Sevoflurane, Propofol, Postoperative Pain
This study has been completed.
Sponsor:
Tampere University Hospital
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
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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:
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:
-
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
Eligibility| Ages Eligible for Study: | 18 Years to 69 Years |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01437462
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
No publications provided
| 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:
|
Genital Diseases, Female Propofol Sevoflurane Anesthetics Anesthetics, General Anesthetics, Inhalation Anesthetics, Intravenous Central Nervous System Agents |
Central Nervous System Depressants Hematologic Agents Hypnotics and Sedatives Pharmacologic Actions Physiological Effects of Drugs Platelet Aggregation Inhibitors Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015