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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN25537214 |
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Date of registration:
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11/11/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Sevoflurane-remifentanyl versus propofol-remifentanyl in surgery exceeding 4 hours
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Scientific title:
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Date of first enrolment:
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12/06/2002 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN25537214 |
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Study type:
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Interventional |
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Study design:
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Randomised active controlled parallel group trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Basil
Matta |
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Address:
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Addenbrooke's Hospital
CB2 2QQ
Cambridge
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients undergoing surgery over 4 hours.
Exclusion criteria: 1. Allergy to sevoflurane or remifentanyl
2. Patient refusal
3. Morbidly obese
4. American Society of Anesthesiologists (ASA) 3 or higher
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Prolonged surgery
Surgery
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Intervention(s)
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Please note that as of 04/08/10 the status of this trial has been updated to "Stopped". The study was closed on 16/01/09 due to difficulties in patient recruitment. The study did not reach sufficient power for trialists to reach a conclusion based on statistical significance.
The main findings were that in the limited number of subjects? studied, there no significant differences between the groups in either the primary or secondary objectives. However, it was evident that both techniques can be used effectively for these types of operations.
Randomised into receiving one of two types of anaesthesia.
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Primary Outcome(s)
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Haemodynamic stability
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Secondary Outcome(s)
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1. Nausea
2. Vomiting
3. Wake up time
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Source(s) of Monetary Support
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Abbott Laboratories (UK) - Unrestricted educational grant
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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