Laparoscopic Surgery and Abdominal Compliance (COELIOCUR)

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ClinicalTrials.gov Identifier: NCT02816567

Recruitment Status : Unknown

Verified July 2016 by CHU de Reims.
Recruitment status was: Recruiting

First Posted : June 28, 2016

Last Update Posted : July 18, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

CHU de Reims

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Patients Ongoing Elective Abdominal Laparoscopy	Drug: propofol Drug: NMBA - cisatracurium Drug: placebo - isotonic saline serum Drug: sufentanil Procedure: laparoscopic surgery	Phase 4

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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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	180 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
Primary Purpose:	Treatment
Official Title:	Laparoscopic Surgery and Abdominal Compliance Factors Including Neuromuscular Blocking Agents
Study Start Date :	January 2016
Estimated Primary Completion Date :	January 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: NMBA group	Drug: propofol Drug: NMBA - cisatracurium Drug: sufentanil Procedure: laparoscopic surgery
Placebo Comparator: placebo group	Drug: propofol Drug: placebo - isotonic saline serum Drug: sufentanil Procedure: laparoscopic surgery

Outcome Measures

Primary Outcome Measures :

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) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816567

Contacts

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Contact: Beny Charbit	326787029 ext 33	bcharbit@chu-reims.fr

Locations

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France
Chu Reims	Recruiting
France, Reims, France, 51092
Contact: Damien JOLLY 326788472 ext 33 djolly@chu-reims.fr

Sponsors and Collaborators

CHU de Reims

More Information

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Responsible Party:	CHU de Reims
ClinicalTrials.gov Identifier:	NCT02816567
Other Study ID Numbers:	PA16045
First Posted:	June 28, 2016 Key Record Dates
Last Update Posted:	July 18, 2016
Last Verified:	July 2016

Additional relevant MeSH terms:

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Sufentanil Propofol Cisatracurium Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics	Analgesics, Opioid Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Adjuvants, Anesthesia Neuromuscular Blocking Agents Neuromuscular Agents

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