"Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail
This study has been completed.
Sponsor:
University Medical Centre Groningen
Information provided by (Responsible Party):
MMRF Struys, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01248871
First received: November 24, 2010
Last updated: December 18, 2012
Last verified: December 2012
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Purpose
To compare the renal protective properties of two currently used anaesthetic techniques - a sevoflurane-remifentanil/sufentanil combination with a propofol-remifentanil/sufentanil combination for anaesthesia in patients undergoing living donor kidney donation/transplantation.
| Condition | Intervention |
|---|---|
|
Kidney Donation/Transplantation |
Drug: procedure:sevoflurane-remifentanil/sufentanil Drug: volatile agent only during reperfusion Drug: propofol-remifentanil/sufentanil |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | "Volatile Anesthetic Protection Of Renal Transplants: VAPOR-1-trail |
Resource links provided by NLM:
Further study details as provided by University Medical Centre Groningen:
Primary Outcome Measures:
- To compare the renal protective properties of two currently used anaesthetic techniques [ Time Frame: participants will be followed for the duration of hospital stay ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | September 2010 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: SEVO
sevoflurane-remifentanil/sufentanil combination
|
Drug: procedure:sevoflurane-remifentanil/sufentanil
Active Comparator
|
|
Active Comparator: SERE
volatile agent only during reperfusion
|
Drug: volatile agent only during reperfusion
Active Comparator
|
|
Active Comparator: propofol
propofol-remifentanil/sufentanil
|
Drug: propofol-remifentanil/sufentanil
Active Comparator
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- All patients: Age > 18 years
Exclusion Criteria:
- patient refusal
- BMI< 17, >35
- neurological disorder
- recent use of psycho-active medication, including alcohol.
- Donor-recipient couples from the ABO-incompatible program
- Altruistic donor
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.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248871
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248871
Locations
| Netherlands | |
| University Medical Center Groningen | |
| Groningen, Netherlands, 9713 EZ | |
Sponsors and Collaborators
University Medical Centre Groningen
Investigators
| Principal Investigator: | M.M.R.F Struys, Prof.dr. | University Medical Centre Groningen | |
| Principal Investigator: | R,J. Ploeg, Prof.dr | University Medical Centre Groningen |
More Information
No publications provided
| Responsible Party: | MMRF Struys, Prof.dr., University Medical Centre Groningen |
| ClinicalTrials.gov Identifier: | NCT01248871 History of Changes |
| Other Study ID Numbers: | VAPOR 001 |
| Study First Received: | November 24, 2010 |
| Last Updated: | December 18, 2012 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
Keywords provided by University Medical Centre Groningen:
|
renal transplantation Volatile anesthetic |
Additional relevant MeSH terms:
|
Anesthetics Remifentanil Sufentanil Adjuvants, Anesthesia Analgesics Analgesics, Opioid Anesthetics, General Anesthetics, Intravenous Central Nervous System Agents |
Central Nervous System Depressants Hypnotics and Sedatives Narcotics Peripheral Nervous System Agents Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015