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Completed

NCT Number: NCT03795259

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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Please Select, 34098, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rocuronium

Drug

After induction, rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%.

Other names: Esmeron, MSD

Sugammadex

Drug

Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given intravenously.

Other names: Bridion, MSD

Primary outcomes

  1. Time from TOF of 25% to 90% after 2 mg/kg sugammadex injection

    Time frame: Up to end of surgery

    When the TOF value reaches 25% from 0% after the anesthesia induction, 2 mg/kg sugammadex will be given to reverse neuromuscular blockade. Continuous TOF monitoring will continue every 15 seconds. The time it takes for TOF to reach 90% is the primary outcome.

  2. Time from TOF of 100% to 0% after 0.6 mg/kg rocuronium injection

    Time frame: Up to end of surgery

    After induction of anesthesia a baseline TOF will be recorded (anticipated 100%). 0.6 mg/kg rocuronium will be injected and TOF will be measured every 15 seconds. The time it takes for TOF to reach 0% is the second primary outcome.

  3. Time from TOF of 0% to 25% after orotracheal intubation

    Time frame: Up to end of surgery

    After TOF reaches 0%, orotracheal intubation will be performed. Continuous TOF monitoring will be done every 5 minutes in first 15 minutes and every 15 seconds afterwards. No additional neuromuscular blocking drugs will be given. The time it takes for TOF to reach 25% is the third primary outcome.

  4. Sugammadex effects on respiratory parameters

    Time frame: Up to 10 minutes post-administration of study intervention

    Peak airway pressure observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes.

Secondary outcomes

  1. Sugammadex effects on heart rate

    Time frame: Up to 10 minutes post-administration of study intervention

    Heart rate observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes.

  2. Sugammadex effects on systolic and diastolic blood pressures

    Time frame: Up to 10 minutes post-administration of study intervention

    blood pressures observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes.

  3. Percentage of Participants Experiencing an Adverse Event (AE) after Administration of Study Intervention

    Time frame: Intraoperative and postoperative first 24 hour.

    Observation bronchospasm and anaphylaxis after sugammadex injection

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

  • Ayse Cigdem Tutuncu
  • GAMZE PİRİNÇ ŞAŞIOĞLU
  • GÜNER KAYA

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 7, 2019
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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