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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Nasopharyngeal secretions under general anesthesia

Ocular surgery

Propofol-based total intravanous anesthesia (TIVA)

Condition category

Condition code

Anaesthesiology

Anaesthetics

Eye

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]

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]

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]

From the end of surgery to extubation of the endotracheal tube

Secondary outcome [1]

Incidence of PONV, assessed by review of medical records.

Timepoint [1]

1 day after surgery

Secondary outcome [2]

Proportion of participants with prolonged extubation (>15 minutes from end of surgery to extubation), assessed by review of medical records.

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Taiwan, Province Of China

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

None

Address [1]

None

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Ethics Committee of the Tri-Service General Hospital

Ethics committee address [1]

#325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.

Ethics committee country [1]

Taiwan, Province Of China

Date submitted for ethics approval [1]

01/10/2015

Approval date [1]

13/10/2015

Ethics approval number [1]

TSGHIRB No: 2-104-05-129

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.

Trial website

Trial related presentations / publications

None

Public notes

Contacts

Principal investigator

Name

Dr Hou-Chuan Lai

Address

Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.

Country

Taiwan, Province Of China

Phone

+886-2-87927128

Fax

m99ane@gmail.com

Contact person for public queries

Name

Zhi-Fu Wu

Address

Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.

Country

Taiwan, Province Of China

Phone

+886-2-87927128

Fax

aneswu@gmail.com

Contact person for scientific queries

Name

Zhi-Fu Wu

Address

Tri-Service General Hospital and National Defense Medical Center, #325, Section 2, Chenggung Road, Neihu 114, Taipei, Taiwan, Republic of China.

Country

Taiwan, Province Of China

Phone

+886-2-87927128

Fax

aneswu@gmail.com

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

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Documents added automatically

No additional documents have been identified.

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