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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Fentanyl

• Registration Number: NCT01327677
• Lead Sponsor: 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.

Detailed Description

See brief summary

Study Timeline

• Study First Submitted: 2011-03-25
• Study First Submitted QC: 2011-03-31
• Study First Posted: 2011-04-01
• Study Start: 2011-05
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2017-03-09
• Status Verified: 2017-05
• Results First Submitted QC: 2017-05-02
• Last Update Submitted: 2017-05-02
• Results First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pro re nata (PRN) fentanyl	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.
Intravenous Patient-controlled Analgesia (IVPCA) fentanyl	Fentanyl	Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.

Primary Outcome Measures

Name	Time	Method
Respiratory Depression	Up to 24 hours postoperatively.	Defined by maximal End Tidal CO2 (mmHg)

Secondary Outcome Measures

Name	Time	Method
Hypoxia	up to 24 hours postoperatively	Defined by minimum oxygen saturation (SaO2)

Trial Locations

Locations (1)

The Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States