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Propofol Versus Sevoflurane Recovery After Gynecological Surgery

The Effects of Propofol vs. Sevoflurane Administered During Anesthesia Maintenance on Early and Late Recovery After Gynecological Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01755234
Enrollment
90
Registered
2012-12-24
Start date
2012-11-30
Completion date
2014-04-30
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Surgery

Keywords

Outpatient, Surgery, Anesthesia

Brief summary

80% of 25 million American who undergo surgery describe moderate to severe pain. The use of multimodal analgesic techniques can attenuate patient's postoperative pain and several different medication have been found to be effective. Pain can significantly affect patient's quality of recovery after surgery. Volatile anesthetics can increase sensitivity to pain at the low concentrations present on emergence from anesthesia. Propofol may have analgesic effect at sedative doses. The effects of propofol,when used for anesthesia maintenance, on postoperative pain have demonstrated controversial results with some investigators showing a potential benefit whereas others have not shown any benefit. Propofol for maintenance of anesthesia has been advocated as an strategy for high risk patients even though it has shown controversial results on reduction of Post operative nausea and vomiting. A comparison of propofol vs.volatile anesthetic in regards to the time required by patients to meet discharge criteria has also shown conflicting results.The QOR 40 is a validated instrument that has been specifically developed to evaluate patients recovery after anesthesia and surgery. The purpose of this study is to compare the effects of maintenance of anesthesia with two agents (Propofol and Sevoflurane) on quality of recovery after ambulatory surgery Significance: the results of this study can lead to the discovery of an anesthesia technique that is associated with a better recovery for patients after ambulatory surgery. Research question is: do patients anesthetized with propofol have a better quality of recovery after ambulatory anesthesia than patients anesthetized with Sevoflurane? The hypothesis: patients anesthetized with propofol will have better quality of recovery than patients anesthetized with Sevoflurane after ambulatory surgery.

Detailed description

Subjects will be recruited up to the day of surgery. 90 subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers: anesthetic maintenance with Sevoflurane or anesthetic maintenance with Propofol . Subjects will be premedicated with intravenous (IV) midazolam 0.04 mg/kg. Routine ASA monitors will be applied. Anesthesia will be induced with remifentanil infusion started at 0.1 mcg/kg/minute titrated to keep blood pressure within 20% of the baseline and propofol 1.0 -2.0 mg/kg or sevoflurane induction. Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg) or succinylcholine (1-2mg /kg). Anesthesia will be maintained with Sevoflurane or a Propofol infusion titrated to keep a bispectral index between 40-60, remifentanil infusion started at 0.1mcg/kg/min titrated to keep blood pressure within 20 % of baseline values, and rocuronium that will be administered at the discretion of the anesthesiologist. Upon termination of the surgery, neuromuscular blockade will be antagonized with a combination of neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. Subjects will also receive Ketorolac 30 mg IV after discontinuation of remifentanil for postoperative pain control. Ondansetron 4 mg IV will be administered to decrease postoperative nausea and vomiting. Subjects will receive IV hydromorphone 0.4 mg q 5 minutes as needed to achieve a verbal rating score for pain \<4 out of 10.They will also receive reglan 10 mg IV as a rescue antiemetic, if not effective, a second dose of Zofran 4 mg IV will be given in PACU. 24 hours after surgery a QOR 40 will be administered to the patient by one of the investigators. The primary and secondary outcomes will be assessed by an independent observer who will be blinded to group allocation.

Interventions

DRUGSevoflurane

Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube

DRUGPropofol

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

* Women * Age 18-64 * Patients undergoing ambulatory surgery * ASA PS I, II

Exclusion criteria

* Chronic opioid use * Pregnant patient Drop Out : patient or surgeon request

Design outcomes

Primary

MeasureTime frameDescription
Quality of Recovery Score 24 Hours Post Operative24 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.

Secondary

MeasureTime frameDescription
Mg of Morphine Equivalents (IV)PACU admission to dischargeTotal opioid use in the post operative care unit (Mg of morphine equivalents)
Pain in Post Anesthesia Care UnitTime 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.
Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.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.

Countries

United States

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
Sevoflurane
Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube) Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
45
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
45
Total90

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall Studycase cancelled10
Overall StudyChange in surgical case21
Overall StudyLost to Follow-up116
Overall Studyunblinded10
Overall StudyWithdrawal by Subject01

Baseline characteristics

CharacteristicSevofluranePropofolTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
45 Participants45 Participants90 Participants
Region of Enrollment
United States
45 participants45 participants90 participants
Sex: Female, Male
Female
45 Participants45 Participants90 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
13 / 3011 / 37
serious
Total, serious adverse events
0 / 300 / 37

Outcome results

Primary

Quality of Recovery Score 24 Hours Post Operative

Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.

Time frame: 24 hours after the surgical procedure

ArmMeasureValue (MEDIAN)
SevofluraneQuality of Recovery Score 24 Hours Post Operative175 units on a scale
PropofolQuality of Recovery Score 24 Hours Post Operative176 units on a scale
p-value: 0.97Wilcoxon (Mann-Whitney)
Secondary

Mg of Morphine Equivalents (IV)

Total opioid use in the post operative care unit (Mg of morphine equivalents)

Time frame: PACU admission to discharge

ArmMeasureValue (MEDIAN)
SevofluraneMg of Morphine Equivalents (IV)9 miligrams of morphine equivalents
PropofolMg of Morphine Equivalents (IV)9.4 miligrams of morphine equivalents
p-value: 0.96Wilcoxon (Mann-Whitney)
Secondary

Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.

Opioid use in mg of morphine equivalents from discharge from the post anesthesia care unit to 24 hours after PACU discharge.

Time frame: Discharge from PACU to 24 hours post operative after PACU discharge.

ArmMeasureValue (MEDIAN)
SevofluraneOpioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.30 mg morphine equivalents
PropofolOpioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge.25 mg morphine equivalents
p-value: 0.84Wilcoxon (Mann-Whitney)
Secondary

Pain in Post Anesthesia Care Unit

Numeric 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.

Time frame: Time in the post anesthesia care unit

ArmMeasureValue (MEDIAN)
SevofluranePain in Post Anesthesia Care Unit270 Pain Score * minutes in PACU
PropofolPain in Post Anesthesia Care Unit240 Pain Score * minutes in PACU
p-value: 0.96Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026