The Effect of Propofol and Remifentanil Sequence on ED50 and ED95 of Rocuronium in Rapid Sequence Induction Anesthesia

NCT02709473 | Completed Phase 4

• 1 other identifier: 31-31412
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 2

Brief Summary

Rapid sequence induction (RSI) is a well-known procedure to maintain a safe and rapid airway in patients especially at risk of aspiration. Propofol and rocuronium are generally used agents for RSI. However, the difficult airway scenarios are always valid for these patients, even without predictive signs of difficult airway. Therefore, it is important to decrease the rocuronium dose used in RSI to achieve a rapid recovery of a neuromuscular conduction with the aid of a reversal agent in case of difficult airway. The short acting opioids such as remifentanil may be helpful to reduce the dose of rocuronium in RSI.

Conditions

Anesthesia; Neuromuscular Blockade

Keywords

propofol; remifentanil; rocuronium

Outcome Measures

Primary Outcomes (2)

• ED50 of rocuronium

  ED50 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 50% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED50 of rocuronium will be calculated as means of drug dosage that providing acceptable intubation condition.

  One minute after rocuronium injection

• ED95 of rocuronium

  ED595 of rocuronium means the dose of rocuronium that is required for providing acceptable intubation conditions in the 95% of patients undergoing intubation. Each individual dose that allow or not allow an acceptable intubation condition will determine the next patient rocuronium dose. At the end, ED95 of rocuronium will be estimated by using statistical tools such as pava estimator or R code.

  One minute after rocuronium injection

Secondary Outcomes (1)

• mean arterial blood pressure

  before and after 10 minutes of induction of anesthesia

Study Arms (2)

propofol

ACTIVE COMPARATOR

Propofol arm includes patients that induction of general anesthesia started with propofol and followed by remifentanil and rocuronium administration

Drug: Propofol; Drug: Remifentanil; Drug: Rocuronium

remifentanil

ACTIVE COMPARATOR

Remifentanil arm include patients that induction of general anesthesia started with remifentanil and followed by propofol and rocuronium administration

Drug: Propofol; Drug: Remifentanil; Drug: Rocuronium

Interventions

Propofol DRUG

Propofol will be used in either two arms. The injection sequence will be changed. In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds. And, then remifentanil will be given. In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection.

propofol; remifentanil

Remifentanil DRUG

Remifentanil will be used in either two arms. The injection sequence will be changed. In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds. And then propofol will be given. In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration.

Also known as: Ultiva

propofol; remifentanil

Rocuronium DRUG

Rocuronium will be used for either two study arms. Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject. And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient. Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient. This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation).

Also known as: Esmeron

propofol; remifentanil

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II patients
• patients scheduled for elective surgery

You may not qualify if:

• suspected or known difficult airway
• a significant renal or hepatic dysfunction
• a known neuromuscular disease
• hypertension
• a known allergy to one of the drugs used in general anesthesia
• a body mass index lower than 18.5 kg/m2 or higher than 30 kg/m2
• intake of any medication that might interact with rocuronium
• patient refusal

Sponsors & Collaborators

• Ankara University: lead

Study Sites (2)

Ankara University

Ankara, Turkey (Türkiye)

Location

Harran University

Sanliurfa, Turkey (Türkiye)

Location

Related Publications (3)

• Oh AY, Cho SJ, Seo KS, Ryu JH, Han SH, Hwang JW. Dose of rocuronium for rapid tracheal intubation following remifentanil 2 mug kg-1 and propofol 2 mg kg-1. Eur J Anaesthesiol. 2013 Sep;30(9):550-5. doi: 10.1097/EJA.0b013e3283622ba0.

  PMID: 23698704 BACKGROUND

• Na HS, Hwang JW, Park SH, Oh AY, Park HP, Jeon YT, Do SH. Drug-administration sequence of target-controlled propofol and remifentanil influences the onset of rocuronium. A double-blind, randomized trial. Acta Anaesthesiol Scand. 2012 May;56(5):558-64. doi: 10.1111/j.1399-6576.2012.02648.x. Epub 2012 Feb 7.

  PMID: 22313514 BACKGROUND

• Dewhirst E, Tobias JD, Martin DP. Propofol and remifentanil for rapid sequence intubation in a pediatric patient at risk for aspiration with elevated intracranial pressure. Pediatr Emerg Care. 2013 Nov;29(11):1201-3. doi: 10.1097/PEC.0b013e3182aa136d.

  PMID: 24196089 BACKGROUND

MeSH Terms

Interventions

Propofol; Remifentanil; Rocuronium

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Ozlem Can, Assoc Prof

  Ankara University Department of Anesthesiology and Intensive Care Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 23, 2016
• First Posted: March 16, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 12, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)