Dexmetomidine in Children Undergoing General Anaesthesia

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ClinicalTrials.gov Identifier: NCT03923075

Recruitment Status : Completed

First Posted : April 22, 2019

Last Update Posted : November 6, 2020

Sponsor:

Information provided by (Responsible Party):

Paraskevi Matsota, Attikon Hospital

Study Description

Brief Summary:

The effects of dexmedetomidine on the onset of both the general anaesthesia induction and the neuromuscular blockade in children of school age will be investigated. Ten minutes before the induction of general anaesthesia, the first group will receive continuous infusion of dexmedetomidine (DEX group), while the second group will receive normal saline (Placebo group).

Condition or disease	Intervention/treatment	Phase
Anesthesia	Drug: Dexmedetomidine Other: 0.9% saline	Not Applicable

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Detailed Description:

Children 4 to 12 years old, ASA I-II, scheduled for elective minor or medium procedure under general anaesthesia will be included in the study, after written informed concern from their parents has been obtained. Participants will be randomly allocated according to the type of the solution infused 10 minutes before the induction of general anaesthesia into one of the following two groups using the closed envelop method.

DEX group: patients will receive 0.5μcg/kg IV bolus of dexmedetomidine in 10 min, right before the induction of general anaesthesia. The concentration of dexmedetomidine solution is 0.2μcg/ml, (100μcg of dexmedetomidine are diluted in 50ml N/S 0.9%), which corresponds to volume (ml) calculated by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25".

Placebo group: patients will receive N/S 0.9% IV in 10 min, right before the induction of general anaesthesia. The volume infused (ml) is determined by the same type: "body weight (Kg)/4 or body weight (Kg) X 0.25".

The above solutions will be prepared by the anaesthetist who will provide the anaesthesia and will not be known to the anaesthetist who will record the study's measurements.

No premedication will be given. All children will receive the same anaesthesia induction scheme.

Once the patients have entered the operating theater, standard monitoring will be applied (NIBP, ECG, SpO2) and an IV line will be inserted. Depth of anaesthesia and monitoring of neuromuscular blockade will be recorded by BIS and TOF, respectively. Afterwards continues infusion of dexmedetomidine or N/S 0.9% will be initiated, depending on the assigned group, for duration of 10 min.

Right after the end of the infusion, we will proceed to the induction of anaesthesia with 3mg/kg of propofol and 2μcg/kg of fentanyl and when BIS<60 will be achieved, rocuronium will be administered at a dose of 0.7 mg/kg . Right afterwards, neuromuscular blockade will be estimated using the TOF acceleromyography (4 supramaximal twitches, 0.5sec interval in 2sec, frequency 2Hz, intensity 50mA). TOF will be repeated every 15sec. At the same time, ventilation of the patient will be supported with a bag and mask (Ο2 100%). When TOF=0 will be achieved, the patient will be intubated. After intubation, anaesthesia will be maintained with sevoflurane 1 MAC in 50% O2/Air.

The intubation conditions will be estimated using the Viby-Mogensen score (scale of 5 parameters). Also, number of intubation attempts will be recorded.

The study period is from "right before the start" of the dexmedetomidine or the N/S 0.9% infusion up to 5 min after the tracheal intubation. The following time points will be recorded:

Start time of the IV infusion of dexmedetomidine or N/S 0.9% (tstart) End time of the IV infusion of dexmedetomidine or N/S 0.9% (tend) Time of propofol injection (tprop) Time of achieving BIS<60 (tBIS<60) Time from propofol injection to achieve BIS<60 (tprop - tBIS<60) in min Time of rocuronium injection (troc) Time of achieving TOF=0 (tTOF=0) Time from rocuronium injection to TOF=0 (troc - tTOF=0) in min Time that intubation performed (tintubation)

Measurements Heart rate (HR), systolic arterial pressure (SAP), SpO2 and BIS will be recorded at the following time points: just before the start of infusion of dexmedetomidine or N/S 0.9% (tbaseline) and afterwards every 3 min during the infusion, as well as at the particular time points tend, tprop, tBIS<60, troc, tTOF=0, tintubation and 5 min after the intubation. Viby-Mogensen score and number of intubation attempts will also be recorded.

During the study period, any adverse effects or incidences like respiratory depression during the 10 min infusion of the study solutions, bradycardia (defined as >20% reduction of HR from the baseline values or as HR<60bpm), hypotension (defined as >20mmHg reduction of SAP from the baseline values), allergic reactions, bronchospasm and laryngospasm will be recorded. In case of bradycardia or hypotension, IV atropine 0.02μcg/kg or ephedrine 1-2μcg/kg will be administered, respectively. In case of persistent bradycardia despite the use of atropine, dexmedetomidine infusion will be stopped and the child will be excluded from the study.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Masking Description:	Single (Outcomes Assessor)
Primary Purpose:	Other
Official Title:	The Effects of Dexmedetomidine on Induction of Anaesthesia and Onset of Neuromuscular Blockade in Children
Actual Study Start Date :	May 2, 2019
Actual Primary Completion Date :	March 20, 2020
Actual Study Completion Date :	September 25, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Sodium chloride Dexmedetomidine

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Dexmedetomidine Drug: dexmedetomidine (Dexmed) solution(100μcg of dexmedetomidine in 50ml N/S 0.9%). given at a bolus dose of 0.5μcg/kg of the dexmedetomidine solution [that corresponds to the volume (ml) calculated by the type "body weight (Kg)/4 or body weight (Kg) X 0.25". THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY	Drug: Dexmedetomidine INFUSION BEFORE INDUCTION OF ANAESTHESIA Other Name: Dexmed
Placebo Comparator: 0.9 % saline Drug:0.9 % saline solution (Normal saline) given at a volume (ml) determined by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25" THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY	Other: 0.9% saline INFUSION BEFORE INDUCTION OF ANAESTHESIA Other Name: normal saline

Arm

Intervention/treatment

Active Comparator: Dexmedetomidine

Drug: dexmedetomidine (Dexmed) solution(100μcg of dexmedetomidine in 50ml N/S 0.9%). given at a bolus dose of 0.5μcg/kg of the dexmedetomidine solution [that corresponds to the volume (ml) calculated by the type "body weight (Kg)/4 or body weight (Kg) X 0.25".

THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY

Drug: Dexmedetomidine

INFUSION BEFORE INDUCTION OF ANAESTHESIA

Other Name: Dexmed

Placebo Comparator: 0.9 % saline

Drug:0.9 % saline solution (Normal saline) given at a volume (ml) determined by the type: "body weight (Kg)/4 or body weight (Kg) X 0.25" THE SOLUTION IS GIVEN AS CONTINUOUS INFUSION 10 MINUTES BEFORE THE INDUCTION OF GENERAL ANAESTHESIA IN CHILDREN UNDERGOING ELECTIVE SURGERY

Other: 0.9% saline

INFUSION BEFORE INDUCTION OF ANAESTHESIA

Other Name: normal saline

Outcome Measures

Primary Outcome Measures :

Onset of neuromuscular blockade [ Time Frame: Up to 5 minutes after the injection of rocuronium ]
Neuromuscular blockade is estimated with TOF acceleromyography, while onset of neuromuscular blockaded is defined as the time needed to achieve TOF=0 after the injection of rocuronium.

Secondary Outcome Measures :

Onset of anaesthesia induction [ Time Frame: Up to 15 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively ]
The depth of anaesthesia is monitored using the BIS device (range 0-100). Onset of anesthesia is defined as the time needed to achieve BIS value<60, after the injection of propofol.
Number of participants who developed bradycardia [ Time Frame: Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively ]
Bradycardia is defined as >20% reduction of HR from the baseline values or as HR<60bpm using ECG monitoring.
Number of participants who developed hypotension [ Time Frame: Up to 30 minutes after the initiation of the infusion of dexmedemoditine or normal saline, respectively ]
Hypotension is defined as >20mmHg reduction of SAP from the baseline values using noninvasive monitoring of arterial pressure

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	4 Years to 12 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

children underoing elective surgery under general anaesthsia
age 4-12 years old
ASA I-II

Exclusion Criteria:

patient or parent refusal
Mallampati score> 3
BMI>35
severe systemic cardiac disease
neuromuscular disease
recent respiratory infection
drug allergy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923075

Locations

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Greece
2nd Department of Anesthesiology, Attikon University Hospital
Athens, Attiki, Greece, 12462

Sponsors and Collaborators

Attikon Hospital

Investigators

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Study Chair:	Georgia K Kostopanagiotou	2nd Department of Anaesthesiology, "Attikon" University Hospital
Principal Investigator:	Paraskevi K Matsota	2nd Department of Anaesthesiology, "Attikon" University Hospital

More Information

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Responsible Party:	Paraskevi Matsota, Assoc Prof of Anaesthesiology, Attikon Hospital
ClinicalTrials.gov Identifier:	NCT03923075
Other Study ID Numbers:	DEXAINMBCH
First Posted:	April 22, 2019 Key Record Dates
Last Update Posted:	November 6, 2020
Last Verified:	November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	restrictions due to regulation for personal data protection

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Paraskevi Matsota, Attikon Hospital:


dexmedetomidine propofol rocuronium TOF children

Additional relevant MeSH terms:

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Dexmedetomidine Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents	Peripheral Nervous System Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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