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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, General; Anesthetics, Inhalation; Neuromuscular Blockade
• Intervention / Treatment: Drug: Rocuronium; Drug: Sugammadex

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.

• Study Type: Interventional
• Enrollment (Actual): 148
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Please Select
    • Istanbul, Please Select, Turkey, 34098
      • Istanbul University Cerrahpasa Medical Faculty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Sevoflurane; Anesthesia will be induced with thiopenthal 5-6 mg/kg and fentanyl 2 mcg/kg. Then rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%. Anesthesia will continue with 2% sevoflurane while the patient is ventilated in volume controlled mode (FiO2: 40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given to measure the time for TOF to reach 90%.	Drug: Rocuronium; 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; Drug: Sugammadex; 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
ACTIVE_COMPARATOR: Desflurane; Anesthesia will be induced with thiopenthal 5-6 mg/kg and fentanyl 2 mcg/kg. Then rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%. Anesthesia will continue with 6% desflurane while the patient is ventilated in volume controlled mode (FiO2: 40%, I/E: 1/1.5, PEEP: 5 cmH2O, tidal volume: 8ml/kg). Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given to measure the time for TOF to reach 90%.	Drug: Rocuronium; 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; Drug: Sugammadex; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from TOF of 25% to 90% after 2 mg/kg sugammadex injection	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.	Up to end of surgery
Time from TOF of 100% to 0% after 0.6 mg/kg rocuronium injection	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.	Up to end of surgery
Time from TOF of 0% to 25% after orotracheal intubation	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.	Up to end of surgery
Sugammadex effects on respiratory parameters	Peak airway pressure observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes.	Up to 10 minutes post-administration of study intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sugammadex effects on heart rate	Heart rate observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes.	Up to 10 minutes post-administration of study intervention
Sugammadex effects on systolic and diastolic blood pressures	blood pressures observed at and after sugammadex injection at 1st, 2nd, 3rd and 10th minutes.	Up to 10 minutes post-administration of study intervention
Percentage of Participants Experiencing an Adverse Event (AE) after Administration of Study Intervention	Observation bronchospasm and anaphylaxis after sugammadex injection	Intraoperative and postoperative first 24 hour.

Collaborators and Investigators

• Sponsor: Istanbul University
• Collaborators: Ayse Cigdem Tutuncu; GAMZE PİRİNÇ ŞAŞIOĞLU; GÜNER KAYA
• Investigators: Study Director: Guner Kaya, Prof., Istanbul University Cerrahpasa Medical Faculty

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 28, 2018
• Primary Completion (ACTUAL): May 19, 2019
• Study Completion (ACTUAL): May 19, 2019

Study Registration Dates

• First Submitted: December 27, 2018
• First Submitted That Met QC Criteria: January 4, 2019
• First Posted (ACTUAL): January 7, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: April 29, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Child; Desflurane; Sevoflurane; Rocuronium; Sugammadex; TOF; Train-of-four
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration; Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: 83045809-604.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No