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Sevoflurane, Propofol, Postoperative Pain

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ClinicalTrials.gov Identifier: NCT01437462
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : April 10, 2013
Sponsor:
Information provided by (Responsible Party):
Arvi Yli-Hankala, Tampere University Hospital

Study Description
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Brief Summary:
The impact of anaesthetic method (intravenous vs. inhalational) has been proposed, but not proven in a large-scale study. The researchers aim to provide an investigation that has sufficient power to clarify the potential effect of anaesthetic method on postoperative need of opioids. Sevoflurane and propofol will be compared.

Condition or disease Intervention/treatment Phase
Healthy Adults Gynecological Disease Drug: Sevoflurane Drug: Propofol Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial
Study Start Date : October 2008
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Drug: Sevoflurane
    Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery
    Other Name: Baxter Sevofluran
    Drug: Propofol
    Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery
    Other Name: Propofol Lipuro

Outcome Measures
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Primary Outcome Measures :
  1. Postoperative consumption of an opioid (oxycodone) [ Time Frame: 20 hours ]
    The consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump.


Secondary Outcome Measures :
  1. NRS (numeral rating scale) of pain [ Time Frame: 20 hours ]
    NRS is evaluated frequently during the study period.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-69 years
  • Gender: female
  • ASA status 1-3
  • Laparoscopic hysterectomy

Exclusion Criteria:

  • Body Mass Index over 35
  • Diabetes mellitus
  • Liver disease
  • Allergies to pharmaceuticals used in the Study
  • Present use of opioids
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01437462


Locations
Finland
Tampere University Hospital
Tampere, Finland, 33521
Sponsors and Collaborators
Tampere University Hospital
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Arvi Yli-Hankala, Professor, Tampere University Hospital
ClinicalTrials.gov Identifier: NCT01437462     History of Changes
Other Study ID Numbers: Satu_Pokkinen_01_2011
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: April 10, 2013
Last Verified: April 2013

Keywords provided by Arvi Yli-Hankala, Tampere University Hospital:
Pain, Postoperative
Anesthetics, intravenous
Anesthetics, inhalation
Otherwise healthy adults undergoing general anesthesia for gynecological disease.

Additional relevant MeSH terms:
Pain, Postoperative
Genital Diseases, Female
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
 Propofol
Sevoflurane
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Platelet Aggregation Inhibitors
Anesthetics, Inhalation