Surgery
Conditions
Keywords
hemodynamic stability, remifentanil
Brief summary
To identify a better method using a combination of routine anesthetic drugs to improve hemodynamic stability during Mayfield head pinning for craniotomy surgery.
Detailed description
A randomized, placebo-controlled, double-blinded comparative effectiveness study to test hypothesis that addition of remifentanil bolus to a standard anesthetic drug regimen will better attenuate the hemodynamic response to the noxious stimulus of Mayfield head pin insertion than the standard anesthetic drug regimen.
Interventions
DRUGRemifentanil
Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered
DRUGNormal Saline
Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult non-pregnant patients * undergoing general anesthesia for a craniotomy * requiring a Mayfield head fixation device.
Exclusion criteria
* Patients under 18 years of age, * non-English speaking, * pregnancy, * opioid tolerance, * illegal drug use or alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Arterial Blood Pressure After Head Fixation | Ten minute window after head fixation |
Secondary
| Measure | Time frame |
|---|---|
| Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations | 10 minute window after head fixation |
Countries
United States
Participant flow
Recruitment details
Northwestern Memorial Hospital Ambulatory Surgery Unit or equivalent location where preoperative anesthesia evaluation occurring.
Participants by arm
| Arm | Count |
|---|---|
| Remifentanil Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning. | 10 |
| Normal Saline Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Placebo | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Remifentanil | Normal Saline | Total |
|---|---|---|---|
| Age, Continuous | 61.3 years STANDARD_DEVIATION 12.2 | 51.7 years STANDARD_DEVIATION 4.8 | 56.5 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 10 | 8 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Mean Arterial Blood Pressure After Head Fixation
Time frame: Ten minute window after head fixation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Remifentanil | Mean Arterial Blood Pressure After Head Fixation | 76 mm Hg | Standard Deviation 8 |
| Normal Saline | Mean Arterial Blood Pressure After Head Fixation | 83 mm Hg | Standard Deviation 12 |
p-value: 0.0575t-test, 2 sided
Secondary
Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations
Time frame: 10 minute window after head fixation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Remifentanil | Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations | 5 participants |
| Normal Saline | Number of Patients Requiring Rescue Therapy for Hemodynamic Perturbations | 8 participants |
p-value: 0.348t-test, 2 sided