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Safety Study of Analgesia After Craniotomy Surgery With End Tidal CO2 Monitoring

This study is currently recruiting participants.
Verified May 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Athir Morad, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01327677
First received: March 25, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  Purpose

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, we want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.


Condition Intervention Phase
Pain
 Drug: Fentanyl
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Post Craniotomy Analgesia Safety Monitoring With ET CO2

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Respiratory rate < 10 breaths per minute for greater than 2 minutes. [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • oxygen saturation <90%, apnea > 30 secs., ET CO2 > 60, need for narcan, excessive somnolence [ Time Frame: up to 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Drug: Fentanyl
25-50 mcg every 20 minutes
Other Name: Non applicable
Active Comparator: IVPCA fentanyl
Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.
 Drug: Fentanyl
20mcg/demand dose with an 8 minute lock out
Other Name: Non applicable

Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • patients who have chronic respiratory insufficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327677

Contacts
Contact: Athir Morad, MD 410-955-7461 morada@jhmi.edu

Locations
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287
Contact: Athir Morad, MD     410-955-2611     morada@jhmi.edu    
Principal Investigator: Athir Morad, MD            
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Athir H Morad, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Athir Morad, Assistant Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01327677     History of Changes
Other Study ID Numbers: NA_00029336
Study First Received: March 25, 2011
Last Updated: May 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
pain management
opioid analgesic therapy
safety
craniotomy

Additional relevant MeSH terms:
Fentanyl
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid

ClinicalTrials.gov processed this record on May 21, 2013