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Completed

NCT Number: NCT01327677

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

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.

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

See brief summary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl

Drug

25-50 mcg every 20 minutes

Other names: Fentanyl PRN

Primary outcomes

  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 outcomes

  1. Hypoxia

    Time frame: up to 24 hours postoperatively

    Defined by minimum oxygen saturation (SaO2)

Other outcomes

  1. Mean Fentanyl Consumption

    Time frame: up to 24 hours postoperatively

    Amount of cumulative fentanyl consumed in mcg

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Post Craniotomy Analgesia Safety Monitoring With ET CO2

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2011
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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