Post Craniotomy Analgesia Safety Monitoring With ET CO2
Overview
- Phase
- Phase 4
- Intervention
- Fentanyl
- Conditions
- Pain
- Sponsor
- Johns Hopkins University
- Enrollment
- 137
- Locations
- 1
- Primary Endpoint
- Respiratory Depression
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
See brief summary
Investigators
Eligibility Criteria
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
Arms & Interventions
Pro re nata (PRN) fentanyl
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.
Intervention: Fentanyl
Intravenous Patient-controlled Analgesia (IVPCA) fentanyl
Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.
Intervention: Fentanyl
Outcomes
Primary Outcomes
Respiratory Depression
Time Frame: Up to 24 hours postoperatively.
Defined by maximal End Tidal CO2 (mmHg)
Secondary Outcomes
- Hypoxia(up to 24 hours postoperatively)