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

Post Craniotomy Analgesia Safety Monitoring With ET CO2

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Fentanyl; Drug: Fentanyl

Detailed Description

See brief summary

• Study Type: Interventional
• Enrollment (Actual): 137
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • The Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Fentanyl PRN; Drug: Fentanyl; 20mcg/demand dose with an 8 minute lock out; Other Names: Fentanyl PCA
Active Comparator: Intravenous Patient-controlled Analgesia (IVPCA) fentanyl; Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.	Drug: Fentanyl; 25-50 mcg every 20 minutes; Other Names: Fentanyl PRN; Drug: Fentanyl; 20mcg/demand dose with an 8 minute lock out; Other Names: Fentanyl PCA

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Fentanyl Consumption	Amount of cumulative fentanyl consumed in mcg	up to 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Athir H Morad, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 25, 2011
• First Submitted That Met QC Criteria: March 31, 2011
• First Posted (Estimate): April 1, 2011

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: safety; craniotomy; pain management; opioid analgesic therapy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: NA_00029336

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO