Sevoflurane, Propofol, Postoperative Pain

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Arvi Yli-Hankala, Tampere University Hospital

ClinicalTrials.gov Identifier:

NCT01437462

First received: September 19, 2011

Last updated: April 9, 2013

Last verified: April 2013

History of Changes

Purpose

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	Intervention	Phase
Healthy Adults Gynecological Disease	Drug: Sevoflurane Drug: Propofol	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial

Resource links provided by NLM:

Drug Information available for: Propofol Sevoflurane

U.S. FDA Resources

Further study details as provided by Tampere University Hospital:

Primary Outcome Measures:

Postoperative consumption of an opioid (oxycodone) [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
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 [ Time Frame: 20 hours ] [ Designated as safety issue: No ]
NRS is evaluated frequently during the study period.


Enrollment:	168
Study Start Date:	October 2008
Study Completion Date:	March 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Intervention Details:

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

Other Name: Baxter Sevofluran

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

Other Name: Propofol Lipuro

Eligibility


Ages Eligible for Study:	18 Years to 69 Years (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01437462

Locations


Finland
Tampere University Hospital
Tampere, Finland, 33521

Sponsors and Collaborators

Tampere University Hospital

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
Study First Received:	September 19, 2011
Last Updated:	April 9, 2013
Health Authority:	Finland: Finnish Medicines Agency

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016

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