Rocuronium Dose Finding Study After Single-shot or Steady-state Propofol Anesthesia

NCT02054468 | Completed DMC

• 1 other identifier: ROSANNA
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine the effective-doses ED-50 and ED-95 (the doses required for a 50% and 95% twitch inhibition, respectively) of the non-depolarizing muscle relaxant rocuronium after single-shot or steady-state propofol anesthesia in a clinical setting.

Conditions

Neuromuscular Blockade; Anesthesia

Keywords

Muscle relaxant, Rocuronium, TIVA, Propofol

Outcome Measures

Primary Outcomes (2)

• ED-50 of rocuronium

  The primary outcome measure is the 1) ED-50 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia

  Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min

• ED-95 of rocuronium

  The primary outcome measure is 2) the ED-95 of rocuronium during anesthesia induction with propofol and after steady-state propofol anesthesia

  Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min

Secondary Outcomes (1)

• Pharmacodynamics of rocuronium (composite outcome measure)

  Anesthesia time during their surgical procedure (=arrival in the OR until discharge from the post-anesthesia care unit), ca. 180min

Study Arms (2)

Single-shot-Propofol & Remifentanil

ACTIVE COMPARATOR

Induction group: A single-shot propofol induction dose with remifentanil infusion followed by injection of rocuronium (for doses, please see interventions). Airway: tracheal intubation

Drug: Single-Shot Propofol; Drug: Remifentanil infusion; Drug: Rocuronium (0.07mg/kg/body mass); Drug: Rocuronium (0.1mg/kg/body mass); Drug: Rocuronium (0.15mg/kg/body mass); Drug: Rocuronium (0.2mg/kg/body mass); Drug: Rocuronium (0.3mg/kg/body mass); Drug: Rocuronium (0.45mg/kg/body mass)

30min infusion Propofol & Remifentanil

EXPERIMENTAL

Maintenance group: 30min of total intravenous anesthesia (TIVA) with propofol and remifentanil before rocuronium (for doses, please see interventions) is administered. Airway: tracheal intubation/laryngeal mask

Drug: 30min infusion Propofol; Drug: Remifentanil infusion; Drug: Rocuronium (0.07mg/kg/body mass); Drug: Rocuronium (0.1mg/kg/body mass); Drug: Rocuronium (0.15mg/kg/body mass); Drug: Rocuronium (0.2mg/kg/body mass); Drug: Rocuronium (0.3mg/kg/body mass); Drug: Rocuronium (0.45mg/kg/body mass)

Interventions

Single-Shot Propofol DRUG

Single-shot propofol induction dose (1.5-2.5mg/kg body mass)

Also known as: 2,6-Diisopropylphenol

Single-shot-Propofol & Remifentanil

30min infusion Propofol DRUG

30min of propofol infusion (4-6mg/kg/h)

Also known as: 2,6-Diisopropylphenol

30min infusion Propofol & Remifentanil

Remifentanil infusion DRUG

Remifentanil infusion (0.1-0.2µg/kg/min)

Also known as: Ultiva®

30min infusion Propofol & Remifentanil; Single-shot-Propofol & Remifentanil

Rocuronium (0.07mg/kg/body mass) DRUG

Rocuronium (0.07mg/kg/body mass)

Also known as: Esmeron

30min infusion Propofol & Remifentanil; Single-shot-Propofol & Remifentanil

Rocuronium (0.1mg/kg/body mass) DRUG

Rocuronium (0.1mg/kg/body mass)

Also known as: Esmeron

30min infusion Propofol & Remifentanil; Single-shot-Propofol & Remifentanil

Rocuronium (0.15mg/kg/body mass) DRUG

Rocuronium (0.15mg/kg/body mass)

Also known as: Esmeron

30min infusion Propofol & Remifentanil; Single-shot-Propofol & Remifentanil

Rocuronium (0.2mg/kg/body mass) DRUG

Rocuronium (0.2mg/kg/body mass)

Also known as: Esmeron

30min infusion Propofol & Remifentanil; Single-shot-Propofol & Remifentanil

Rocuronium (0.3mg/kg/body mass) DRUG

Rocuronium (0.3mg/kg/body mass)

Also known as: Esmeron

30min infusion Propofol & Remifentanil; Single-shot-Propofol & Remifentanil

Rocuronium (0.45mg/kg/body mass) DRUG

Rocuronium (0.45mg/kg/body mass)

Also known as: Esmeron

30min infusion Propofol & Remifentanil; Single-shot-Propofol & Remifentanil

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for a low risk-surgical procedure under general anesthesia
• Patients ASA physical status I-III
• Patients older than 18years
• Patients having given informed consent to the study

You may not qualify if:

• Patients who decline to give informed consent to the study
• Known or suspected allergy towards anesthetics or rocuronium
• Pregnant and breastfeeding women
• Known or suspected neuromuscular disease
• Burn injury prior to the investigation
• Anatomic and functional malformations with expected difficult intubation
• Anorexia, Bulimia nervosa, Malnutrition
• Heart failure
• Use of drugs that interfere with muscle relaxant

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München

Munich, Bavaria, 81675, Germany

Location

Related Publications (6)

• Naguib M, Seraj M, Abdulrazik E. Pipecuronium-induced neuromuscular blockade during nitrous oxide-fentanyl, enflurane, isoflurane, and halothane anesthesia in surgical patients. Anesth Analg. 1992 Aug;75(2):193-7. doi: 10.1213/00000539-199208000-00007.

  PMID: 1321569 BACKGROUND

• Viby-Mogensen J, Jorgensen BC, Ording H. Residual curarization in the recovery room. Anesthesiology. 1979 Jun;50(6):539-41. doi: 10.1097/00000542-197906000-00014. No abstract available.

  PMID: 156513 BACKGROUND

• Debaene B, Plaud B, Dilly MP, Donati F. Residual paralysis in the PACU after a single intubating dose of nondepolarizing muscle relaxant with an intermediate duration of action. Anesthesiology. 2003 May;98(5):1042-8. doi: 10.1097/00000542-200305000-00004.

  PMID: 12717123 BACKGROUND

• Eikermann M, Blobner M, Groeben H, Rex C, Grote T, Neuhauser M, Beiderlinden M, Peters J. Postoperative upper airway obstruction after recovery of the train of four ratio of the adductor pollicis muscle from neuromuscular blockade. Anesth Analg. 2006 Mar;102(3):937-42. doi: 10.1213/01.ane.0000195233.80166.14.

  PMID: 16492855 BACKGROUND

• Hemmerling TM, Le N, Decarie P, Cousineau J, Bracco D. Total intravenous anesthesia with propofol augments the potency of mivacurium. Can J Anaesth. 2008 Jun;55(6):351-7. doi: 10.1007/BF03021490.

  PMID: 18566198 BACKGROUND

• Robertson EN, Fragen RJ, Booij LH, van Egmond J, Crul JF. Some effects of diisopropyl phenol (ICI 35 868) on the pharmacodynamics of atracurium and vecuronium in anaesthetized man. Br J Anaesth. 1983 Aug;55(8):723-8. doi: 10.1093/bja/55.8.723.

  PMID: 6136286 BACKGROUND

MeSH Terms

Conditions

Muscle Hypotonia

Interventions

Propofol; Remifentanil; Rocuronium

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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

• Manfred Blobner, M.D.

  Klinik für Anaesthesiologie, Klinikum rechts der Isar der Technischen Universität München, Ismaninger Str. 22, 81675 München, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2014
• First Posted: February 4, 2014
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 8, 2014

Record last verified: 2014-05

Locations

DE (1)