Clinical trial NCT01911520: Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients
Official title: Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Morbidly Obese Patients
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During laparoscopic bariatric surgery, adequate muscle relaxation is important to maintain good surgical conditions. To achieve this muscle relaxation, neuromuscular transmission blocking agents, such as rocuronium (Esmeron®) are used. It sometimes happens that there is still some neuromuscular blocking activity left in the patient on awakening from anesthesia. This is called residual curarization and is known to cause postoperative complications such as impairment of respiratory function.

Sugammadex (Bridion®) is a novel drug which selectively binds rocuronium (Esmeron®). It allows for reversing of neuromuscular transmission blocking activity. Until now, all studies with sugammadex were performed in non-obese patients.

Obese patient have a high risk to suffer from post-operative respiratory failure. Therefore it is vital to avoid residual curarization. Sugammadex might be an important factor.

Obese patients have a large total body weight different from ideal body weight. Recent research demonstrated that the dose for the neuromuscular blocking agent rocuronium (Esmeron®) needs to be calculated on the patients' Ideal Body Weight rather than on Total Body Weight.

At this moment no data is available on the dose-response relationship of sugammadex in morbidly obese patients.

We hypothesize that in morbidly obese patients sugammadex should be dosed on ideal bodyweight, instead of total bodyweight.

Detailed description: Flowchart :

72 participants

Stratification

BMI\<50 BMI \>50

Randomization Randomization

TBW IBW TBW IBW

2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 2mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9 4mg/kg n=9

TBW : Total Body Weight IBW : Ideal Body Weight

Eligibility criteria: Inclusion criteria :

* ASA I-II-III
* Age 18 - 65 year
* Male or female
* BMI \> 30

Exclusion criteria :

* Renal failure
* Liver dysfunction
* Breastfeeding female patients, or female patients without reliable contraception
* Neuromuscular disease
* Malignant hyperthermia or a family history of malignant hyperthermia
* Allergy for neuromuscular blocking agents or other medications used during general anesthesia
* Infectious disease or patients with fever
* Patients who already received rocuronium or sugammadex on the day of the study

Primary outcomes:
measure: Time to complete recovery of muscle relaxation, 30 minutes after end of surgery.
timeFrame: 30 minutes after end of surgery.
measure: Time to complete recovery of muscle relaxation, 1 hour after the end of surgery.
timeFrame: 1hour after end of surgery.
measure: Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery.
timeFrame: 1hour 30 minutes after end of surgery.
measure: Time to complete recovery of muscle relaxation, 2 hours after the end of surgery.
timeFrame: 2 hours after end of surgery.
Secondary outcomes:
measure: Need/use of rescue medication at the end of surgery
timeFrame: The hours following the end of surgery.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
Study officials:
affiliation: University Hospital, Ghent
name: Jurgen Van Limmen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Luc De Baerdemaeker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Ghent
name: Koen Reyntjens, MD
role: PRINCIPAL_INVESTIGATOR
References: