Clinical trial NCT03795259: Effect of Rocuronium and Sugammadex Under Sevoflurane and Desflurane Anesthesia in Children
Official title: Effect of Rocuronium and Sugammadex Under Sevoflurane and Desflurane Anesthesia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthetics, Inhalation
Neuromuscular Blockade
Anesthesia, General
Keywords: Sugammadex
Sevoflurane
Desflurane
Rocuronium
TOF
Child
Train-of-four
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: GAMZE PİRİNÇ ŞAŞIOĞLU
name: GÜNER KAYA
name: Ayse Cigdem Tutuncu
First posted: 2019-01-07
Enrollment: 148
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Lower urinary tract surgery (cystoscopy, examination under general anaesthesia, circumcision etc.) and inguinal hernia surgery expected no to last more than 2 hours
* ASA I-II

Exclusion Criteria:

* Liver and failure
* Upper airway infection
* Asthma
* Exposure to second hand smoke
* Kidney failure
* Obesity (BMI\> 30%)
* Rocuronium allergy
* Muscle disease (myasthenia gravis, muscular dystrophies, etc.)
* Calcium channel blocker use
* Patient or family refusal

Primary outcomes:
measure: Time from TOF of 25% to 90% after 2 mg/kg sugammadex injection
timeFrame: Up to end of surgery
measure: Time from TOF of 100% to 0% after 0.6 mg/kg rocuronium injection
timeFrame: Up to end of surgery
measure: Time from TOF of 0% to 25% after orotracheal intubation
timeFrame: Up to end of surgery
measure: Sugammadex effects on respiratory parameters
timeFrame: Up to 10 minutes post-administration of study intervention
Secondary outcomes:
measure: Sugammadex effects on heart rate
timeFrame: Up to 10 minutes post-administration of study intervention
measure: Sugammadex effects on systolic and diastolic blood pressures
timeFrame: Up to 10 minutes post-administration of study intervention
measure: Percentage of Participants Experiencing an Adverse Event (AE) after Administration of Study Intervention
timeFrame: Intraoperative and postoperative first 24 hour.
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty
state: Please Select
Study officials:
affiliation: Istanbul University Cerrahpasa Medical Faculty
name: Guner Kaya, Prof.
role: STUDY_DIRECTOR
References: