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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01327677
First received: March 25, 2011
Last updated: May 2, 2017
Last verified: May 2017
  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, The investigators 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
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Post Craniotomy Analgesia Safety Monitoring With ET CO2

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Respiratory Depression [ Time Frame: up to 24 hours postoperatively ]
    Defined by minimum respiratory rate (breaths/minute).

  • Respiratory Depression [ Time Frame: Up to 24 hours postoperatively. ]
    Defined by maximal End Tidal CO2 (mmHg)


Secondary Outcome Measures:
  • Hypoxia [ Time Frame: up to 24 hours postoperatively ]
    Defined by minimum oxygen saturation (SaO2)


Other Outcome Measures:
  • Mean Fentanyl Consumption [ Time Frame: up to 24 hours postoperatively ]
    Amount of cumulative fentanyl consumed in mcg


Enrollment: 137
Study Start Date: May 2011
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Fentanyl
25-50 mcg every 20 minutes
Other Name: Fentanyl PRN
Active Comparator: Intravenous Patient-controlled Analgesia (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: Fentanyl PCA

Detailed Description:
See brief summary
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01327677

Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Athir H Morad, MD Johns Hopkins University
  More Information

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01327677     History of Changes
Other Study ID Numbers: NA_00029336
Study First Received: March 25, 2011
Results First Received: March 9, 2017
Last Updated: May 2, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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

ClinicalTrials.gov processed this record on July 19, 2017