Effect of Remifentanil Boluses on Hemodynamics in Skull Pin Insertion

NCT01056224 | Completed

• 1 other identifier: 05-0684-B
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Skull pin insertion during craniotomies is a brief, intensely stimulating, painful stimuli occurring during the conduct of a neurosurgical or spine anesthetic. Remifentanil is an ultra short acting opioid that has been successfully used to blunt hemodynamic responses in a wide variety of clinical scenarios. It is our intention to ascertain the optimal dose for blunting the hemodynamic response to skull pin insertion using remifentanil.

Conditions

Skull Pin Insertion; Short Duration Analgesia

Keywords

skull pin insertion; remifentanil; short acting opioid; craniotomy; cervical spine surgery; hemodynamic changes; dose requirement; age related

Outcome Measures

Primary Outcomes (1)

• To validate the safety and effectiveness of using remifentanil as a bolus for skull pin fixation

  10 minutes

Secondary Outcomes (4)

• To determine the optimal doses for remifentanil in order to blunt the hemodynamic changes associated with skull pin fixation

  10 minutes

• to assess variability in dose requirements of remifentanil

  10 minutes

• to compare the dose effects in younger (20-40yo) vs. older (65-75yo) age groups

  10 minutes

• to compare the dose effects in older (65-75yo) age groups in hypertensive versus non-hypertensive patients

  10 minutes

Study Arms (9)

1.25 ug/kg normo-tensive 20-40 year olds

EXPERIMENTAL

A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.

Drug: Remifentanil

1.5 ug/kg normo-tensive 20-40 year olds

EXPERIMENTAL

A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.

Drug: Remifentanil

1.75 ug/kg normo-tensive 20-40 year olds

EXPERIMENTAL

A single bolus dose of 1.75 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 20 to 40 years old.

Drug: Remifentanil

1 ug/kg normo-tensive 65-75 year olds

EXPERIMENTAL

A single bolus dose of 1 microgram per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.

Drug: Remifentanil

1.25 ug/kg normo-tensive 65-75 year olds

EXPERIMENTAL

A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.

Drug: Remifentanil

1.5 ug/kg normo-tensive 65-75 year olds

EXPERIMENTAL

1.5 ug/kg normo-tensive 65-75 year olds A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in normo-tensive patients aged 65 to 75 years old.

Drug: Remifentanil

1 ug/kg hyper-tensive 65-75 year olds

EXPERIMENTAL

A single bolus dose of 1 microgram per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.

Drug: Remifentanil

1.25 ug/kg hyper-tensive 65-75 year olds

EXPERIMENTAL

A single bolus dose of 1.25 micrograms per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.

Drug: Remifentanil

1.5 ug/kg hyper-tensive 65-75 year olds

EXPERIMENTAL

A single bolus dose of 1.5 micrograms per kilogram body weight will be administered at the time of skull pin insertion in hyper-tensive patients aged 65 to 75 years old.

Drug: Remifentanil

Interventions

Remifentanil DRUG

A single bolus dose of Remifentanil will be administered at the time of skull pin insertion

1 ug/kg hyper-tensive 65-75 year olds; 1 ug/kg normo-tensive 65-75 year olds; 1.25 ug/kg hyper-tensive 65-75 year olds; 1.25 ug/kg normo-tensive 20-40 year olds; 1.25 ug/kg normo-tensive 65-75 year olds; 1.5 ug/kg hyper-tensive 65-75 year olds; 1.5 ug/kg normo-tensive 20-40 year olds; 1.5 ug/kg normo-tensive 65-75 year olds; 1.75 ug/kg normo-tensive 20-40 year olds

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring skull pin fixation and general anesthesia for:
• Elective cervical spine surgery
• Elective craniotomies/brain tumor resection
• Elective transsphenoidal pituitary hypophysectomies

You may not qualify if:

• Patients with evidence of raised intracranial pressure:
• GSC \< 15
• Radiological evidence of significant rise in ICP (e.g. midline shift)
• Vascular anomalies in the brain

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Interventions

Remifentanil

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Atul Prabhu, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 22, 2010
• First Posted: January 26, 2010
• Study Start: May 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 26, 2010

Record last verified: 2010-01

Locations

CA (1)