Propofol Versus Sevoflurane Recovery After Gynecological Surgery

NCT01755234 | Completed Phase 4 Results

• 1 other identifier: STU00070833
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Anesthesia

Keywords

Outpatient; Surgery; Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours after the surgical procedure

Secondary Outcomes (3)

• Mg of Morphine Equivalents (IV)

  PACU admission to discharge

• Pain in Post Anesthesia Care Unit

  Time in the post anesthesia care unit

• 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.

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)

Drug: Sevoflurane

Propofol

ACTIVE COMPARATOR

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

Interventions

Sevoflurane DRUG

Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube

Also known as: Sevoflurane,Ultane

Sevoflurane

Propofol DRUG

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

Also known as: Propofol,Diprivan

Propofol

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

• 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. No abstract available.

  PMID: 20010418 BACKGROUND

• White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-S22. doi: 10.1213/01.ANE.0000177099.28914.A7.

  PMID: 16334489 BACKGROUND

• 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. doi: 10.1097/00000539-200008000-00044.

  PMID: 10910869 BACKGROUND

• 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.

  PMID: 11837149 BACKGROUND

• 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.

  PMID: 18165589 BACKGROUND

• 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. doi: 10.1007/BF03012216.

  PMID: 9818105 BACKGROUND

• 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. doi: 10.1097/00000542-200109000-00012.

  PMID: 11575532 BACKGROUND

• 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. doi: 10.1093/bja/85.4.541.

  PMID: 11064611 BACKGROUND

• Rohm 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. doi: 10.1111/j.1399-6576.2006.00905.x.

  PMID: 16451145 BACKGROUND

• Montes FR, Trillos JE, Rincon IE, Giraldo JC, Rincon 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. doi: 10.1016/s0952-8180(02)00367-7.

  PMID: 12208434 BACKGROUND

• 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. doi: 10.1093/oxfordjournals.bja.a013366.

  PMID: 10740540 BACKGROUND

• 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.

  PMID: 29032007 DERIVED

MeSH Terms

Interventions

Sevoflurane; Propofol

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Limitations and Caveats

We only studied patients undergoing outpatient laparoscopic gynecological surgery, therefore, our results cannot be generalizable to other surgical procedures. We also administered remifentanil which is has been linked to hyperalgesia.

Results Point of Contact

• Title: Gildasio De Oliveira
• Organization: Northwestern University

g-jr@northwestern.edu

312-695-4858

Study Officials

• Gildasio De Oliveira, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinipal Investigator

Study Record Dates

• First Submitted: December 18, 2012
• First Posted: December 24, 2012
• Study Start: November 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 14, 2016
• Results First Posted: March 14, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)