Skull Pin InsertionNCT01056224
Effect of Remifentanil Boluses on Hemodynamics in Skull Pin Insertion
A study testing Remifentanil in people with Skull Pin Insertion and Short Duration Analgesia, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Skull Pin Insertion, Short Duration Analgesia
- What is being tested?
- Remifentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteCanada
- Study dates
- May 2005to Jan 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients requiring skull pin fixation and general anesthesia for:
- Elective cervical spine surgery
- Elective craniotomies/brain tumor resection
- Elective transsphenoidal pituitary hypophysectomies
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Dose Effects of Remifentanil Boluses on the Hemodynamic Response to Skull Pin Insertion.
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.
Read the detailed description
Skull pin insertion is commonly required for craniotomies and cervical spine surgery. It is a brief but highly stimulating maneuver performed following induction, during a period of light anesthesia, and may cause significant rise in blood pressure, heart rate and intracranial pressure if not anticipated and treated.
A wide variety of methods have been shown to be effective at blunting this hypertensive response. These include intravenous agents such as fentanyl, sufentanil, clonidine, ketamine and magnesium sulphate, local anesthetic methods such as injection at pin sites or full scalp blocks, deepening the volatile agent, oral premedication or a combination of these methods. There is no consensus on which of these methods is the best. Many anesthesiologists simply use boluses of propofol - a reliable way of accomplishing this effect with a familiar drug. It is also very common for anesthesiologists to use remifentanil, by increasing the infusion rate and or bolusing.
Remifentanil is an ultra-short acting opiate with such rapid onset and offset, that it is most easily and safely delivered by infusion. Increasingly in the literature, however, are reports of remifentanil administered as boluses rather than infusions. Boluses may be ideal for very short stimulating procedures such as intubation and skull pin fixation where a quick onset and offset are desired. Although the safety of bolusing remifentanil has been established in many studies , some authors are still apprehensive . Care must be taken to avoid bolusing with greater doses than required since this may lead to bradycardia and hypotension. In non-ventilated patients, respiratory depression is common and chest wall rigidity may occur at doses larger than 4ug/kg9.
Different bolus dose-effect studies have recommended the following for remifentanil in a variety of clinical settings:
- 3-5ug/kg with propofol 2mg/kg for intubation without muscle relaxants ,
- 2ug/kg with propofol TCI (>4ug/ml) and cisatracurium for intubation (no additional hemodynamic benefit using 4ug/kg)
- 1-1.25ug/kg for rapid sequence intubation with thiopentone 5-7mg/kg and succinylcholine 1mg/kg
- ED50 of 1.7ug/kg and ED95 of 2.88ug/kg for good to excellent intubating conditions in both infants and children (when used with 10ug/kg glycopyrrolate and 4mg/kg propofol)
- 3ug/kg (plus 4mg/kg propofol) provides similar intubating conditions when used in place of succinylcholine 2mg/kg for intubation in infants8
Remifentanil is not currently recommended for the following settings:
- As a sole agent for loss of consciousness with a high ED50 of 12ug/kg, lack of reliability and muscle rigidity common at such high doses
- Wide interindividual variability limit its use for labor analgesia (0.2-0.8ug/kg, median dose of 0.4ug/kg)
In neurosurgery, it is common to administer remifentanil as an infusion. Optimal infusion rates have already been investigated for intracranial surgery . However it is increasingly common to administer remifentanil as a bolus particularly during skull pin fixation, due to the desirable quick onset and offset, and there are no studies at present that have investigated optimal dose requirements for boluses in this setting.
At our institution we commonly administer remifentanil as a bolus during skull pin fixation and are interested in determining which bolus doses are safe and effective
- Conditions
- Skull Pin Insertion, Short Duration Analgesia
- Being tested
- Remifentanil
- Keywords
- skull pin insertion, remifentanil, short acting opioid, craniotomy, cervical spine surgery, hemodynamic changes, dose requirement, age related
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifentanilDrug
A single bolus dose of Remifentanil will be administered at the time of skull pin insertion
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the safety and effectiveness of using remifentanil as a bolus for skull pin fixation
Measured: 10 minutes
Secondary outcomes (4)
To determine the optimal doses for remifentanil in order to blunt the hemodynamic changes associated with skull pin fixation
Measured: 10 minutes
to assess variability in dose requirements of remifentanil
Measured: 10 minutes
to compare the dose effects in younger (20-40yo) vs. older (65-75yo) age groups
Measured: 10 minutes
to compare the dose effects in older (65-75yo) age groups in hypertensive versus non-hypertensive patients
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2010 (estimated)
- Study startMay 2005
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull Pin InsertionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Atul Prabhu, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01056224
- Sponsor's protocol ID
- 05-0684-B
- Status last verified
- Jan 2010
- First submitted
- 22 Jan 2010
- Last updated
- 26 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Dose Effects of Remifentanil Boluses on the Hemodynamic Response to Skull Pin Insertion.
- ClinicalTrials.gov ID
- NCT01056224
- Acronym / sponsor ID
- 05-0684-B
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 26 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Skull pin insertion is commonly required for craniotomies and cervical spine surgery. It is a brief but highly stimulating maneuver performed following induction, during a period of light anesthesia, and may cause significant rise in blood pressure, heart rate and intracranial pressure if not anticipated and treated.
A wide variety of methods have been shown to be effective at blunting this hypertensive response. These include intravenous agents such as fentanyl, sufentanil, clonidine, ketamine and magnesium sulphate, local anesthetic methods such as injection at pin sites or full scalp blocks, deepening the volatile agent, oral premedication or a combination of these methods. There is no consensus on which of these methods is the best. Many anesthesiologists simply use boluses of propofol - a reliable way of accomplishing this effect with a familiar drug. It is also very common for anesthesiologists to use remifentanil, by increasing the infusion rate and or bolusing.
Remifentanil is an ultra-short acting opiate with such rapid onset and offset, that it is most easily and safely delivered by infusion. Increasingly in the literature, however, are reports of remifentanil administered as boluses rather than infusions. Boluses may be ideal for very short stimulating procedures such as intubation and skull pin fixation where a quick onset and offset are desired. Although the safety of bolusing remifentanil has been established in many studies , some authors are still apprehensive . Care must be taken to avoid bolusing with greater doses than required since this may lead to bradycardia and hypotension. In non-ventilated patients, respiratory depression is common and chest wall rigidity may occur at doses larger than 4ug/kg9.
Different bolus dose-effect studies have recommended the following for remifentanil in a variety of clinical settings:
- 3-5ug/kg with propofol 2mg/kg for intubation without muscle relaxants ,
- 2ug/kg with propofol TCI (>4ug/ml) and cisatracurium for intubation (no additional hemodynamic benefit using 4ug/kg)
- 1-1.25ug/kg for rapid sequence intubation with thiopentone 5-7mg/kg and succinylcholine 1mg/kg
- ED50 of 1.7ug/kg and ED95 of 2.88ug/kg for good to excellent intubating conditions in both infants and children (when used with 10ug/kg glycopyrrolate and 4mg/kg propofol)
- 3ug/kg (plus 4mg/kg propofol) provides similar intubating conditions when used in place of succinylcholine 2mg/kg for intubation in infants8
Remifentanil is not currently recommended for the following settings:
- As a sole agent for loss of consciousness with a high ED50 of 12ug/kg, lack of reliability and muscle rigidity common at such high doses
- Wide interindividual variability limit its use for labor analgesia (0.2-0.8ug/kg, median dose of 0.4ug/kg)
In neurosurgery, it is common to administer remifentanil as an infusion. Optimal infusion rates have already been investigated for intracranial surgery . However it is increasingly common to administer remifentanil as a bolus particularly during skull pin fixation, due to the desirable quick onset and offset, and there are no studies at present that have investigated optimal dose requirements for boluses in this setting.
At our institution we commonly administer remifentanil as a bolus during skull pin fixation and are interested in determining which bolus doses are safe and effective
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 1.25 ug/kg normo-tensive 20-40 year olds | Experimental | Drug: RemifentanilA 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. |
| 1.5 ug/kg normo-tensive 20-40 year olds | Experimental | Drug: RemifentanilA 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. |
| 1.75 ug/kg normo-tensive 20-40 year olds | Experimental | Drug: RemifentanilA 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. |
| 1 ug/kg normo-tensive 65-75 year olds | Experimental | Drug: RemifentanilA 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. |
| 1.25 ug/kg normo-tensive 65-75 year olds | Experimental | Drug: RemifentanilA 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. |
| 1.5 ug/kg normo-tensive 65-75 year olds | Experimental | Drug: Remifentanil1.5 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. |
| 1 ug/kg hyper-tensive 65-75 year olds | Experimental | Drug: RemifentanilA 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. |
| 1.25 ug/kg hyper-tensive 65-75 year olds | Experimental | Drug: RemifentanilA 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. |
| 1.5 ug/kg hyper-tensive 65-75 year olds | Experimental | Drug: RemifentanilA 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective cervical spine surgery
- Elective craniotomies/brain tumor resection
- Elective transsphenoidal pituitary hypophysectomies
Key exclusion criteria (4 listed)
- GSC < 15
- Radiological evidence of significant rise in ICP (e.g. midline shift)
- Vascular anomalies in the brain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifentanilA single bolus dose of Remifentanil will be administered at the time of skull pin insertion | Drug | 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 |
Primary outcome
To validate the safety and effectiveness of using remifentanil as a bolus for skull pin fixation
Time frame: 10 minutes
4 secondary outcomes
To determine the optimal doses for remifentanil in order to blunt the hemodynamic changes associated with skull pin fixation
Time frame: 10 minutes
to assess variability in dose requirements of remifentanil
Time frame: 10 minutes
to compare the dose effects in younger (20-40yo) vs. older (65-75yo) age groups
Time frame: 10 minutes
to compare the dose effects in older (65-75yo) age groups in hypertensive versus non-hypertensive patients
Time frame: 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Prabhu, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remifentanil in people with Skull Pin Insertion and Short Duration Analgesia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the safety and effectiveness of using remifentanil as a bolus for skull pin fixation (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2010.