Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000381785
Ethics application status
Approved
Date submitted
25/03/2013
Date registered
9/04/2013
Date last updated
9/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bispectral index-guided general anaesthesia in combination with interscalene block reduces desflurane consumption in arthroscopic shoulder surgery: a clinical comparison of bupivacaine versus levobupivacaine
Scientific title
General anaesthesia in combination with interscalene block reduces desflurane consumption in arthroscopic shoulder surgery: a clinical comparison of bupivacaine versus levobupivacaine
Secondary ID [1] 282172 0
none
Universal Trial Number (UTN)
none
Trial acronym
Interscalene block plus general anaesthesia and Desflurane consumption
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients who had rotator cuff tears or shoulder instability or calcific tendonitis tendinitis were included in this prospective, randomized, double-blind clinical trial. 288683 0
Condition category
Condition code
Anaesthesiology 289030 289030 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients were allocated into one of three groups in a double-blind manner. Group B (n=20) received a single-shot interscalene brachial plexus block with bupivacaine 0.25% (Marcaine, Astra Zeneca, Sweden) 40 ml before induction. Group L (n=20) received a single-shot ISB with levobupivacaine 0.25% (Chirocaine, Abbott Laboratories, North Chicago, USA) 40 ml before induction in combination with GA.Skin puncture was performed, and the needle was advanced until a contraction of the deltoid or biceps muscle appeared.After evidence of a successful sensory and motor block was obtained, the patients received a standardized anesthetic protocol.Following administration of 100% oxygen, anaesthesia was induced with IV thiopental 5-7 mg/ml and IV fentanyl 2 µg/kg.Then the patients received IV rocuronium 0.6 mg/kg, and the trachea was intubated so that the lungs were mechanically ventilated with a tidal volume of 8-10 ml/kg, with the ventilatory rate adjusted to maintain an end-tidal carbon dioxide concentration (partial pressure) of 30-35 mm Hg. Anaesthesia was continued with delivered (FD) desflurane 6% (FD desflurane Suprane®, Baxter, Puerto Rico, USA) in 60% nitrous oxide with oxygen, and the fresh gas flow was standardized. The desflurane concentration was then titrated to keep the BIS score in the 40-60 range. If the BIS value was less than 40 for more than 30 seconds, the FD desflurane was decreased by 25%. Follow up period is during the surgery and postoperatively 24 hours
Intervention code [1] 286780 0
Treatment: Surgery
Intervention code [2] 286781 0
Not applicable
Comparator / control treatment
Group C (n=20 - control group) received GA alone. Follow up period is during the surgery and postoperatively 24 hours
Control group
Active

Outcomes
Primary outcome [1] 289145 0
The goal of this study was to compare the influence of an interscalene brachial plexus block (ISB) performed with either bupivacaine or levobupivacaine in conjunction with general anaesthesia (GA) on desflurane consumption.The desflurane was administered by a Sigma Alpha vaporizer (Penlon Limited, UK), and the amount used was measured in milliliters after completion of each surgical procedure by refilling the vaporizer, which initially had been completely full.
Timepoint [1] 289145 0
The first time point is the eye opening time after surgery.
It will be assessed at post anesthetic care unit.
Secondary outcome [1] 301924 0
The secondary outcome isanalgesic requirements after surgery .Patient satisfaction (0 = not satisfied, 1 = moderate, 2 = good, 3 = very good) and postoperative pain scores [using a 10 cm Visual Analog Scale (VAS) in which 0 cm = no pain and 10 cm = the worst pain imaginable] were evaluated on arrival at the PACU and at two, four, six, eight, and 24 hours after surgery.
Timepoint [1] 301924 0
the first day after surgery

Eligibility
Key inclusion criteria
who underwent elective arthroscopic shoulder surgery by the same surgeon were included in this prospective, randomized, double-blind clinical trial.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
who had general contraindications for ISB, obstructive pulmonary disease, diabetes, neuropathy, contralateral diaphragmatic paralysis, a history of allergic reaction to any of the study drugs, ongoing hypnotic therapy, or any documented preoperative systemic disease that could interfere with general anaesthesia were excluded from the study

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary end point of this study was defined as a reduction in desflurane consumption. Sample size estimation was performed by using MINITAB 15 software. Sample size was predetermined by using a power analysis: a=0.05 and ß=0.2, and this showed that 19 patients per group would be sufficient.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/12/2010
Actual
10/02/2011
Date of last participant enrolment
Anticipated
30/12/2011
Actual
28/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 4951 0
Turkey
State/province [1] 4951 0

Funding & Sponsors
Funding source category [1] 286943 0
Self funded/Unfunded
Name [1] 286943 0
Levent Ozturk
Country [1] 286943 0
Turkey
Primary sponsor type
Individual
Name
Levent Ozturk
Address
Ankara Ataturk Training and Research Hospital, Anesthesiology and Reanimation Department. Bilkent No: 2, Ankara. 06800
Country
Turkey
Secondary sponsor category [1] 285728 0
Individual
Name [1] 285728 0
Elvin Kesimci
Address [1] 285728 0
Ankara Ataturk Training and Research Hospital, Anesthesiology and Reanimation Department. Bilkent No: 2, Ankara. 06800
Country [1] 285728 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288995 0
Ethics Committee Number 5/Ankara
Ethics committee address [1] 288995 0
Ethics committee country [1] 288995 0
Turkey
Date submitted for ethics approval [1] 288995 0
15/12/2009
Approval date [1] 288995 0
23/02/2010
Ethics approval number [1] 288995 0
2229

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38698 0
Dr Levent Ozturk
Address 38698 0
Ankara Ataturk Training and Research Hospital. Bilkent No: 2, Ankara. 06800
Country 38698 0
Turkey
Phone 38698 0
+903122912706
Fax 38698 0
Email 38698 0
[email protected]
Contact person for public queries
Name 38699 0
Elvin Kesimci
Address 38699 0
Ankara Ataturk Training and Research Hospital. Bilkent No: 2, Ankara. 06800
Country 38699 0
Turkey
Phone 38699 0
+903122912525/3006
Fax 38699 0
Email 38699 0
[email protected]
Contact person for scientific queries
Name 38700 0
Elvin Kesimci
Address 38700 0
Ankara Ataturk Training and Research Hospital. Bilkent No: 2, Ankara. 06800
Country 38700 0
Turkey
Phone 38700 0
+903122912525/3006
Fax 38700 0
Email 38700 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIBispectral index-guided general anaesthesia in combination with interscalene block reduces desflurane consumption in arthroscopic shoulder surgery: a clinical comparison of bupivacaine versus levobupivacaine2015https://doi.org/10.1186/s12871-015-0087-8
N.B. These documents automatically identified may not have been verified by the study sponsor.