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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327677
Recruitment Status : Completed
First Posted : April 1, 2011
Results First Posted : May 31, 2017
Last Update Posted : May 31, 2017
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Pain Drug: Fentanyl Phase 4

Detailed Description:
See brief summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post Craniotomy Analgesia Safety Monitoring With ET CO2
Study Start Date : May 2011
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01327677

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

Responsible Party: Johns Hopkins University Identifier: NCT01327677     History of Changes
Other Study ID Numbers: NA_00029336
First Posted: April 1, 2011    Key Record Dates
Results First Posted: May 31, 2017
Last Update Posted: May 31, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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