Propofol Versus Sevoflurane Recovery After Gynecological Surgery
Condition: Surgery; Anesthesia
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube; 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
Other intervention name(s): Sevoflurane,Ultane; Propofol,Diprivan
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Outpatient; Surgery; Anesthesia