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Volatile Anesthetic Choice and Duration of Hospitalization: A Quality Improvement and Cost-control Project

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ClinicalTrials.gov Identifier: NCT01379664
Recruitment Status : Completed
First Posted : June 23, 2011
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
d sessler, The Cleveland Clinic

Study Description
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Brief Summary:

Preliminary retrospective data suggest that the relatively soluble but inexpensive volatile anesthesia isoflurane prolongs the duration of hospitalization compared to the less soluble but more expensive anesthetic sevoflurane. Even a small reduction in the duration of hospitalization would easily compensate for the modest additional cost of sevoflurane. The investigators therefore propose to test the primary hypothesis that duration of hospitalization is longer with isoflurane than sevoflurane.

The investigators will also test the secondary hypotheses that: 1) pain scores are greater in patients recovering from isoflurane than sevoflurane anesthesia; and, 2) opioid consumption is greater after isoflurane than sevoflurane anesthesia. All statistical analyses will be adjusted for age, gender, race, baseline risk, 9 and procedure.


Condition or disease Intervention/treatment Phase
Duration of Hospitalization Drug: Isoflurane Drug: Sevoflurane Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1584 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Volatile Anesthetic Choice and Duration of Hospitalization: A Quality Improvement and Cost-control Project
Study Start Date : July 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Isoflurane
Isoflurane is to be administered to patients in this arm during surgery
 Drug: Isoflurane
Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Experimental: Sevoflurane
Sevoflurane is to be administered to patients in this arm during surgery
 Drug: Sevoflurane
Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist


Outcome Measures
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Primary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days ]

Secondary Outcome Measures :
  1. Time-weighted Average Verbal Rating Pain Score [ Time Frame: up to 72 hours after surgery ]
    Time-weighted average VRS (Verbal Rating Scale) pain score over the first 72 h after surgery as recorded by nurses at approximately 4-h intervals. The VRS pain score is from 0 (no pain) to 10 (worst imaginable pain).

  2. Total Intraoperative Opioid Consumption [ Time Frame: intraoperative ]
    Total amount of opioid in IV morphine equivalents used during surgeyr


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must have surgery in G operating room suite
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT01379664


Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Daniel I Sessler, MD The Cleveland Clinic
More Information
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Responsible Party: d sessler, Professor & Chair, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01379664    
Other Study ID Numbers: 11-440
First Posted: June 23, 2011    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by d sessler, The Cleveland Clinic:
Sevoflurane
Isoflurane
volatile anesthetic
duration of hospitalization
Additional relevant MeSH terms:
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Sevoflurane
Isoflurane
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs