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Vitreous DetachmentNCT04865991

Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane

A study testing TCI Propofol and Sevoflurane in people with Vitreous Detachment, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was an experimental, single-blinded, randomized controlled trial that aimed to compare recovery time between TCI propofol and sevoflurane. After ethical approval from Research Ethical Committee Faculty of Medicine, Universitas Indonesia (879/UN2.F1/ETIK/2017) and informed consent, patients aged 18-65 years… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Vitreous Detachment
What is being tested?
TCI Propofol and Sevoflurane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteIndonesia
Study dates
1 Sep 2017to 31 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patients aged 18-65 years old
  • body mass index 18 - 30 kg/m2
  • American Society of Anesthesiologists (ASA) status I-II
  • scheduled for vitrectomy surgery under general anesthesia

Who cannot join

  • Patients with hemodynamic instability, allergy, raised intracranial pressure, and a history of hyperthermia malignant

Trial locations and contacts

1 site in 1 country.

Indonesia1 site
  • Cipto Mangunkusumo Cental National Hospital

    Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

Official title: Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane Recovery Time in Vitrectomy Surgery: a Randomized Controlled Trial

This study was an experimental, single-blinded, randomized controlled trial that aimed to compare recovery time between TCI propofol and sevoflurane. After ethical approval from Research Ethical Committee Faculty of Medicine, Universitas Indonesia (879/UN2.F1/ETIK/2017) and informed consent, patients aged 18-65 years old, body mass index 18 - 30 kg/m2, American Society of Anesthesiologists (ASA) status I-II who were scheduled for vitrectomy surgery under general anesthesia, at Kirana's Eye Operating Theatre Cipto Mangunkusumo National Referral Hospital from September until December 2017, were recruited in this study. All subjects would be recruited with a consecutive sampling method and randomly assigned into two groups, the TCI propofol group and sevoflurane group. Block random allocation was done for all subjects by using the random allocator program Winpepi.

Read the detailed description

This study was an experimental, single-blinded, randomized controlled trial that aimed to compare recovery time between TCI propofol and sevoflurane. After ethical approval from Research Ethical Committee Faculty of Medicine, Universitas Indonesia (879/UN2.F1/ETIK/2017) and informed consent, patients aged 18-65 years old, body mass index 18 - 30 kg/m2, American Society of Anesthesiologists (ASA) status I-II who were scheduled for vitrectomy surgery under general anesthesia, at Kirana's Eye Operating Theatre Cipto Mangunkusumo National Referral Hospital from September until December 2017, were recruited in this study. Patients with hemodynamic instability, allergy, raised intracranial pressure, and a history of hyperthermia malignant, were excluded from this study. Patients who have hearing disturbance, history of alcohol, opioid, or psychotropic drugs consumption before surgery, suffered from neuropsychiatric disease, and electrolyte imbalance was also excluded from this study. Patients who experience intraoperative cardiorespiratory disturbance, surgery duration less than 35 minutes or more than 3 hours and 30 minutes, and patients with temperature abnormalities before being extubated from LMA would be excluded from the trial.

Sample size The sample size calculation was performed with the unpaired numerical analytic equation. At least eighteen subjects for each group should include in this study. With the ten percent dropout possibility, twenty subjects will be recruited for each group, resulting in a total sample size of 40 subjects. All subjects would be recruited with a consecutive sampling method and randomly assigned into two groups, the TCI propofol group and sevoflurane group. Block random allocation was done for all subjects by using the random allocator program Winpepi.

Study Protocols Peripheral venous catheters were placed in all subjects. Subjects in the TCI propofol group had one specific intravenous catheter for propofol infusion apart from medication or intravenous fluid line. In comparison, subjects in the sevoflurane group were cannulated only with one venous catheter. Midazolam 0.05 mg/kg BW and fentanyl 1 mcg/kg BW were given as premedication. Subjects in the TCI Propofol group received TCI propofol (Schneider) with targeted Ce 4 -5 mcg/ml for anesthesia induction and maintenance. Subjects in the sevoflurane group received intravenous propofol 1 - 2 mg/kg BW. BIS scores in both groups was titrated down to 50. Laryngeal mask no.3 or no.4 was inserted three minutes after administering atracurium 0.25 mg/kg BW. All subjects were ventilated with tidal volume 8 ml/kg BW, 12 times/minutes, oxygen fraction 50%.

Subjects in the TCI propofol group received TCI propofol for anesthesia maintenance, Ce value was titrated until a targeted BIS score of 40-60 achieved. Subjects in the sevoflurane group received sevoflurane 2 volume%, which were titrated up/down every 5 minutes to get a targeted BIS score of 40-60. Blood pressure, heart rate, oxygen saturation, and BIS score were monitored every 5 minutes. Fentanyl 1 mcg/ kg BW was added if there was an increase in blood pressure, heart rate and or BIS score that couldn't be overcome by increasing the dose of TCI propofol or sevoflurane.

Surgery was considered done when the palpebral retractor had been removed. After spontaneous ventilation reverted, neostigmine 0.04 mg/kg BW and atropine 0.04 mg/kg BW as a reversal agent were given. Laryngeal mask was removed when the anesthesia still deep enough and subjects were monitored afterward. Time when TCI propofol and sevoflurane were discontinued was recorded (T0). Time when the patient was fully awake and could follow simple orders such as raising hands was recorded (Tp). Recovery time was the duration from T0 to Tp. Unwanted events during recovery, such as agitation and nausea-vomiting were recorded. Total fentanyl usage during surgery was also recorded. Statistical analysis was performed using Statistical Product for Social Sciences (SPSS) software 21.0 for windows. T-Test or Mann-Whitney analysis was done depending on the data normality test.

Being tested
TCI Propofol, Sevoflurane
Keywords
vitrectomy, propofol, sevoflurane, TCI
Medical subject headings
Vitreous Detachment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TCI PropofolProcedure or surgery

    Peripheral venous catheters were placed in all subjects. Subjects in the TCI propofol group had one specific intravenous catheter for propofol infusion apart from medication or intravenous fluid line. Subjects in the TCI Propofol group received TCI propofol (Schneider) with targeted Ce 4 -5 mcg/ml for anesthesia induction and maintenance. Subjects in the TCI propofol group received TCI propofol for anesthesia maintenance, Ce value was titrated until a targeted BIS score of 40-60 achieved.

  • SevofluraneProcedure or surgery

    subjects in the sevoflurane group were cannulated only with one venous catheter. Midazolam 0.05 mg/kg BW and fentanyl 1 mcg/kg BW were given as premedication. Subjects in the sevoflurane group received intravenous propofol 1 - 2 mg/kg BW.

Study groups in NCT04865991
Study groupRoleWhat they receive
TCI propofol groupExperimentalSubjects in the TCI propofol group received TCI propofol for anesthesia maintenance, Ce value was titrated until a targeted BIS score of 40-60 achieved.
Receives: Procedure: TCI Propofol
sevoflurane groupActive comparatorSubjects in the sevoflurane group received sevoflurane 2 volume%, which were titrated up/down every 5 minutes to get a targeted BIS score of 40-60.
Receives: Procedure: Sevoflurane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recovery time

    Recovery time was the duration from T0 to Tp. Unwanted events during recovery, such as agitation and nausea-vomiting were recorded.

    Measured: 2 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start1 Sep 2017
  3. Primary completion31 Dec 2017
  4. Study completion31 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04865991
Sponsor's protocol ID
IndonesiaUAnes101
Status last verified
Apr 2021
First submitted
26 Apr 2021
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TCI Propofol and Sevoflurane in people with Vitreous Detachment, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery time (time frame: 2 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.

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