Study of Rocuronium Onset Time According to Remifentanil Infusion

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: the order of drug administration

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group R; In group R, remifentanil was infused first before administrating propofol and rocuronium	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.; Other Names: ultiva; esmeron; fresopol
Active Comparator: group P; in group P, remifentanil was administered last after the propofol and rocuronium injection	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.; Other Names: ultiva; esmeron; fresopol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.]
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.]
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.]
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.]
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.]

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 10, 2009
• First Submitted That Met QC Criteria: December 10, 2009
• First Posted (Estimate): December 11, 2009

Study Record Updates

• Last Update Posted (Estimate): December 16, 2011
• Last Update Submitted That Met QC Criteria: December 14, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: TIVA_rocu