Effect of Nitrous Oxide on Cisatracurium Infusion Demands

This study has been completed.
Sponsor:
Information provided by:
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01152905
First received: June 28, 2010
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

Background: Recent studies have questioned our previous understanding on the effect of nitrous oxide on muscle relaxants, since nitrous oxide has been shown to potentiate the action of bolus doses of mivacurium, rocuronium and vecuronium. This study was aimed to investigate the possible effect of nitrous oxide on the infusion requirements of cisatracurium.

Methods: 70 ASA physical status I-III patients aged 18-75 years were enrolled in this randomized trial. The patients were undergoing elective surgery requiring general anesthesia with a duration of at least 90 minutes. Patients were randomized to receive propofol and remifentanil by target controlled infusion in combination with either a mixture of oxygen and nitrous oxide (Nitrous oxide/TIVA group) or oxygen in air (Air/TIVA group). A 0.1 mg/kg initial bolus of cisatracurium was administered before tracheal intubation, followed by a closed-loop computer controlled infusion of cisatracurium to produce and maintain a 90% neuromuscular block. Cumulative dose requirements of cisatracurium during the 90-min study period after bolus administration were measured and the asymptotic steady state rate of infusion to produce a constant 90% block was determined by applying nonlinear curve fitting to the data on the cumulative dose requirement during the study period.

Results: Controller performance, i.e. the ability of the controller to maintain neuromuscular block constant at the setpoint and patient characteristics were similar in both groups. The administration of nitrous oxide did not affect cisatracurium infusion requirements. The mean steady-state rates of infusion were 0.072 +/- 0.018 and 0.066 +/- 0.017 mg * kg-1 * h-1 in Air/TIVA and Nitrous oxide/TIVA groups, respectively.

Conclusions: Nitrous oxide does not affect the infusion requirements of cisatracurium.


Condition
Neuromuscular Blocking Agents

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effect of Nitrous Oxide on Cisatracurium Infusion Demands. A Randomized Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Enrollment: 70
Study Start Date: April 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Air/TIVA group
The patients received during the anesthesia a mixture of air with 30% oxygen All patients received total intravenous anesthesia (TIVA) using target controlled infusion of propofol and remifentanil.
Nitrous oxide/TIVA group
The patients received nitrous oxide with 30% oxygen.All patients received total intravenous anesthesia (TIVA) using target controlled infusion of propofol and remifentanil.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients undergoing elective surgery requiring general anesthesia with a duration of at least 90 minutes.

Criteria

Inclusion Criteria:

  • ASA physical status I-III patients

Exclusion Criteria:

  • Patients with significant renal,
  • Hepatic or cardiac disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01152905

Locations
Finland
Department of Anesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University Hospital
Turku, Finland, FI-20520
Sponsors and Collaborators
Turku University Hospital
  More Information

No publications provided

Responsible Party: Hanna Illman/Consultant Anesthesiologist, Dept. of Anaesthesiology, Intensive Care, Emergency Care and Pain Medicine
ClinicalTrials.gov Identifier: NCT01152905     History of Changes
Other Study ID Numbers: 225/2006
Study First Received: June 28, 2010
Last Updated: June 28, 2010
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
Neuromuscular blockade
Neuromuscular blocking agents
Atracurium
Nitrous oxide

Additional relevant MeSH terms:
Neuromuscular Blocking Agents
Cisatracurium
Nitrous Oxide
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on August 21, 2014