Propofol Versus Sevoflurane Recovery After Gynecological Surgery

• ClinicalTrials.gov Identifier: NCT01755234
• Recruitment Status: Completed
• First Posted: December 24, 2012
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Gildasio De Oliveira, Northwestern University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Surgery; Anesthesia	Drug: Sevoflurane; Drug: Propofol	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: The Effects of Propofol vs. Sevoflurane Administered During Anesthesia Maintenance on Early and Late Recovery After Gynecological Surgery
• Study Start Date: November 2012
• Actual Primary Completion Date: April 2014
• Actual Study Completion Date: April 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Sevoflurane; Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)	Drug: Sevoflurane; Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube; Other Name: Sevoflurane,Ultane
Active Comparator: 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	Drug: 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; Other Name: Propofol,Diprivan

Outcome Measures

Primary Outcome Measures :

1. Quality of Recovery Score 24 Hours Post Operative [ Time Frame: 24 hours after the surgical procedure ]
   Quality of recovery score 24 hours after the surgical procedure.Score of 40 is poor recovery and a score of 200 is good recovery.

Secondary Outcome Measures :

1. Mg of Morphine Equivalents (IV) [ Time Frame: PACU admission to discharge ]
   Total opioid use in the post operative care unit (Mg of morphine equivalents)
2. Pain in Post Anesthesia Care Unit [ Time Frame: Time in the 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.

3. Opioid Use Discharge From Post Anesthesia Care Unit to 24 Hours After PACU Discharge. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 64 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Illinois

Prentice Women's Hospital

Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

• Principal Investigator: Gildasio De Oliveira, MD; Northwestern University

More Information

Publications:

White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. Review.

White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-22. Review.

Zhang Y, Eger EI 2nd, Dutton RC, Sonner JM. Inhaled anesthetics have hyperalgesic effects at 0.1 minimum alveolar anesthetic concentration. Anesth Analg. 2000 Aug;91(2):462-6.

Hand R Jr, Riley GP, Nick ML, Shott S, Faut-Callahan M. The analgesic effects of subhypnotic doses of propofol in human volunteers with experimentally induced tourniquet pain. AANA J. 2001 Dec;69(6):466-70.

Cheng SS, Yeh J, Flood P. Anesthesia matters: patients anesthetized with propofol have less postoperative pain than those anesthetized with isoflurane. Anesth Analg. 2008 Jan;106(1):264-9, table of contents. doi: 10.1213/01.ane.0000287653.77372.d9.

Boccara G, Mann C, Pouzeratte Y, Bellavoir A, Rouvier A, Colson P. Improved postoperative analgesia with isoflurane than with propofol anaesthesia. Can J Anaesth. 1998 Sep;45(9):839-42.

Visser K, Hassink EA, Bonsel GJ, Moen J, Kalkman CJ. Randomized controlled trial of total intravenous anesthesia with propofol versus inhalation anesthesia with isoflurane-nitrous oxide: postoperative nausea with vomiting and economic analysis. Anesthesiology. 2001 Sep;95(3):616-26.

Watson KR, Shah MV. Clinical comparison of 'single agent' anaesthesia with sevoflurane versus target controlled infusion of propofol. Br J Anaesth. 2000 Oct;85(4):541-6.

Röhm KD, Piper SN, Suttner S, Schuler S, Boldt J. Early recovery, cognitive function and costs of a desflurane inhalational vs. a total intravenous anaesthesia regimen in long-term surgery. Acta Anaesthesiol Scand. 2006 Jan;50(1):14-8. Retraction in: Acta Anaesthesiol Scand. 2011 Aug;55(7):903.

Retraction in: Acta Anaesthesiol Scand. 2011 Aug;55(7):903

Montes FR, Trillos JE, Rincón IE, Giraldo JC, Rincón JD, Vanegas MV, Charris H. Comparison of total intravenous anesthesia and sevoflurane-fentanyl anesthesia for outpatient otorhinolaryngeal surgery. J Clin Anesth. 2002 Aug;14(5):324-8.

Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

De Oliveira GS Jr, Bialek J, Rodes ME, Kendall MC, McCarthy RJ. The effect of sevoflurane compared to propofol maintenance on post-surgical quality of recovery in patients undergoing an ambulatory gynecological surgery: A prospective, randomized, double-blinded, controlled, clinical trial. J Clin Anesth. 2017 Dec;43:70-74. doi: 10.1016/j.jclinane.2017.10.001. Epub 2017 Oct 13.

• Responsible Party: Gildasio De Oliveira, Prinipal Investigator, Northwestern University
• ClinicalTrials.gov Identifier: NCT01755234
• Other Study ID Numbers: STU00070833
• First Posted: December 24, 2012
• Results First Posted: March 14, 2016
• Last Update Posted: March 14, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Gildasio De Oliveira, Northwestern University:

Outpatient; Surgery; Anesthesia

Additional relevant MeSH terms:

Propofol; Sevoflurane; Hypnotics and Sedatives; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Platelet Aggregation Inhibitors; Anesthetics, Inhalation