand danish
- Women must be post-menopausal, sterilized or use safe contraception in the form of a coil or oral anti-contraceptives
Key exclusion criteria (5 listed)
- Known allergy to medications that are included in the project
- Presence of severe renal disease, neuromuscular disease, reduced liver function
- Nursing or pregnant
- Indication for crash induction
- For fertile women: Missing negative pregnancy-test
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 |
|---|---|---|
| RocuroniumAlso: EsmeronIntravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h | Drug | Deep neuromuscular blockade |
| RocuroniumAlso: EsmeronIntravenous use: 0,3 mg/kg followed by NaCl-infusion | Drug | Moderate neuromuscular blockade |
Primary outcome
The Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes
The surgical space conditions (4-stage scale) assessed at the time during surgery, when view was less. The laparoscopies were performed by experienced surgeons, whom were asked to evaluate surgical space conditions with a 4-point scale : Grade 1 ("optimal") = "optimal" surgical space conditions; Grade 2 (good) = non-optimal conditions, but an intervention was not considered; Grade 3 (acceptable) = an intervention was considered in order to improve surgical space; Grade 4 (poor) = inadequate conditions and an intervention was necessary in order to ensure acceptable surgical space.
12 secondary outcomes
Surgical Space Conditions
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Surgical Space Conditions
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Surgical Space Conditions
Time frame: During dissection of the gallbladder
Pain
Time frame: Preoperatively to 7 days after surgery
Pain
Time frame: At arrival to the postanesthesia care department, 2 hours and 1 day after surgery
Normal Functional Level
Time frame: from the day of surgery to re-establishing normal functional level - an expected average of 7 days.
Surgical Procedures at Low Pneumoperitoneum
Time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes.
Duration of Surgery
Time frame: From surgical incision to last suture has been placed.
Duration of Anesthesia
Time frame: From induction of anesthesia to patient ready to leave the operating theatre
Consumption of Analgesics
Time frame: The first 24 hours after surgery
Nausea and Vomiting
Time frame: The first 24 hours after surgery
Anti-emetics
Time frame: During the first 24 hours after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23461992Staehr-Rye AK, Rasmussen LS, Rosenberg J, Juul P, Gatke MR. Optimized surgical space during low-pressure laparoscopy with deep neuromuscular blockade. Dan Med J. 2013 Feb;60(2):A4579.
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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.
Anne K Staehr, MD principal investigator
Department of anesthesia, Herlev Hospital, Denmark
Mona R Gätke, MD, Ph.D study chair
Department of anesthesia, Herlev Hospital
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 in people with Cholecystectomy, Laparoscopic, 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 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 21 Apr 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?
Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Percentage of Patients With Optimal Surgical Space Conditions ( 1 at a 4-step Scale) Assessed at the Time During Surgery, When View Was Less (time frame: From surgical incision to last suture has been placed, an expected average of 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01523886, which also lists 1 linked publication.
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 21 Apr 2014.