Neuromuscular Blocking AgentsNCT01152905
Effect of Nitrous Oxide on Cisatracurium Infusion Demands
An observational study of Neuromuscular Blocking Agents, run by Turku University Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuromuscular Blocking Agents
- Type of treatment
- Injection or infusion
- How many people
- 70 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2007to Jul 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing elective surgery requiring general anesthesia with a duration of at least 90 minutes.
Who may be able to join
- ASA physical status I-III patients
Who cannot join
- Patients with significant renal,
- Hepatic or cardiac disease
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Anesthesiology, Intensive Care, Emergency Care and Pain Medicine, Turku University Hospital
Turku, FI-20520
About this study
Official title: Effect of Nitrous Oxide on Cisatracurium Infusion Demands. A Randomized Controlled Trial.
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.
Read more
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.
- Conditions
- Neuromuscular Blocking Agents
- Keywords
- Neuromuscular blockade, Neuromuscular blocking agents, Atracurium, Nitrous oxide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2010 (estimated)
- Study startApr 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular Blocking AgentsStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01152905
- Sponsor's protocol ID
- 225/2006
- Status last verified
- Nov 2006
- First submitted
- 28 Jun 2010
- Last updated
- 29 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20718983
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nitrous Oxide on Cisatracurium Infusion Demands. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT01152905
- Acronym / sponsor ID
- 225/2006
- Conditions
- Neuromuscular Blocking Agents
- Keywords
- Neuromuscular blockade, Neuromuscular blocking agents, Atracurium, Nitrous oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- Apr 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 29 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing elective surgery requiring general anesthesia with a duration of at least 90 minutes.
Key inclusion criteria (1 listed)
- ASA physical status I-III patients
Key exclusion criteria (2 listed)
- Patients with significant renal,
- Hepatic or cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2010.
- Derived from this study: PubMed 20718983Illman 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.
Related trials for Neuromuscular Blocking Agents
Not yet recruitingPhase 4
Effect of Neuromuscular Blocking Agent Use on Video Laryngeal Mask Airway Insertion
Airway Management, Supraglottic Airway Device Insertion
Recruiting
TwichView-guided Atricurium Dose Adjustment Trial
ARDS, TTM
Not yet recruitingPhase 4
Fentanyl and Rocuronium for Tracheal Intubation in Newborns
Infant, Premature, Intubation, Intratracheal
RecruitingObservational study
Median Nerve Electromyography to Monitor Intraoperative Neuromuscular Function
Nerve Conduction Study, Elective Surgery
Recruiting
Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients
Neuromuscular Blockade, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Blocking Agents, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01152905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2010.