NCT01152905

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2010

Completed
Last Updated

June 29, 2010

Status Verified

November 1, 2006

Enrollment Period

1.3 years

First QC Date

June 28, 2010

Last Update Submit

June 28, 2010

Conditions

Keywords

Neuromuscular blockadeNeuromuscular blocking agentsAtracuriumNitrous oxide

Study Arms (2)

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 Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • ASA physical status I-III patients

You may not qualify if:

  • Patients with significant renal,
  • Hepatic or cardiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University Hospital

Turku, FI-20520, Finland

Location

Related Publications (1)

  • Illman HL, Antila HM, Olkkola KT. Effect of nitrous oxide on cisatracurium infusion demands: a randomized controlled trial. BMC Anesthesiol. 2010 Aug 18;10:14. doi: 10.1186/1471-2253-10-14.

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

June 28, 2010

First Posted

June 29, 2010

Study Start

April 1, 2007

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

June 29, 2010

Record last verified: 2006-11

Locations