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NCT01327677 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Johns Hopkins University.

Completed
Registry status
Phase 4
Development phase
137
Enrollment target

NCT01327677: Completed Phase 4 study, sponsored by Johns Hopkins University.

NCT01327677 is a Phase 4 study that has completed, run by Johns Hopkins University. The registered enrollment target is 137 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01327677, a Phase 4 study, has completed, sponsored by Johns Hopkins University.

COMPLETED
Registry status
Phase 4
Development phase
137 participants
Enrollment target

Study 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.

Primary Outcome

Defined by minimum respiratory rate (breaths/minute).

Interventions

  • DRUG Fentanyl

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2011-05
Est. Completion 2014-05
Phase Phase 4
Johns Hopkins University

1,448 total trials

What the finished NCT01327677 record still lists

NCT01327677 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (74% lower).

The record links to 0 conditions, and to 1 intervention - of which Fentanyl is the first listed.

NCT01327677 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01327677 about?

NCT01327677 is a clinical study titled "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 ...

What is the current status of trial NCT01327677?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 137 participants. The study started on 2011-05. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01327677?

The interventions under investigation include: Fentanyl (DRUG).

Who is sponsoring clinical trial NCT01327677?

This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01327677's enrollment target sits among peer trials

137 594th of 2000 higher than 1,405 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01327677, the US trial registry maintained by the National Library of Medicine. NCT01327677 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.