Trial Outcomes & Findings for Volatile Anesthetic Choice and Duration of Hospitalization: A Quality Improvement and Cost-control Project (NCT NCT01379664)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1584 participants

Primary outcome timeframe

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

Results posted on

2017-04-10

Participant Flow

Participant milestones

Participant milestones
Measure	Isoflurane Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist	Sevoflurane Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Overall Study STARTED	714	870
Overall Study COMPLETED	714	870
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Isoflurane n=714 Participants Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist	Sevoflurane n=870 Participants Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist	Total n=1584 Participants Total of all reporting groups
Age, Continuous	53.4 years STANDARD_DEVIATION 16.5 • n=5 Participants	53.6 years STANDARD_DEVIATION 16.6 • n=7 Participants	53.5 years STANDARD_DEVIATION 16.6 • n=5 Participants
Sex: Female, Male Female	408 Participants n=5 Participants	502 Participants n=7 Participants	910 Participants n=5 Participants
Sex: Female, Male Male	306 Participants n=5 Participants	368 Participants n=7 Participants	674 Participants n=5 Participants

PRIMARY outcome

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

Outcome measures

Outcome measures
Measure	Isoflurane n=714 Participants Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist	Sevoflurane n=870 Participants Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Hospital Length of Stay	4.9 Days Interval 2.0 to 8.4	4.4 Days Interval 1.5 to 7.8

SECONDARY outcome

Timeframe: up to 72 hours after surgery

Population: Postoperative pain measurements were not available for 19 isoflurane patients and 20 sevoflurane patients.

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).

Outcome measures

Outcome measures
Measure	Isoflurane n=682 Participants Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist	Sevoflurane n=850 Participants Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Time-weighted Average Verbal Rating Pain Score	3.6 units on a scale Standard Deviation 1.9	3.6 units on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: intraoperative

Total amount of opioid in IV morphine equivalents used during surgeyr

Outcome measures

Outcome measures
Measure	Isoflurane n=714 Participants Isoflurane is to be administered to patients in this arm during surgery Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist	Sevoflurane n=870 Participants Sevoflurane is to be administered to patients in this arm during surgery Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
Total Intraoperative Opioid Consumption	32 mg Standard Deviation 1.3	33 mg Standard Deviation 1.6

Adverse Events

Isoflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sevoflurane

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Sessler

Cleveland Clinic Foundation

Phone: 216-444-4900

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place