Study of Rocuronium Onset Time According to Remifentanil Infusion

NCT01030510 | Completed DMC

• 1 other identifier: TIVA_rocu
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• mean arterial pressure (MAP)

  15 minutes [4 times; during the induction of general anesthesia as described below.]

• heart rate (HR)

  15 minutes [4 times; during the induction of general anesthesia as described below.]

• cardiac output

  15 minutes [4 times; during the induction of general anesthesia as described below.]

• pain from the propofol infusion

  1 minute [at the time when propofol is administered.]

• cough or chest wall rigidity from the remifentanil infusion

  1 minute [at the time when remifentanil is infused.]

Study Arms (2)

group R

ACTIVE COMPARATOR

In group R, remifentanil was infused first before administrating propofol and rocuronium

Drug: the order of drug administration

group P

ACTIVE COMPARATOR

in group P, remifentanil was administered last after the propofol and rocuronium injection

Drug: the order of drug administration

Interventions

the order of drug administration DRUG

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.

Also known as: esmeron, ultiva, fresopol

group P; group R

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologist physical status I or II
• Aged 20-65 yr
• Elective surgery under general anesthesia with total intravenous anesthesia
• kg/m2 \< body mass index (BMI) \< 25 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Interventions

Rocuronium; Remifentanil

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 11, 2009
• Study Start: December 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 16, 2011

Record last verified: 2011-12

Locations

KR (1)