Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03795259 |
| Other study ID # |
83045809-604.01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 28, 2018 |
| Est. completion date |
May 19, 2019 |
Study information
| Verified date |
April 2021 |
| Source |
Istanbul University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Sugammadex is the first selective relaxant binding agent approved to reverse certain
non-depolarizing neuromuscular drugs in patients 2 years old and above. Although it has been
in use over the last 10 years, more pharmacological studies are needed to understand its
overall effects on participants.
As investigators' primary outcome, the investigators aimed to investigate how differently
sugammadex reverses neumuscular blockade caused by rocuronium under general anesthesia
maintenance with sevoflurane compared with desflurane. Also, to compare the changes in peak
airway pressure. As investigators' secondary outcome, the investigators aimed to compare the
changes in heart rate and blood pressures after sugammadex injection under sevoflurane and
desflurane general anesthesia.
Description:
160 participants aged between 2-10 years old and scheduled for lower urinary tract or minor
abdominal surgery will be enrolled in the study. Each participant will be assigned
sevoflurane (Group S) or desflurane (Group D) anesthesia at enrollment by drawing lots.
Parental consent after written and verbal information will be asked on the morning of the
surgery.
Participants will be premedicated with midazolam (0.05 mg/kg, Zolamid, Defarma-Turkey) and
ketamine (0.1 mg/kg, Ketalar, Pfizer-USA) and brought into operating theater. Routine
monitoring will be done with non-invasive blood pressure (every 5 minutes), continuous
peripheral oxygen saturation, continuous 3-lead ECG, body temperature and continuous
end-tidal carbon dioxide measurements. Participants will be actively warmed to ensure
normo-thermia. Train-of-four (TOF) measurements will be performed on the arm without the
vascular access.
Anesthesia will be induced with thiopenthal (5-6 mg/kg, Pental, Ulagay-Turkey) and fentanyl
(2 mcg/kg, Talinat, VEM-Turkey). After the participant loses consciousness, TOF calibration
will be performed and baseline value will be recorded. Then 0.6 mg/kg rocuronium (Myocron,
VEM-Turkey) will be given intravenously and serial TOF measurements at 15 seconds intervals
will be taken. The time from TOF of 100% to 0% will be recorded as T1. Participant will be
orotracheal intubated when the TOF value is 0%. All the patients will be ventilated with
Datex Ohmeda S/5 Avance in a volume controlled ventilation mode (air-oxygen mixture, FiO2:
40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Participant will receive 2%
sevoflurane (Sevoran, Abbvie-Italy) or 6% desflurane (Suprane, Baxter-Belgium) according to
their groups.
Non-invasive blood pressure, heart rate and peak airway pressure will be recorded at 5 minute
intervals after orotracheal intubation. Continuous TOF measurements will be taken until TOF
value reaches 25%. Time from TOF of 0% to 25% will be recorded as T2.
When the TOF value is 25%, 2 mg/kg sugammadex (Bridion, MSD-Greece) will be given
intravenously and TOF measurements will continue every 15 seconds. The time from sugammadex
injection (TOF of 25%) to TOF of 90% will be recorded as T3. Non-invasive blood pressure,
heart rate and peak airway pressure will be recorded at the time of sugammadex injection and
at 1st, 2nd, 3rd and 10th minutes. Any reactions to sugammadex will be recorded (anaphylaxis,
bronchospasm, etc.).
T1, T2 and T3 of Group S and D will be compared. Non-invasive blood pressure, heart rate and
peak airway pressure after sugammadex injection at time 0min, 1min, 2min, 3min and 10min will
be compared.
