Propofol Versus Sevoflurane Recovery After Gynecological Surgery
| Status: | Completed |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 4/21/2016 |
| Start Date: | November 2012 |
| End Date: | April 2014 |
The Effects of Propofol vs. Sevoflurane Administered During Anesthesia Maintenance on Early and Late Recovery After Gynecological Surgery
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.
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.
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.
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.
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
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