NCT01437462

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 10, 2013

Status Verified

April 1, 2013

Enrollment Period

4.4 years

First QC Date

September 19, 2011

Last Update Submit

April 9, 2013

Conditions

Healthy AdultsGynecological Disease

Keywords

Pain, PostoperativeAnesthetics, intravenousAnesthetics, inhalationOtherwise healthy adults undergoing general anesthesia for gynecological disease.

Outcome Measures

Primary Outcomes (1)

  • 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.

    20 hours

Secondary Outcomes (1)

  • NRS (numeral rating scale) of pain

    20 hours

Interventions

SevofluraneDRUG

Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery

Also known as: Baxter Sevofluran
PropofolDRUG

Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery

Also known as: Propofol Lipuro

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Body Mass Index over 35
  • Diabetes mellitus
  • Liver disease
  • Allergies to pharmaceuticals used in the Study
  • Present use of opioids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Genital Diseases, FemalePain, PostoperativeRespiratory Aspiration

Interventions

SevofluranePropofol

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Methyl EthersEthersOrganic ChemicalsHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2011

First Posted

September 21, 2011

Study Start

October 1, 2008

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 10, 2013

Record last verified: 2013-04

Locations

FI(1)