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Trial registered on ANZCTR
Registration number
ACTRN12616001120460
Ethics application status
Approved
Date submitted
4/07/2016
Date registered
17/08/2016
Date last updated
17/08/2016
Type of registration
Retrospectively registered
Titles & IDs
Public title
Combination with Sevoflurane Anesthesia Attenuates Nasopharyngeal Secretions in Propofol-Based Total Intravenous Anesthesia in Ocular Surgery
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Scientific title
Combination with Sevoflurane Anesthesia Attenuates Nasopharyngeal Secretions in Propofol-Based Total Intravenous Anesthesia in Ocular Surgery
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Secondary ID [1]
289606
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal secretions under general anesthesia
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Ocular surgery
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Propofol-based total intravanous anesthesia (TIVA)
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Condition category
Condition code
Anaesthesiology
299377
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0
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Anaesthetics
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Eye
299428
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0
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Diseases / disorders of the eye
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In the propofol/sevoflurane group, the anesthesia induction were as the total intravenous anaesthesia (TIVA) group patients, whereas anesthesia was maintained using intravenous propofol infusion and 1% sevoflurane (inhaled concentration) with with 50% oxygen flow of 1 mL/min by the treating anaesthetist.
Maintenance of the effect-site concentration (Ce) for the propofol/sevoflurane was adjusted to keep BIS value between 40–60 and mean arterial blood pressure at 80–100 mm Hg determined by the treating anaesthetist. The EtCO2 pressure was maintained at 35-45 mmHg. Once neuromuscular function returns, rocuronium (0.1 mg/kg, intravenously [i.v.]) was administered as required by the treating anaesthetist. All patients received i.v. methasone 0.1 mg/kg for preventing post-operative nausea and vomiting (PONV) while induction of anaesthesia by the treating anaesthetist..
At the end of the procedure, propofol or sevoflurane was discontinued and the lungs were ventilated with 100% oxygen at a fresh gas flow of 6 L/min by the treating anaesthetist. Reversal of neuromuscular function was achieved by administrating neostigmine (0.03-0.04 mg/kg, i.v.) with glycopyrrolate (0.006-0.008 mg/kg, i.v.) once spontaneous breathing returned to prevent residual paralysis at the clinical discretion of the treating anaesthetist. When the patient regained consciousness by name with spontaneous and smooth respiration, the endotracheal tube was removed and the patient was sent to the postoperative anesthesis care unit for further care.
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Intervention code [1]
295215
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Treatment: Drugs
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Comparator / control treatment
In the propofol-based TIVA group, anesthesia was induced using intravenous (i.v.) fentanyl (2 microg/kg) and 2% lidocaine (1.5 mg/kg, i.v.) by the treating anaesthetist. Continuous intravenous infusion of propofol was delivered subsequently using Schneider’s kinetic model of target-controlled infusion (TCI; Fresenius Orchestra Primea; Fresenius Kabi AG, Bad Homburg, Germany) with the effect-site concentration (Ce) of 4.0 microg/mL by the treating anaesthetist. Rocuronium (0.6 mg/ kg, i.v.) was given when patients lost consciousness, followed by tracheal intubation by the treating anaesthetist. GA was maintained with TCI propofol infusion and 1.0 L/min flow with 50% oxygen by the treating anaesthetist..
Maintenance of the Ce for the TIVA was adjusted to keep BIS value between 40–60 and mean arterial blood pressure at 80–100 mm Hg by the treating anaesthetist. The EtCO2 pressure was maintained at 35-45 mmHg. Once neuromuscular function returns, rocuronium (0.1 mg/kg, i.v.) was administered as required. All patients received i.v. methasone 0.1 mg/kg for preventing PONV while induction of anaesthesia by the treating anaesthetist.
At the end of the procedure, propofol was discontinued and the lungs were ventilated with 100% oxygen at a fresh gas flow of 6 L/min by the treating anaesthetist. Reversal of neuromuscular function was achieved by administrating neostigmine (0.03-0.04 mg/kg, i.v.) with glycopyrrolate (0.006-0.008 mg/kg, i.v.) once spontaneous breathing returned to prevent residual paralysis at the clinical discretion of the treating anaesthetist. When the patient regained consciousness by name with spontaneous and smooth respiration, the endotracheal tube was removed and the patient was sent to the postoperative anesthesis care unit for further care.
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Control group
Active
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Outcomes
Primary outcome [1]
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Total volume of nasopharyngeal secretions was determined by collecting them with frequent suction via nasal and oral cavities by using the suction apparatus from the end of surgery to extubation of the endotracheal tube by the anaesthesiologist,
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Assessment method [1]
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Timepoint [1]
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From the end of surgery to extubation of the endotracheal tube
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Secondary outcome [1]
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Incidence of PONV, assessed by review of medical records.
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Assessment method [1]
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Timepoint [1]
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1 day after surgery
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Secondary outcome [2]
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Proportion of participants with prolonged extubation (>15 minutes from end of surgery to extubation), assessed by review of medical records.
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Assessment method [2]
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Timepoint [2]
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At time of extubation.
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Eligibility
Key inclusion criteria
50 patients scheduled to undergo ocular surgery by one ophthalmologist under GA were enrolled in this study
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Minimum age
20
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
(1) age < 20 years or older than 80 years, (2) American Society of Anesthesiologists (ASA) physical status of more than III, (3) body mass index (BMI) > 30 kg/m2, (4) possible pregnancy, (5) emergent surgeries, (6) uremia, and (7) liver disease.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Based on a 10 patients' preliminary data from our institution in the same surgical population, a power analysis was performed by reducing nasopharyngeal secretions as the primary variable. We calculated a sample size so that a reducing 15 ml (50%) of nasopharyngeal secretions would permit a one-tailed type I error rate of a = 0.05 with a power of 80%. This analysis indicated that a sample size of at least 23 patients per group was necessary. To allow for potential dropouts, we enrolled a total of 25 patients in each group. Data are presented as the mean and standard deviation (SD) or number of patients. Demographic and perioperative variables were compared using Student’s t-tests or Mann–Whitney test while the data were not normally distributed. Categorical variables were compared using chi-square test. Statistical significance was accepted for two-tailed P values of < 0.05. The statistics was performed by using SigmaStat 3.5 for Windows.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
29/10/2015
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Date of last participant enrolment
Anticipated
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Actual
15/03/2016
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Date of last data collection
Anticipated
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Actual
15/03/2016
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Sample size
Target
50
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Accrual to date
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Final
50
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Recruitment outside Australia
Country [1]
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Taiwan, Province Of China
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State/province [1]
8006
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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None
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Address [1]
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None
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Country [1]
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Primary sponsor type
Hospital
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Name
Tri-Service General Hospital
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Address
#325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
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Country
Taiwan, Province Of China
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Secondary sponsor category [1]
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None
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Name [1]
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None
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Address [1]
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None
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Ethics Committee of the Tri-Service General Hospital
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Ethics committee address [1]
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#325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
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Ethics committee country [1]
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Taiwan, Province Of China
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Date submitted for ethics approval [1]
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01/10/2015
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Approval date [1]
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13/10/2015
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Ethics approval number [1]
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TSGHIRB No: 2-104-05-129
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Summary
Brief summary
Background: About 10% patients under general anesthesia had nasopharyngeal secretions on the face at the end of ocular surgery, and secretions toward the eye in some patients. It may induce postoperative endophthalmitis, although rare, still of great concern to the ophthalmologist. Therefore, anesthetics that produce less nasopharyngeal secretions are desirable. Nasopharyngeal excretion under propofol-based total intravanous anesthesia (TIVA) is greater than sevoflurane anesthesia during surgery. However, postoperative nausea and vomiting (PONV) after inhalational anesthesia is higher than TIVA and may increase intraocluar pressure. As our best knlowldge, no previous report discussed the nasopharyngeal secretions and PONV while sevoflurane combines with propofol anesthesia. Therefore, the aim of this study is to investigate the effect of sevoflurane combination with propofol-based TIVA on nasopharyngeal secrtions and PONV in ocular surgery.
Methods: Fifty patients undergoing ocular surgery were randomly assigned for propofol-based TIVA or propofol/sevoflurane anesthesia. In the TIVA group patients (n = 25), anesthesia was induced and maintained with propofol and i.v. fentanyl, whereas, in the propofol/sevoflurane group patients (n = 25), 1% sevoflurane anesthesia was added. All patient were moniotored under bispectral index (BIS). We prospectively compared the nasopharyngeal secretion volume, extubation time and incidence of PONV after the procedure in both groups.
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Trial website
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Trial related presentations / publications
None
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Public notes
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Contacts
Principal investigator
Name
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Dr Hou-Chuan Lai
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Address
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Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
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Country
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Taiwan, Province Of China
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Phone
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+886-2-87927128
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Zhi-Fu Wu
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Address
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Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
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Country
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Taiwan, Province Of China
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Phone
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+886-2-87927128
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Zhi-Fu Wu
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Address
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Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
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Country
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Taiwan, Province Of China
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Phone
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+886-2-87927128
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Fax
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Email
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[email protected]
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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
No additional documents have been identified.
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