Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring

Study Overview
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Brief Summary
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This research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. Both of these methods are available in the postoperative treatment of pain. This research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

Detailed Description
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See brief summary

Official Title
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Post Craniotomy Analgesia Safety Monitoring With ET CO2

Conditions
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Pain

Intervention / Treatment
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* Drug: Fentanyl
* Drug: Fentanyl


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male and female, English speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the Johns Hopkins Hospital will be eligible for this study. Exclusion Criteria: pregnant women patients with post operative neurological changes patients who remain intubated post-operatively patients who require the use of concomitant administration of sedatives patients who are unable to initiate a PCA bolus patients who are unable to communicate verbally patients who are allergic to fentanyl patients who have a history of narcotic abuse patients who have a history of chronic pain requiring opioids patients who have been in any investigational drug trial within 1 month of the treatment day patients who have chronic respiratory insufficiency

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pro re nata (PRN) fentanyl<br>A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain. | Drug: Fentanyl<br>* 25-50 mcg every 20 minutes<br>* Other names: Fentanyl PRN;|
| Active Comparator: Intravenous Patient-controlled Analgesia (IVPCA) fentanyl<br>Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump. | Drug: Fentanyl<br>* 20mcg/demand dose with an 8 minute lock out<br>* Other names: Fentanyl PCA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Depression | Defined by minimum respiratory rate (breaths/minute). | up to 24 hours postoperatively | 
| Respiratory Depression | Defined by maximal End Tidal CO2 (mmHg) | Up to 24 hours postoperatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxia | Defined by minimum oxygen saturation (SaO2) | up to 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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safety, pain management, opioid analgesic therapy, craniotomy