Neuromuscular Blockade Clinical Trial
Official title:
Effect of Rocuronium and Sugammadex Under Sevoflurane and Desflurane Anesthesia in Children
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05558969 -
The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex
|
N/A | |
Completed |
NCT03168308 -
Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients
|
Phase 4 | |
Not yet recruiting |
NCT03978780 -
Erector Spinae Block vs. Placebo Block Study
|
N/A | |
Completed |
NCT02892045 -
Mindray Neuromuscular Transmission Transducer
|
||
Completed |
NCT02912039 -
Electromyographic Assessment of the TetraGraph in Normal Volunteers
|
||
Completed |
NCT03427385 -
Minimum Local Anesthetic Dose for Adductor Canal Block
|
N/A | |
Completed |
NCT01450813 -
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
|
N/A | |
Completed |
NCT00535496 -
Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698)
|
Phase 3 | |
Recruiting |
NCT05794503 -
Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex
|
Early Phase 1 | |
Not yet recruiting |
NCT05993390 -
Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients
|
N/A | |
Recruiting |
NCT04609410 -
Bleeding in Laparoscopic Liver Surgery
|
N/A | |
Terminated |
NCT03649672 -
The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor
|
N/A | |
Completed |
NCT05687253 -
Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery
|
Phase 2 | |
Completed |
NCT05474638 -
Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery
|
N/A | |
Completed |
NCT05120999 -
Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
|
||
Completed |
NCT03572413 -
The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis.
|
Phase 4 | |
Completed |
NCT03608436 -
The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery
|
Phase 4 | |
Recruiting |
NCT02930629 -
Residual Block in Postoperative Anaesthetic Care Unit
|
N/A | |
Completed |
NCT02932254 -
Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex
|
Phase 4 | |
Completed |
NCT01828385 -
Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex
|
Phase 4 |