Comparing Two Doses of Midazolam With Added Dexmedetomidine for Kids Before Surgery
- Conditions
- Preoperative Anxiety Experienced by the Pediatric PatientPreoperative Anxiety
- Interventions
- Drug: Dexmedetomidine + Midazolam 0.4 mg/kgDrug: Dexmedetomidine + Midazolam 0.2 mg/kg
- Registration Number
- NCT06979791
- Lead Sponsor
- Cairo University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Pediatric patients aged 1 to 8 years
- Scheduled for elective surgery under general anesthesia
- Surgery duration < 1 hour
- ASA physical status I or II
- Parent or legal guardian able to provide informed consent
- Refusal to participate by parent/guardian
- Nasal infections, pathology, or epistaxis
- Runny nose or upper respiratory tract infection
- Enlarged adenoids
- BMI > 30
- Known allergy to dexmedetomidine or midazolam
- Fever on day of surgery
- Coagulopathy
- Scheduled for cardiothoracic or neurosurgical procedures
- Congenital heart disease
- Neurological or mental disorders
- Pre-existing sedation (MOASS < 5) on the day of surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexmedetomidine + Midazolam 0.4 mg/kg Dexmedetomidine + Midazolam 0.4 mg/kg - Dexmedetomidine + Midazolam 0.2 mg/kg Dexmedetomidine + Midazolam 0.2 mg/kg -
- Primary Outcome Measures
Name Time Method Mask Acceptance Score (MAS) at time of induction At the time of induction (approximately 30 minutes after premedication) 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.
- Secondary Outcome Measures
Name Time Method Heart Rate Baseline and immediately before anesthesia induction. 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.
Child-Parent Separation Score Approximately 30 minutes after premedication (at time of separation) 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 to Recovery (Modified Aldrete Score ≥ 9) From extubation until Modified Aldrete Score ≥9 is achieved, assessed up to 1 hour in the Post-Anesthesia Care Unit (PACU) The time from extubation to achieving a Modified Aldrete Score of ≥9 will be recorded.
Sedation Level (MOASS) at 15 and 30 minutes after premedication 15 minutes and 30 minutes after drug administration 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.
Blood Pressure Baseline and immediately before anesthesia induction 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.
Perioperative Adverse Events From the time of drug administration until 1 hour post-discharge from the Post-Anesthesia Care Unit (PACU), or until the occurrence of a recorded adverse event, whichever comes first. Incidence of adverse effects such as nasal irritation, nausea, vomiting, paradoxical reactions, respiratory depression, etc., will be recorded and compared between groups.
Trial Locations
- Locations (2)
Kasr Al-Ainy Hospital, Cairo University
🇪🇬Cairo, Egypt
Souad Kafafi University Hospital, Misr University for Science and
🇪🇬Giza, Egypt