Study of Rocuronium Onset Time According to Remifentanil Infusion

Anesthesia Clinical Trial

Official title:

The Effect of Remifentanil on the Onset Time of Rocuronium in Total Intravenous Anesthesia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030510
• Other study ID #: TIVA_rocu
• Status: Completed
• Phase: N/A
• First received: December 10, 2009
• Last updated: December 14, 2011
• Start date: December 2009
• Est. completion date: October 2010

Study information

• Verified date: December 2011
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The investigators therefore hypothesized that remifentanil could prolong the onset time of rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial pressure and heart rate) during the anesthetic induction sequence.

Description:

It has been reported that co-administration of ephedrine reduced the onset time of neuromuscular block of rocuronium (1-3). It also provided an improved condition for the rapid tracheal intubation (2,4). This beneficial effect was attributed to the increased cardiac output and tissue perfusion to muscle, and therefore, a more rapid delivery of rocuronium to the neuromuscular junction was achieved (4-5). If so, any drugs which decrease cardiac output consequently can prolong the onset time of rocuronium.

Remifentanil is the first ultra-short acting opioid with a rapid onset. During the total intravenous anesthesia (TIVA) with propofol and remifentanil, prior administration of remifentanil could reduce the propofol infusion pain without other significant complications (6). However, remifentanil can decrease the arterial pressure and heart rate (7-8), so that it is likely to decrease the onset time of rocuronium for the opposite principle that ephedrine increases it.

The investigators therefore hypothesized that remifentanil could prolong the onset time of rocuronium, and evaluated the effect of remifentanil on the hemodynamic profiles (arterial pressure and heart rate) during the anesthetic induction sequence.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion criteria:

• American Society of Anesthesiologist physical status I or II

• Aged 20-65 yr

• Elective surgery under general anesthesia with total intravenous anesthesia

• 8.5 kg/m2 < body mass index (BMI) < 25 kg/m2

Exclusion criteria:

• BMI > 25 kg/m2 or < 18.5 kg/m2

• Any cardiovascular or neuromuscular disease

• Intake of drugs known to interact with the neuromuscular junction

• Patients wit risk of pulmonary aspiration

• Anticipated difficult airway

• history of known allergy to rocuronium

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• the order of drug administration
In group R, remifentanil was infused first before administrating propofol and rocuronium and in group P, it was administered last after the rocuronium injection. In other words, the order of drug infusion in each group is remifentanil-propofol-rocuronium in group R and propofol-rocuronium-remifentanil in group P, respectively.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the onset time of rocuronium	Onset time of rocuronium was defined as the time from the end of its injection to the 95% depression of single twitch response, and it was measured by an anaesthesiologist, unaware of the group allocation.	3 minutes [after injection of rocuronium when general anesthesia is induced.]	No
Secondary	mean arterial pressure (MAP)	before induction (baseline): When a patient enter the operating room,; at rocuronium administration: immediately before injecting rocuronium,; before tracheal intubation: immediately before intubation,; after tracheal intubation: immediately after intubation.	15 minutes [4 times; during the induction of general anesthesia as described below.]	No
Secondary	heart rate (HR)	before induction (baseline): When a patient enter the operating room,; at rocuronium administration: immediately before injecting rocuronium,; before tracheal intubation: immediately before intubation,; after tracheal intubation: immediately after intubation.	15 minutes [4 times; during the induction of general anesthesia as described below.]	No
Secondary	cardiac output	before induction (baseline): When a patient enter the operating room,; at rocuronium administration: immediately before injecting rocuronium,; before tracheal intubation: immediately before intubation,; after tracheal intubation: immediately after intubation.	15 minutes [4 times; during the induction of general anesthesia as described below.]	No
Secondary	pain from the propofol infusion	When propofol is administered for the induction of anesthesia, we investigate the pain by propofol.	1 minute [at the time when propofol is administered.]	No
Secondary	cough or chest wall rigidity from the remifentanil infusion	when remifentanil is infused, the cough or chest wall rigidity is checked.	1 minute [at the time when remifentanil is infused.]	Yes