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Sevoflurane, Propofol, Postoperative Pain

Primary Purpose

Healthy Adults, Gynecological Disease

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Sevoflurane
Propofol
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy Adults focused on measuring Pain, Postoperative, Anesthetics, intravenous, Anesthetics, inhalation, Otherwise healthy adults undergoing general anesthesia for gynecological disease.

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital

Outcomes

Primary Outcome Measures

Postoperative consumption of an opioid (oxycodone)
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

NRS (numeral rating scale) of pain
NRS is evaluated frequently during the study period.

Full Information

First Posted
September 19, 2011
Last Updated
April 9, 2013
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01437462
Brief Title
Sevoflurane, Propofol, Postoperative Pain
Official Title
Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tampere University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Adults, Gynecological Disease
Keywords
Pain, Postoperative, Anesthetics, intravenous, Anesthetics, inhalation, Otherwise healthy adults undergoing general anesthesia for gynecological disease.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Other Intervention Name(s)
Baxter Sevofluran
Intervention Description
Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery
Intervention Type
Drug
Intervention Name(s)
Propofol
Other Intervention Name(s)
Propofol Lipuro
Intervention Description
Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery
Primary Outcome Measure Information:
Title
Postoperative consumption of an opioid (oxycodone)
Description
The consumption of oxycodone will be monitored by recording the amount of the drug received via a commercially available patient controlled analgesia (PCA) pump.
Time Frame
20 hours
Secondary Outcome Measure Information:
Title
NRS (numeral rating scale) of pain
Description
NRS is evaluated frequently during the study period.
Time Frame
20 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

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Sevoflurane, Propofol, Postoperative Pain

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