Trial Outcomes & Findings for Propofol Versus Sevoflurane Recovery After Gynecological Surgery (NCT NCT01755234)
NCT ID: NCT01755234
Last Updated: 2016-03-14
Results Overview
Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
24 hours after the surgical procedure
Results posted on
2016-03-14
Participant Flow
Subjects were recruited 12/2012-04/2014. 101 subjects were assessed for eligibility, 4 did not meet inclusion criteria and 7 declined to participate. 90 subjects were randomized.
Participant milestones
| Measure |
Sevoflurane
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
30
|
37
|
|
Overall Study
NOT COMPLETED
|
15
|
8
|
Reasons for withdrawal
| Measure |
Sevoflurane
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
6
|
|
Overall Study
Change in surgical case
|
2
|
1
|
|
Overall Study
case cancelled
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
unblinded
|
1
|
0
|
Baseline Characteristics
Propofol Versus Sevoflurane Recovery After Gynecological Surgery
Baseline characteristics by cohort
| Measure |
Sevoflurane
n=45 Participants
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
n=45 Participants
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
45 participants
n=7 Participants
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the surgical procedureQuality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.
Outcome measures
| Measure |
Sevoflurane
n=30 Participants
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
n=37 Participants
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
|---|---|---|
|
Quality of Recovery Score 24 Hours Post Operative
|
175 units on a scale
Interval 163.0 to 181.0
|
176 units on a scale
Interval 163.0 to 184.0
|
SECONDARY outcome
Timeframe: PACU admission to dischargeTotal opioid use in the post operative care unit (Mg of morphine equivalents)
Outcome measures
| Measure |
Sevoflurane
n=30 Participants
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
n=37 Participants
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
|---|---|---|
|
Mg of Morphine Equivalents (IV)
|
9 miligrams of morphine equivalents
Interval 4.0 to 17.0
|
9.4 miligrams of morphine equivalents
Interval 5.0 to 17.0
|
SECONDARY outcome
Timeframe: Time in the post anesthesia care unitNumeric rating scale for pain on a scale of 0-10 (0 is no pain and 10 is high pain) versus time curve in the post anesthesia care unit ( score \* min). A higher value indicates more pain and time in the Post Anesthesia Care Unit. The range is 0 pain to x time in minutes x 1 hour to 5 hour ( 60-300 minutes) . The pain scores were collected at 15 minute intervals from the time of admission to the PACU. The area under the NRS pain scale versus time curve was calculated using the trapezoidal method as an indicator of pain burden during early recovery (Graph Pad Prism ver 5.03, Graph Pad Software INC.
Outcome measures
| Measure |
Sevoflurane
n=30 Participants
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
n=37 Participants
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
|---|---|---|
|
Pain in Post Anesthesia Care Unit
|
270 Pain Score * minutes in PACU
Interval 195.0 to 330.0
|
240 Pain Score * minutes in PACU
Interval 165.0 to 330.0
|
SECONDARY outcome
Timeframe: Discharge from PACU to 24 hours post operative after PACU discharge.Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.
Outcome measures
| Measure |
Sevoflurane
n=30 Participants
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
n=37 Participants
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
|---|---|---|
|
Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.
|
30 mg morphine equivalents
Interval 10.0 to 40.0
|
25 mg morphine equivalents
Interval 0.0 to 40.0
|
Adverse Events
Sevoflurane
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Propofol
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sevoflurane
n=30 participants at risk
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)
Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
|
Propofol
n=37 participants at risk
Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
43.3%
13/30 • Number of events 13 • Time in the post anesthesia care unit.
Nausea experienced in the post anesthesia care unit
|
29.7%
11/37 • Number of events 11 • Time in the post anesthesia care unit.
Nausea experienced in the post anesthesia care unit
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
3/30 • Number of events 3 • Time in the post anesthesia care unit.
Nausea experienced in the post anesthesia care unit
|
2.7%
1/37 • Number of events 1 • Time in the post anesthesia care unit.
Nausea experienced in the post anesthesia care unit
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place