CURES: The Effect of Deep Curarisation and Reversal With Sugammadex on Surgical Conditions and Perioperative Morbidity

Summary

The purpose of this study is to investigate if a deep neuromuscular block with a continuous infusion of rocuronium titrated to a post-tetanic count (PTC) of 1-2 responses combined with reversal of neuromuscular blockade with sugammadex results in improved surgical conditions for the surgeon and/or improved post-operative respiratory function for the patients as compared to a standard technique with an intubation dose of rocuronium and top-ups as needed to maintain a neuromuscular blockade with a train of four (TOF) count of 1-2 and reversal of neuromuscular blockade with neostigmine/glycopyrrolate.

Furthermore, we want to investigate the effect of pneumoperitoneum, and NMB with rocuronium and reversal with sugammadex or neostigmine/glycopyrrolate on cerebral tissue oxygenation.

Conditions

• Obesity
• Laparoscopic Gastric Bypass Surgery
• Surgical Conditions
• Respiratory Function
• Cerebral Tissue Oxygenation

Interventions

DRUG

deep neuromuscular blockade with rocuronium, reversal with sugammadex

after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio \> 0.9.

DRUG

normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine

After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is \> 0.9.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Ziekenhuis Oost-Limburg

  lead OTHER

Principal Investigators

• Pieter De Vooght, M.D. · Ziekenhuis Oost-Limburg

• Jeroen Van Melkebeek, M.D. · Ziekenhuis Oost-Limburg

• Dimitri Dylst, M.D. · Ziekenhuis Oost-Limburg

• Maud Beran, M.D. · Ziekenhuis Oost-Limburg

• Margot Vander Laenen, M.D. · Ziekenhuis Oost-Limburg

• Jan Van Zundert, M.D., PhD. · Ziekenhuis Oost-Limburg

• René Heylen, M.D., PhD. · Ziekenhuis Oost-Limburg

• Hans Verhelst, M.D. · Ziekenhuis Oost-Limburg

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2015-01-31

Completion

2015-01-31

Countries

• Belgium

Study Locations