Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865991
Status:
COMPLETED
Last Update Posted:
2021-04-29
First Post:
2021-04-26
Brief Title:
Comparison of Propofol Target Controlled Infusion TCI and Sevoflurane
Sponsor:
Indonesia University
Organization:
Indonesia University
Study Overview
Official Title:
Comparison of Propofol Target Controlled Infusion TCI and Sevoflurane Recovery Time in Vitrectomy Surgery a Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 879UN2F1ETIK2017 and informed consent patients aged 18-65 years old body mass index 18 - 30 kgm2 American Society of Anesthesiologists ASA status I-II who were scheduled for vitrectomy surgery under general anesthesia at Kiranas 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 879UN2F1ETIK2017 and informed consent patients aged 18-65 years old body mass index 18 - 30 kgm2 American Society of Anesthesiologists ASA status I-II who were scheduled for vitrectomy surgery under general anesthesia at Kiranas 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 005 mgkg BW and fentanyl 1 mcgkg BW were given as premedication Subjects in the TCI Propofol group received TCI propofol Schneider with targeted Ce 4 -5 mcgml for anesthesia induction and maintenance Subjects in the sevoflurane group received intravenous propofol 1 - 2 mgkg BW BIS scores in both groups was titrated down to 50 Laryngeal mask no3 or no4 was inserted three minutes after administering atracurium 025 mgkg BW All subjects were ventilated with tidal volume 8 mlkg BW 12 timesminutes 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 updown 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 couldnt 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 004 mgkg BW and atropine 004 mgkg 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 210 for windows T-Test or Mann-Whitney analysis was done depending on the data normality test
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 005 mgkg BW and fentanyl 1 mcgkg BW were given as premedication Subjects in the TCI Propofol group received TCI propofol Schneider with targeted Ce 4 -5 mcgml for anesthesia induction and maintenance Subjects in the sevoflurane group received intravenous propofol 1 - 2 mgkg BW BIS scores in both groups was titrated down to 50 Laryngeal mask no3 or no4 was inserted three minutes after administering atracurium 025 mgkg BW All subjects were ventilated with tidal volume 8 mlkg BW 12 timesminutes 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 updown 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 couldnt 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 004 mgkg BW and atropine 004 mgkg 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 210 for windows T-Test or Mann-Whitney analysis was done depending on the data normality test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None