Dose Finding Study for Effective Reversal of a Deep Rocuronium-induced Neuromuscular Block With Sugammadex in Morbidly Obese Patients

Phase 2

Completed

• Conditions: Morbidly Obese Patients
• Interventions: Drug: Sugammadex 2 mg/kg; Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

• Registration Number: NCT01911520
• Lead Sponsor: University Hospital, Ghent

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

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-26
• Study First Posted: 2013-07-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMI >50, IBW, 2 mg/kg	Sugammadex 2 mg/kg	Patients with a BMI \> 50, who will be dosed according to ideal body weight.
BMI < 50, Ideal Body Weight (IBW), 2 mg/kg	Sugammadex 2 mg/kg	Patients with a BMI \< 50, who will be dosed according to ideal body weight.
BMI < 50, IBW, 4 mg/kg	Sugammadex. 4 mg/kg	Patients with a BMI \< 50, who will be dosed according to ideal body weight.
BMI < 50, Ideal Body Weight (IBW), 2 mg/kg	Neuromuscular monitoring.	Patients with a BMI \< 50, who will be dosed according to ideal body weight.
BMI < 50, Total Body Weight (TBW), 2mg/kg	Sugammadex 2 mg/kg	Patients with a BMI \< 50, who will be dosed according to total body weight.
BMI < 50, Total Body Weight (TBW), 2mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \< 50, who will be dosed according to total body weight.
BMI < 50, TBW, 4 mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \< 50, who will be dosed according to total body weight.
BMI > 50, TBW, 4mg/kg	Sugammadex. 4 mg/kg	Patients with a BMI \> 50, who will be dosed according to total body weight.
BMI >50, IBW, 2 mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \> 50, who will be dosed according to ideal body weight.
BMI < 50, Ideal Body Weight (IBW), 2 mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \< 50, who will be dosed according to ideal body weight.
BMI < 50, TBW, 4 mg/kg	Neuromuscular monitoring.	Patients with a BMI \< 50, who will be dosed according to total body weight.
BMI < 50, IBW, 4 mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \< 50, who will be dosed according to ideal body weight.
BMI >50, IBW, 4 mg/kg	Sugammadex. 4 mg/kg	Patients with a BMI \> 50, who will be dosed according to ideal body weight.
BMI >50, IBW, 4 mg/kg	Neuromuscular monitoring.	Patients with a BMI \> 50, who will be dosed according to ideal body weight.
BMI < 50, Total Body Weight (TBW), 2mg/kg	Neuromuscular monitoring.	Patients with a BMI \< 50, who will be dosed according to total body weight.
BMI < 50, TBW, 4 mg/kg	Sugammadex. 4 mg/kg	Patients with a BMI \< 50, who will be dosed according to total body weight.
BMI > 50, TBW, 4mg/kg	Neuromuscular monitoring.	Patients with a BMI \> 50, who will be dosed according to total body weight.
BMI > 50, TBW, 4mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \> 50, who will be dosed according to total body weight.
BMI < 50, IBW, 4 mg/kg	Neuromuscular monitoring.	Patients with a BMI \< 50, who will be dosed according to ideal body weight.
BMI > 50, TBW, 2mg/kg	Sugammadex 2 mg/kg	Patients with a BMI \> 50, who will be dosed according to total body weight.
BMI > 50, TBW, 2mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \> 50, who will be dosed according to total body weight.
BMI >50, IBW, 2 mg/kg	Neuromuscular monitoring.	Patients with a BMI \> 50, who will be dosed according to ideal body weight.
BMI > 50, TBW, 2mg/kg	Neuromuscular monitoring.	Patients with a BMI \> 50, who will be dosed according to total body weight.
BMI >50, IBW, 4 mg/kg	Clinical evaluation of residual curarization .	Patients with a BMI \> 50, who will be dosed according to ideal body weight.

Primary Outcome Measures

Name	Time	Method
Time to complete recovery of muscle relaxation, 30 minutes after end of surgery.	30 minutes after end of surgery.	Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 1 hour after the end of surgery.	1hour after end of surgery.	Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the end of surgery.	1hour 30 minutes after end of surgery.	Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.
Time to complete recovery of muscle relaxation, 2 hours after the end of surgery.	2 hours after end of surgery.	Measured with TOF Watch SX (TOF ratio \> 0.9); clinical evaluation (eg head lift) of residual curarization in the Post Anesthetic Care.

Secondary Outcome Measures

Name	Time	Method
Need/use of rescue medication at the end of surgery	The hours following the end of surgery.	Additional administration of sugammadex 2 mg/kg Total Body Weight) at the end of surgery.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium