Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane
Primary Purpose
Vitreous Detachment
Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
TCI Propofol
Sevoflurane
Sponsored by
About this trial
This is an interventional treatment trial for Vitreous Detachment focused on measuring vitrectomy, propofol, sevoflurane, TCI
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with hemodynamic instability, allergy, raised intracranial pressure, and a history of hyperthermia malignant
Sites / Locations
- Cipto Mangunkusumo Cental National Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
TCI propofol group
sevoflurane group
Arm Description
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.
Outcomes
Primary Outcome Measures
Recovery time
Recovery time was the duration from T0 to Tp. Unwanted events during recovery, such as agitation and nausea-vomiting were recorded.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04865991
Brief Title
Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane
Official Title
Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane Recovery Time in Vitrectomy Surgery: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
March 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Detachment
Keywords
vitrectomy, propofol, sevoflurane, TCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TCI propofol group
Arm Type
Experimental
Arm Description
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.
Arm Title
sevoflurane group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
TCI Propofol
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sevoflurane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recovery time
Description
Recovery time was the duration from T0 to Tp. Unwanted events during recovery, such as agitation and nausea-vomiting were recorded.
Time Frame
2 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients with hemodynamic instability, allergy, raised intracranial pressure, and a history of hyperthermia malignant
Facility Information:
Facility Name
Cipto Mangunkusumo Cental National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Propofol Target Controlled Infusion (TCI) and Sevoflurane
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