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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
Scientific title
Combination with Sevoflurane Anesthesia Attenuates Nasopharyngeal Secretions in Propofol-Based Total Intravenous Anesthesia in Ocular Surgery
Secondary ID [1] 289606 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nasopharyngeal secretions under general anesthesia 299389 0
Ocular surgery 299390 0
Propofol-based total intravanous anesthesia (TIVA) 299391 0
Condition category
Condition code
Anaesthesiology 299377 299377 0 0
Anaesthetics
Eye 299428 299428 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 295215 0
Treatment: Drugs
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.
Control group
Active

Outcomes
Primary outcome [1] 298835 0
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,
Timepoint [1] 298835 0
From the end of surgery to extubation of the endotracheal tube
Secondary outcome [1] 325374 0
Incidence of PONV, assessed by review of medical records.
Timepoint [1] 325374 0
1 day after surgery
Secondary outcome [2] 325562 0
Proportion of participants with prolonged extubation (>15 minutes from end of surgery to extubation), assessed by review of medical records.
Timepoint [2] 325562 0
At time of extubation.

Eligibility
Key inclusion criteria
50 patients scheduled to undergo ocular surgery by one ophthalmologist under GA were enrolled in this study
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
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 receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
29/10/2015
Date of last participant enrolment
Anticipated
Actual
15/03/2016
Date of last data collection
Anticipated
Actual
15/03/2016
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 8006 0
Taiwan, Province Of China
State/province [1] 8006 0

Funding & Sponsors
Funding source category [1] 293989 0
Self funded/Unfunded
Name [1] 293989 0
None
Country [1] 293989 0
Primary sponsor type
Hospital
Name
Tri-Service General Hospital
Address
#325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
Country
Taiwan, Province Of China
Secondary sponsor category [1] 292806 0
None
Name [1] 292806 0
None
Address [1] 292806 0
None
Country [1] 292806 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295405 0
The Ethics Committee of the Tri-Service General Hospital
Ethics committee address [1] 295405 0
Ethics committee country [1] 295405 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 295405 0
01/10/2015
Approval date [1] 295405 0
13/10/2015
Ethics approval number [1] 295405 0
TSGHIRB No: 2-104-05-129

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

Contacts
Principal investigator
Name 67182 0
Dr Hou-Chuan Lai
Address 67182 0
Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
Country 67182 0
Taiwan, Province Of China
Phone 67182 0
+886-2-87927128
Fax 67182 0
Email 67182 0
[email protected]
Contact person for public queries
Name 67183 0
Zhi-Fu Wu
Address 67183 0
Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
Country 67183 0
Taiwan, Province Of China
Phone 67183 0
+886-2-87927128
Fax 67183 0
Email 67183 0
[email protected]
Contact person for scientific queries
Name 67184 0
Zhi-Fu Wu
Address 67184 0
Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.
Country 67184 0
Taiwan, Province Of China
Phone 67184 0
+886-2-87927128
Fax 67184 0
Email 67184 0
[email protected]

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