Determination of ED50 and ED95 With Clinical Efficacy of Intranasal Dexmedetomidine Combined With Esketamine for Preoperative Sedation in Pediatric General Anesthesia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12-72
SponsorSecond Affiliated Hospital of Wenzhou Medical University

About this trial

For pediatric patients undergoing general anesthesia, poor anesthesia induction compliance often has adverse effects on individual behavior in the early postoperative period. Dexmedetomidine can reduce the cardiovascular responses and postoperative mental adverse reactions caused by esketamine anesthesia induction \[6\]. This study aims to explore the ED50 and ED95 and clinical effects of the combination of dexmedetomidine and esketamine nasal drops for preoperative sedation in children of different ages undergoing general anesthesia, providing a theoretical basis for the combined use of dexmedetomidine and esketamine for preoperative sedation in children undergoing general anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA physical status classification Grade I or II;

Age 1-6 years old;

Children who need to undergo general anesthesia for elective surgery;

Weight within the normal range;

Disqualifiers

The child's guardian or the child themselves refuses to participate in the study;

Patients with contraindications for sedation/anesthesia or a history of abnormal recovery from sedation/anesthesia;

Individuals known to be allergic to the study drugs, opioid drugs, or rescue medications;

Individuals with a history of heart, brain, liver, kidney, or metabolic diseases;

Trial design

Design model

Sequential

Treatments tested in this trial

  • dexmedetomidine

    Drug

    esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.

  • Esketamine

    Drug

    esketamine 0.5mg/kg intranasally via a nasal dropper, dexmedetomidine 1μg/kg was given intranasally, and the adjusted dose of dexmedetomidine was 0.25μg/kg.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: 1-3 years oldExperimental treatment 2 interventions
Group B: 3-6 years oldExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Onset time of sedation

After drug administration, every 5 minutes, an anesthesiologist who was unaware of the medication used assessed the sedation level using the Ramsay Sedation Scale(RSS).Within 30 minutes after the intranasal medication was administered, the Ramsay Sedation Score (RSS) was ≥4.

Time frame
Within 30 minutes after intranasal administration of dexmedetomidine.

Secondary outcomes

1

Intravenous cannulation success rates

Emotional State Score 1. Calm 2. Apprehensive, not smiling, tentative behavior, withdrawn 3. Crying 4. Thrashing, crying with movements of the arms and legs, resisting

Time frame
30 minutes after intranasal administration of dexmedetomidine.
2

Awakening time

From the closure of the sevoflurane vaporizer to the time when the patient opened their eyes.

Time frame
Within 1 hour of entering the Post Anesthesia Care Unit (PACU).
3

Postoperative agitation

The pediatric anesthesia emergence delirium scale consists of five items. Each item is scored 0-4 yielding a total between 0 and 20. The degree of emergence delirium increased directly with the total score. pediatric anesthesia emergence delirium scale ≥12 at any time indicates presence of emergence delirium.

Time frame
Within up to 15-30 minutes after child's first eye opening in the postoperative period
4

Number of children with adverse effects

1、Bradycardia and/or hypotension need for hemodynamic support; 2、Desaturation is defined as Oxygen desaturation \<90%; 3、Nausea and vomiting; 4、Any adverse effects requiring interventions.

Time frame
Up to 24 hours including preoperative, intraoperative, and postoperative periods

Other outcomes

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