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

February 25, 2017 updated by: d sessler, The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1584

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must have surgery in G operating room suite

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital Length of Stay
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
up to 72 hours after surgery
Total Intraoperative Opioid Consumption
Time Frame: intraoperative
Total amount of opioid in IV morphine equivalents used during surgeyr
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Daniel I Sessler, MD, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

June 17, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (Estimate)

June 23, 2011

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

February 25, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-440

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Duration of Hospitalization

Clinical Trials on Isoflurane

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United States

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe