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

NCT01911520 | Completed Phase 2

• 2 other identifiers: 2010/2072009-016857-16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbidly Obese Patients

Outcome Measures

Primary Outcomes (4)

• Time to complete recovery of muscle relaxation, 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.

  30 minutes after end of surgery.

• Time to complete recovery of muscle relaxation, 1 hour after the 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.

  1hour after end of surgery.

• Time to complete recovery of muscle relaxation, 1 hour 30 minutes after the 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.

  1hour 30 minutes after end of surgery.

• Time to complete recovery of muscle relaxation, 2 hours after the 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.

  2 hours after end of surgery.

Secondary Outcomes (1)

• Need/use of rescue medication at the end of surgery

  The hours following the end of surgery.

Study Arms (8)

BMI < 50, Total Body Weight (TBW), 2mg/kg

EXPERIMENTAL

Patients with a BMI \< 50, who will be dosed according to total body weight.

Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

BMI < 50, TBW, 4 mg/kg

EXPERIMENTAL

Patients with a BMI \< 50, who will be dosed according to total body weight.

Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

BMI < 50, Ideal Body Weight (IBW), 2 mg/kg

EXPERIMENTAL

Patients with a BMI \< 50, who will be dosed according to ideal body weight.

Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

BMI < 50, IBW, 4 mg/kg

EXPERIMENTAL

Patients with a BMI \< 50, who will be dosed according to ideal body weight.

Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

BMI > 50, TBW, 2mg/kg

EXPERIMENTAL

Patients with a BMI \> 50, who will be dosed according to total body weight.

Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

BMI > 50, TBW, 4mg/kg

EXPERIMENTAL

Patients with a BMI \> 50, who will be dosed according to total body weight.

Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

BMI >50, IBW, 2 mg/kg

EXPERIMENTAL

Patients with a BMI \> 50, who will be dosed according to ideal body weight.

Drug: Sugammadex 2 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

BMI >50, IBW, 4 mg/kg

EXPERIMENTAL

Patients with a BMI \> 50, who will be dosed according to ideal body weight.

Drug: Sugammadex. 4 mg/kg; Procedure: Neuromuscular monitoring.; Procedure: Clinical evaluation of residual curarization .

Interventions

Sugammadex 2 mg/kg DRUG

Patients receive 2 mg/kg Sugammadex.

BMI < 50, Ideal Body Weight (IBW), 2 mg/kg; BMI < 50, Total Body Weight (TBW), 2mg/kg; BMI > 50, TBW, 2mg/kg; BMI >50, IBW, 2 mg/kg

Sugammadex. 4 mg/kg DRUG

Patients receive 4 mg/kg Sugammadex.

BMI < 50, IBW, 4 mg/kg; BMI < 50, TBW, 4 mg/kg; BMI > 50, TBW, 4mg/kg; BMI >50, IBW, 4 mg/kg

Neuromuscular monitoring. PROCEDURE

Neuromuscular monitoring using a TOF watch SX (Organon).

BMI < 50, IBW, 4 mg/kg; BMI < 50, Ideal Body Weight (IBW), 2 mg/kg; BMI < 50, TBW, 4 mg/kg; BMI < 50, Total Body Weight (TBW), 2mg/kg; BMI > 50, TBW, 2mg/kg; BMI > 50, TBW, 4mg/kg; BMI >50, IBW, 2 mg/kg; BMI >50, IBW, 4 mg/kg

Clinical evaluation of residual curarization . PROCEDURE

Every 30 min, during the first 2 hours after the end of the surgery.

BMI < 50, IBW, 4 mg/kg; BMI < 50, Ideal Body Weight (IBW), 2 mg/kg; BMI < 50, TBW, 4 mg/kg; BMI < 50, Total Body Weight (TBW), 2mg/kg; BMI > 50, TBW, 2mg/kg; BMI > 50, TBW, 4mg/kg; BMI >50, IBW, 2 mg/kg; BMI >50, IBW, 4 mg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead

Study Sites (1)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Related Links

• Related Info

MeSH Terms

Interventions

Sugammadex

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Study Officials

• Jurgen Van Limmen, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Luc De Baerdemaeker, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

• Koen Reyntjens, MD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 30, 2013
• Study Start: January 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

BE (1)