Patients Ongoing Elective Abdominal LaparoscopyPhase 4COELIOCURNCT02816567
Laparoscopic Surgery and Abdominal Compliance
A Phase 4 study testing propofol, NMBA - cisatracurium and sufentanil in people with Patients Ongoing Elective Abdominal Laparoscopy, run by CHU de Reims at 1 site in France.
Trial summary
The objective of the study is to describe factors influencing abdominal compliance during laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance is measured by pressure/volume relationship. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Ongoing Elective Abdominal Laparoscopy
- What is being tested?
- propofol, NMBA - cisatracurium and sufentanil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to Jan 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective abdominal laparoscopy (cholecystectomy, colectomy, gastric bypass, sleeve gastrectomy, hepatic resection, splenectomy, hernial surgery, explorative laparoscopy)
- >18 yo
- patients who accept the protocol and sign it
- patients affiliated at the social security
Who cannot join
- formal indication of NMBA use (predictive difficult tracheal intubation, predictive difficult facial ventilation)
- patients who needs a crush induction
- NMBA allergia
- patients who present a contraindication to the propofol or sufentanil
- pregnancy
- breastfeeding womens
- patients protected by the law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Reims
France, Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
Official title: Laparoscopic Surgery and Abdominal Compliance Factors Including Neuromuscular Blocking Agents
The objective of the study is to describe factors influencing abdominal compliance during laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance is measured by pressure/volume relationship.
Read the detailed description
Background and rationale. Abdominal laparoscopic surgery is widely used. The meet good conditions, the surgeons need a large enough workspace. Carbonic gaz is insufflated in the intraperitoneal space but limited by the induced pressure which usually must not be above 15mm mercury (Hg) because of subsequent organ failures. The relationship between pressure and gaz volume insufflated defines the abdominal compliance (ΔV/ΔP).
The use of neuromuscular blocking agents (NMBA) is often used during abdominal laparoscopic surgery in order to reduce abdominal tonus, create a sufficient laparoscopic workspace hence improving abdominal compliance. However, considering good working conditions could be achieved by the use of NMBA, other factors could be considered like body weight, length, BMI, surgical abdominal history, parity.
Main objective : To compare the working surgical conditions and the pneumoperitoinea volume obtained during abdominal laparoscopic surgery with and without initial NMBA use.
Hypothesis: The use of NMBA improve the incidence of good surgical working conditions.
Study Design : Randomized blinded clinical trial. Two patients groups are compared, one receiving NMBA and one receiving a placebo. Randomisation will be realised by 1/1 ratio in blocks of 4.
The primary outcome is a composite criteria : the obtention of laparoscopic workspace greater than 3 liters associated with an abdominal pressure lesser than 15mmHg and a good surgical rating scale.
A statistical analysis reveal that 90 patients in each group need to be included from estimated 90% satisfying surgical conditions in NMBA group and 70% in placebo group.
In the placebo group, when surgical conditions are not correct (insufflated volume lesser than 3 liters or surgeon dissatisfaction), NMBA are used. This define the secondary use of NMBA.
Methods :
Anesthesia will be induced in all patients by target controlled infusions of propofol and sufentanil respectively with initial targets of 6 microgram/ml and 0,4 ng/ml.
The initial NMBA bolus in the NMBA group is 0,15 mg/kg of cisatracurium. A similar volume of isotonic saline serum is used in the placebo group.
The abdomen is inflated to 5, 10 and 15 mmHg and volumes at each pressure level are measured in order to evaluate the abdominal compliance.
After those measures, the anesthesiologist is unblinded of NMBA use. If the workspace volume is lesser than 3 liters, or, in case of surgeon dissatisfaction (using the surgical rating scale), NMBA can be used, defining secondary NMBA used.
Anesthesia is maintained by continous infusions of propofol and sufentanil aiming BIS target of 40 to 60.
When used, curarisation is maintained by a continuous infusion of cisatracurium (0,06 to 0,12 mg/kg/h) targetting 0 or 1 TOF response.
Safety issues : During anesthesia induction, if ventilation or tracheal intubation difficulties were to happen, the anesthesiologist is unblinded and any anesthesia protocol can be used.
- Being tested
- propofol, NMBA - cisatracurium, placebo - isotonic saline serum, sufentanil, laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
NMBA - cisatracuriumDrug
placebo - isotonic saline serumDrug
sufentanilDrug
laparoscopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| NMBA group | Experimental | Not described Receives: Drug: propofol; Drug: NMBA - cisatracurium; Drug: sufentanil; Procedure: laparoscopic surgery |
| placebo group | Placebo comparator | Not described Receives: Drug: propofol; Drug: placebo - isotonic saline serum; Drug: sufentanil; Procedure: laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of pneumoperiteum laparoscopic workspace
laparoscopic workspace assessed by volume of pneumoperiteum > 3 Liters
Measured: Day 0 (after anesthesia induction)
score SRS (Surgical Rating Scale)
Measured: Day 0 (after anesthesia induction)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Ongoing Elective Abdominal LaparoscopyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816567
- Sponsor's protocol ID
- PA16045
- Acronym
- COELIOCUR
- Status last verified
- Jul 2016
- First submitted
- 20 Jun 2016
- Last updated
- 18 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Surgery and Abdominal Compliance Factors Including Neuromuscular Blocking Agents
- ClinicalTrials.gov ID
- NCT02816567
- Acronym / sponsor ID
- COELIOCUR / PA16045
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- First posted
- 28 Jun 2016 (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 objective of the study is to describe factors influencing abdominal compliance during laparoscopic surgery, including neuromuscular blocking agents (NMBA). The use of NMBA is randomized and blinded from the surgeons and the anesthesiologist. The abdominal compliance is measured by pressure/volume relationship.
Detailed description
Background and rationale. Abdominal laparoscopic surgery is widely used. The meet good conditions, the surgeons need a large enough workspace. Carbonic gaz is insufflated in the intraperitoneal space but limited by the induced pressure which usually must not be above 15mm mercury (Hg) because of subsequent organ failures. The relationship between pressure and gaz volume insufflated defines the abdominal compliance (ΔV/ΔP).
The use of neuromuscular blocking agents (NMBA) is often used during abdominal laparoscopic surgery in order to reduce abdominal tonus, create a sufficient laparoscopic workspace hence improving abdominal compliance. However, considering good working conditions could be achieved by the use of NMBA, other factors could be considered like body weight, length, BMI, surgical abdominal history, parity.
Main objective : To compare the working surgical conditions and the pneumoperitoinea volume obtained during abdominal laparoscopic surgery with and without initial NMBA use.
Hypothesis: The use of NMBA improve the incidence of good surgical working conditions.
Study Design : Randomized blinded clinical trial. Two patients groups are compared, one receiving NMBA and one receiving a placebo. Randomisation will be realised by 1/1 ratio in blocks of 4.
The primary outcome is a composite criteria : the obtention of laparoscopic workspace greater than 3 liters associated with an abdominal pressure lesser than 15mmHg and a good surgical rating scale.
A statistical analysis reveal that 90 patients in each group need to be included from estimated 90% satisfying surgical conditions in NMBA group and 70% in placebo group.
In the placebo group, when surgical conditions are not correct (insufflated volume lesser than 3 liters or surgeon dissatisfaction), NMBA are used. This define the secondary use of NMBA.
Methods :
Anesthesia will be induced in all patients by target controlled infusions of propofol and sufentanil respectively with initial targets of 6 microgram/ml and 0,4 ng/ml.
The initial NMBA bolus in the NMBA group is 0,15 mg/kg of cisatracurium. A similar volume of isotonic saline serum is used in the placebo group.
The abdomen is inflated to 5, 10 and 15 mmHg and volumes at each pressure level are measured in order to evaluate the abdominal compliance.
After those measures, the anesthesiologist is unblinded of NMBA use. If the workspace volume is lesser than 3 liters, or, in case of surgeon dissatisfaction (using the surgical rating scale), NMBA can be used, defining secondary NMBA used.
Anesthesia is maintained by continous infusions of propofol and sufentanil aiming BIS target of 40 to 60.
When used, curarisation is maintained by a continuous infusion of cisatracurium (0,06 to 0,12 mg/kg/h) targetting 0 or 1 TOF response.
Safety issues : During anesthesia induction, if ventilation or tracheal intubation difficulties were to happen, the anesthesiologist is unblinded and any anesthesia protocol can be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMBA group | Experimental | Drug: propofol, Drug: NMBA - cisatracurium, Drug: sufentanil, Procedure: laparoscopic surgery |
| placebo group | Placebo comparator | Drug: propofol, Drug: placebo - isotonic saline serum, Drug: sufentanil, Procedure: laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- elective abdominal laparoscopy (cholecystectomy, colectomy, gastric bypass, sleeve gastrectomy, hepatic resection, splenectomy, hernial surgery, explorative laparoscopy)
- >18 yo
- patients who accept the protocol and sign it
- patients affiliated at the social security
Key exclusion criteria (7 listed)
- formal indication of NMBA use (predictive difficult tracheal intubation, predictive difficult facial ventilation)
- patients who needs a crush induction
- NMBA allergia
- patients who present a contraindication to the propofol or sufentanil
- pregnancy
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 |
|---|---|---|
| propofol | Drug | NMBA group, placebo group |
| NMBA - cisatracurium | Drug | NMBA group |
| placebo - isotonic saline serum | Drug | placebo group |
| sufentanil | Drug | NMBA group, placebo group |
| laparoscopic surgery | Procedure or surgery | NMBA group, placebo group |
Primary outcome
Volume of pneumoperiteum laparoscopic workspace
Time frame: Day 0 (after anesthesia induction)
laparoscopic workspace assessed by volume of pneumoperiteum > 3 Liters
score SRS (Surgical Rating Scale)
Time frame: Day 0 (after anesthesia induction)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2016.
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.
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 propofol, NMBA - cisatracurium and sufentanil in people with Patients Ongoing Elective Abdominal Laparoscopy, run by CHU de Reims at 1 site in France.
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 7 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: status not confirmed, as of the sponsor's last update on 18 Jul 2016. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beny Charbit (326787029 ext. 33, bcharbit@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of pneumoperiteum laparoscopic workspace (time frame: Day 0 (after anesthesia induction)). The study lists 2 primary outcomes in all. 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 18 Jul 2016.