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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01379664
Other study ID # 11-440
Secondary ID
Status Recruiting
Phase N/A
First received June 17, 2011
Last updated March 14, 2013
Start date July 2011
Est. completion date December 2013

Study information

Verified date March 2013
Source The Cleveland Clinic
Contact Gretchen Upton
Phone 216-444-3289
Email uptong@ccf.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 4150
Est. completion date December 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Must have surgery in G operating room suite

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Cleveland Clinic Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital Length of Stay participants will be followed for the duration of hospital stay, an expected average of 3 days No
Secondary Pain scores pain scores are greater in patients recovering from isoflurane than sevoflurane anesthesia up to 3 days after surgery No
Secondary opiod consumption opioid consumption is greater after isoflurane than sevoflurane anesthesia up to 3 days after surgery No
See also
  Status Clinical Trial Phase
Completed NCT05222113 - OBSERVATIONAL STUDY OF COMPARISON EFFECTIVITY BETWEEN REMDESIVIR AND FAVIPIRAVIR IN SURABAYA, INDONESIA