NCT01379664

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,584

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2011

Completed
8 days until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

April 10, 2017

Completed
Last Updated

April 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

June 17, 2011

Results QC Date

November 29, 2016

Last Update Submit

February 25, 2017

Conditions

Keywords

SevofluraneIsofluranevolatile anestheticduration of hospitalization

Outcome Measures

Primary Outcomes (1)

  • Hospital Length of Stay

    participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcomes (2)

  • Time-weighted Average Verbal Rating Pain Score

    up to 72 hours after surgery

  • Total Intraoperative Opioid Consumption

    intraoperative

Study Arms (2)

Isoflurane

EXPERIMENTAL

Isoflurane is to be administered to patients in this arm during surgery

Drug: Isoflurane

Sevoflurane

EXPERIMENTAL

Sevoflurane is to be administered to patients in this arm during surgery

Drug: Sevoflurane

Interventions

Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist

Isoflurane

Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist

Sevoflurane

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Must have surgery in G operating room suite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

IsofluraneSevoflurane

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbons

Results Point of Contact

Title
Daniel Sessler
Organization
Cleveland Clinic Foundation

Study Officials

  • Daniel I Sessler, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Chair

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 23, 2011

Study Start

July 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 10, 2017

Results First Posted

April 10, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations