Sevoflurane, Propofol, Postoperative Pain

Healthy Adults Clinical Trial

Official title:

Postoperative Pain After Propofol Sevoflurane Anaesthesia: a Prospective, Randomized, Single-blinded Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01437462
• Other study ID #: Satu_Pokkinen_01_2011
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2011
• Last updated: April 9, 2013
• Start date: October 2008
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 69 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecological Disease
• Healthy Adults
• Pain, Postoperative

Intervention

Drug:
• Sevoflurane
Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery
• Propofol
Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	NRS (numeral rating scale) of pain	NRS is evaluated frequently during the study period.	20 hours	No