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Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery

ConditionsPreoperative Anxiety Experienced by the Pediatric PatientPreoperative Anxiety
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-8
SponsorCairo University

About this trial

The goal of this this randomized controlled trial is to investigate if adding intranasal dexmedetomidine to two different doses of intranasal midazolam provides effective sedation with fewer side effects in pediatric patients aged 1 to 8 years undergoing elective surgeries. The main questions it aims to answer are:

Does combining intranasal dexmedetomidine with a reduced dose of midazolam achieve adequate sedation while minimizing adverse effects?

How do different dosing regimens affect mask acceptance, parent separation, sedation levels, recovery times, and perioperative adverse events?

Researchers will compare two groups: one receiving dexmedetomidine plus a higher dose of midazolam (0.4 mg/kg) and another receiving dexmedetomidine plus a lower dose of midazolam (0.2 mg/kg) to see if the reduced dose maintains sedation effectiveness while reducing side effects.

Participants will:

Receive intranasal dexmedetomidine (2 mcg/kg) combined with either 0.4 mg/kg or 0.2 mg/kg of intranasal midazolam.

Undergo sedation scoring at 15 and 30 minutes after drug administration.

Be assessed for ease of separation from parents and acceptance of anesthesia mask.

Be monitored for vital signs, recovery times, and any perioperative adverse events.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pediatric patients aged 1 to 8 years

Scheduled for elective surgery under general anesthesia

Surgery duration < 1 hour

ASA physical status I or II

Disqualifiers

Refusal to participate by parent/guardian

Nasal infections, pathology, or epistaxis

Runny nose or upper respiratory tract infection

Enlarged adenoids

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine + Midazolam 0.4 mg/kg

    Drug

    Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.4 mg/kg, administered 30 minutes before the induction of general anesthesia.

  • Dexmedetomidine + Midazolam 0.2 mg/kg

    Drug

    Participants in this arm will receive intranasal dexmedetomidine at a dose of 2 mcg/kg combined with intranasal midazolam at a dose of 0.2 mg/kg, administered 30 minutes before the induction of general anesthesia.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Dexmedetomidine + Midazolam 0.4 mg/kgExperimental treatment 1 intervention
Group B: Dexmedetomidine + Midazolam 0.2 mg/kgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mask Acceptance Score (MAS) at time of induction

Mask acceptance will be assessed at the time of anesthesia induction using the Mask Acceptance Score (MAS). A score of 1 or 2 will be considered satisfactory (excellent/good), while scores of 3 or 4 will be considered unsatisfactory. The percentage of children with satisfactory mask acceptance will be compared between groups.

Time frame
At the time of induction (approximately 30 minutes after premedication)

Secondary outcomes

1

Sedation Level (MOASS) at 15 and 30 minutes after premedication

Sedation will be evaluated using the Modified Observer's Assessment of Alertness/Sedation Scale (MOASS). Scores will be recorded at 15 and 30 minutes after intranasal drug administration.

Time frame
15 minutes and 30 minutes after drug administration
2

Child-Parent Separation Score

Measured using the Child-Parent Separation Scale at the time of separation from parents. Scores of 1 or 2 indicate satisfactory separation; score of 3 indicates poor separation.

Time frame
Approximately 30 minutes after premedication (at time of separation)
3

Heart Rate

Heart rate will be monitored at baseline and at the time of transfer to the operating room. Mean heart rate values will be compared between the two groups.

Time frame
Baseline and immediately before anesthesia induction.
4

Blood Pressure

Mean blood pressure will be monitored at baseline and at the time of transfer to the operating room. Mean blood pressure values will be compared between the two groups.

Time frame
Baseline and immediately before anesthesia induction

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Misr University for Science and Technology

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: