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Research Article | Volume 17 Issue 11 (None, 2025) | Pages 141 - 145
Pharmacokinetics and Efficacy of Dexmedetomidine as an Adjuvant to General Anesthesia in Pediatric Patients
 ,
 ,
1
Assistant Professor, Department of Pediatrics, PSP Medical College Hospital and Research Institute,Tambaram - Kanchipuram Main Road,Oragadam, Panruti,Tamil Nadu - 631604,India.
2
Assistant Professor, Department of Anaesthesia, PSP Medical College Hospital and Research Institute, Kanchipuram Main Road, Oragadam, Panruti, Kancheepuram, Tamil Nadu - 631604, India.
3
Associate Professor, Department of Anaesthesia, Chettinad Medical College, Chennai.
Under a Creative Commons license
Open Access
Received
Nov. 4, 2026
Revised
Nov. 10, 2026
Accepted
Nov. 22, 2026
Published
Nov. 28, 2026
Abstract

Background: Dexmedetomidine, a highly selective agonist of the α2-adrenergic receptor, has garnered heightened interest in paediatric anaesthesia due to its sedative, analgesic, and sympatholytic effects, all while minimising respiratory depression. Dexmedetomidine, when used as an adjunct to general anaesthesia, may enhance perioperative haemodynamic stability, diminish the need for anaesthetics and opioids, and promote a more seamless postoperative recovery. This research assessed the pharmacokinetics and effectiveness of dexmedetomidine as a supplementary agent to general anaesthesia in paediatric patients undergoing elective surgeries. Methods: This study was conducted at the Department of Paediatrics, PSP Medical College Hospital and Research Institute,Tambaram - Kanchipuram Main Road,Oragadam, Panruti,Tamil Nadu between September 2024 to October 2025. A forward-looking comparison investigation was performed on 40 paediatric subjects aged 2 to 12 years who were scheduled for elective surgery with general anaesthesia. Subjects were randomly assigned to two cohorts: Group D (n = 20) was administered intravenous dexmedetomidine (first dose of 0.5 µg/kg over 10 minutes, subsequently infused at 0.3 µg/kg/h), whereas Group C (n = 20) underwent conventional general anaesthesia devoid of dexmedetomidine. Pharmacokinetic metrics such as peak plasma concentration (Cmax), elimination half-life (t½), clearance (CL), and volume of distribution (Vd) were assessed thru sequential blood collection. The clinical effectiveness was evaluated by intraoperative haemodynamic metrics, anaesthetic demands, postoperative pain assessments, emergence agitation, recovery attributes, and adverse occurrences. Results:The study population had a mean age of 6.8 ± 2.9 years, and all groups had similar baseline characteristics. The elimination half-life, volume of distribution, clearance, and mean Cmax of dexmedetomidine in Group D were 1.9 ± 0.5 hours, 0.82 ± 0.18 L/kg/h, and 0.78 ± 0.14 ng/mL, respectively. The variability of intraoperative heart rate and blood pressure was considerably lower in patients given dexmedetomidine compared to controls (p < 0.05). In Group D, the total amount of inhalational anaesthetic needed was 22.4% less, and there was a substantial decrease in postoperative pain scores in the first 12 hours after the operation (p < 0.01). Two patients (10.0%) in Group D experienced agitation during an emergency, but eight patients (40%) in Group C did not. There was no notable decrease in respiratory function or any side effects noted. Conclusion:As an adjunct to general anaesthesia in paediatric patients, dexmedetomidine showed favourable pharmacokinetic properties and delivered substantial therapeutic advantages. The medication had a successful effect in improving haemodynamic stability, decreasing the need for anaesthesia, alleviating postoperative pain and agitation upon emergence, and it was safe to use. Hence, dexmedetomidine could be a useful supplement to paediatric anaesthesia that improves perioperative outcomes and the quality of recovery.

Keywords
INTRODUCTION

To guarantee sufficient unconsciousness, analgesia, immobility, and physiological stability during surgical procedures, general anaesthesia is commonly used in paediatric surgical practice. Problems specific to paediatric perioperative care persist despite innovations in anaesthetic methods; these include variations in haemodynamic status, higher anaesthetic needs, postoperative discomfort, emergence agitation, and side effects linked to opioid and inhalational anaesthetic usage. As a result, supplementary medications that enhance anaesthesia quality while reducing perioperative problems have garnered increasing attention [1-3].

 

Dexmedetomidine possesses sedative, analgesic, anxiolytic, and sympatholytic effects as a result of its preferential binding to the α2-adrenergic receptor. Particularly appealing for usage in paediatric patients is dexmedetomidine, which, in contrast to many traditional sedatives, induces a condition of cooperative sleep with minimal respiratory depression. Dexmedetomidine can alleviate pain and sedation by interacting with α2-receptors in the spinal cord and locus coeruleus, which in turn decrease activity in the sympathetic nervous system and alter transmission of nociceptive signals [4, 5].

 

A growing number of paediatric anaesthetic procedures in the last decade have included dexmedetomidine as an adjuvant to general anaesthesia. The medicine has been shown in multiple studies to have several beneficial effects after surgery, including reducing the need for intraoperative anaesthesia, easing postoperative pain, improving haemodynamic stability, decreasing narcotic intake, and lowering the incidence of emerging agitation. Restlessness, sobbing, disorientation, and inconsolability are symptoms of emergent agitation, a frequent postoperative behavioural disruption in children. This condition can hinder recovery and raise the likelihood of self-injury. One of dexmedetomidine's most useful clinical features is its capacity to decrease the frequency of emerging agitation [6-8].

 

It is crucial to understand the pharmacokinetics of dexmedetomidine in paediatric patients in order to optimise dosing regimens and ensure safe administration, in addition to its pharmacodynamic benefits. The processes of medication absorption, distribution, metabolism, and excretion change between children and adults according to age. The way drugs are disposed of in the body can be greatly affected by variables like metabolic rate, enzyme activity, renal function, and hepatic blood flow. To maximise therapeutic efficacy while minimising undesirable effects, pharmacokinetic assessment is critical for defining suitable dosing strategies [9, 10].

 

The pharmacokinetic characteristics of dexmedetomidine have shown some diversity in previous studies, especially when looking at different age groups and clinical contexts within paediatric populations. Data integrating pharmacokinetic features and perioperative efficacy is still scarce, despite multiple investigations investigating its clinical value. In order to provide recommendations based on evidence for the use of dexmedetomidine as an adjunct in paediatric anaesthesia, this knowledge is crucial [11, 12].

 

Therefore, the purpose of this research was to examine the pharmacokinetics and clinical effectiveness of dexmedetomidine in children having elective surgeries while under general anaesthesia. Anaesthesia needs, pharmacokinetic parameters, emerging agitation, postoperative pain management, recovery features, safety results, and intraoperative haemodynamic stability were the foci of the investigation [13].

 

 

MATERIALS AND METHODS

This prospective randomized comparative study was conducted at the Department of Paediatrics,PSP Medical College Hospital and Research Institute, Tambaram- Kanchipuram Main Road, Oragadam, Panruti,Tamil Nadu between September 2024 to October 2025. A total of 40 pediatric patients scheduled for elective surgery under general anesthesia were enrolled and randomly assigned into two groups. The primary objective of the research was to determine whether or not dexmedetomidine, when administered in conjunction with general anaesthesia, improved the safety and effectiveness of the surgery for paediatric patients having elective surgeries. All participants' parents or legal guardians provided written informed consent before the study began, and the research was approved by the Institutional Ethics Committee. Outcome Measures: The main result was a study of the pharmacokinetics of dexmedetomidine in children. Anaesthetic intake, intraoperative haemodynamic stability, postoperative pain scores, emerging agitation, recovery profile, and incidence of adverse events were included as secondary outcomes. Inclusion Criteria: 1. Children aged 2–12 years. 2. American Society of Anesthesiologists (ASA) physical status I or II. 3. Scheduled for elective surgery under general anesthesia. 4. Body weight appropriate for age. 5. Written informed consent obtained from parents or guardians. Exclusion Criteria: 1. Known hypersensitivity to dexmedetomidine. 2. Significant cardiovascular disease including congenital heart disease. 3. Hepatic or renal dysfunction. 4. Neurological or developmental disorders affecting postoperative assessment. 5. Chronic use of sedatives, opioids. 6. Emergency surgical procedures. 7. Severe respiratory disease. 8. Incomplete pharmacokinetic sampling. Statistical Analysis: Data were entered into Microsoft Excel and analyzed using SPSS version 26.0. Categorical variables were shown as frequencies and percentages, whilst continuous variables were shown as mean ± standard deviation (SD). It was deemed statistically significant if the p-value was less than 0.05. When compared to the control group, patients given dexmedetomidine had fewer anaesthetic needs, lower scores for postoperative pain, less emergence agitation, and better recovery characteristics.

RESULTS

A total of 40 pediatric patients completed the study, with 20 patients in the Dexmedetomidine Group (Group D) and 20 patients in the Control Group (Group C). There was little difference in the groups' demographics and surgical profiles. Administering dexmedetomidine had positive effects on pharmacokinetics, intraoperative haemodynamic stability, anaesthetic requirements, postoperative pain scores, and the occurrence of emerging agitation.

 

Table 1: Baseline Demographic and Clinical Characteristics of the Study Population

Parameter

Group D (n = 20)

Group C (n = 20)

p-value

Age (years, Mean ± SD)

6.7 ± 2.8

6.9 ± 3.0

0.82

Weight (kg, Mean ± SD)

22.4 ± 6.1

23.1 ± 5.8

0.71

Male, n (%)

12 (60.0)

11 (55.0)

0.75

Female, n (%)

8 (40.0)

9 (45.0)

0.75

Duration of Surgery (min)

78.5 ± 16.4

80.2 ± 15.8

0.73

 

Table 1 displays the participants' demographic and clinical information at the beginning of the trial. In terms of age, weight, gender distribution, and length of operation, there were no statistically significant differences between the two groups, suggesting that both were similar prior to intervention.

 

Table 2: Pharmacokinetic Parameters of Dexmedetomidine in Group D

Pharmacokinetic Parameter

Mean ± SD

Peak Plasma Concentration (Cmax, ng/mL)

0.78 ± 0.14

Time to Peak Concentration (Tmax, h)

0.42 ± 0.08

Elimination Half-life (t½, h)

1.90 ± 0.50

Clearance (CL, L/kg/h)

0.82 ± 0.18

Volume of Distribution (Vd, L/kg)

2.30 ± 0.60

 

Table 2 provides a concise overview of dexmedetomidine's pharmacokinetic characteristics. The drug's elimination characteristics were predictable, its distribution volume was moderate, and it reached peak plasma concentration quickly. Results like this point to a good systemic availability and appropriate pharmacokinetic behaviour for usage during surgical procedures in children.

 

Table 3: Comparison of Intraoperative and Postoperative Clinical Outcomes

Parameter

Group D (n = 20)

Group C (n = 20)

p-value

Mean Intraoperative HR (beats/min)

92.4 ± 8.5

104.8 ± 10.7

<0.001

Mean Arterial Pressure (mmHg)

68.7 ± 6.2

76.4 ± 7.1

0.002

Sevoflurane Requirement (%)

1.6 ± 0.3

2.1 ± 0.4

<0.001

FLACC Pain Score at 4 h

2.1 ± 0.9

4.3 ± 1.2

<0.001

FLACC Pain Score at 12 h

2.8 ± 1.0

4.1 ± 1.4

0.003

Time to First Rescue Analgesia (h)

8.6 ± 2.1

4.7 ± 1.8

<0.001

 

The effectiveness of dexmedetomidine in clinical practice is seen in Table 3. Patients who were given dexmedetomidine had far better haemodynamic stability, needed less anaesthetic, reported less pain after surgery, and needed rescue analgesia for a longer period of time. The results show that the anaesthetic and perioperative analgesia were improved.

 

Table 4: Recovery Characteristics and Adverse Events

Parameter

Group D (n = 20)

Group C (n = 20)

p-value

Emergence Agitation, n (%)

2 (10.0)

8 (40.0)

0.028

Rescue Analgesic Requirement, n (%)

5 (25.0)

14 (70.0)

0.005

Nausea/Vomiting, n (%)

2 (10.0)

6 (30.0)

0.12

Bradycardia, n (%)

2 (10.0)

0 (0.0)

0.14

Hypotension, n (%)

1 (5.0)

0 (0.0)

0.31

Respiratory Depression, n (%)

0 (0.0)

0 (0.0)

 

Table 4 displays the features of postoperative healing as well as adverse occurrences. The group given dexmedetomidine had far less emergency agitation and needed rescue analgesics. It was determined that intervention was not necessary in the few patients who experienced mild bradycardia and hypotension while using dexmedetomidine. Neither group reported any instances of respiratory depression.

DISCUSSION

This research aimed to determine how well dexmedetomidine worked as a supplement to general anaesthesia for children having elective surgeries, as well as its pharmacokinetics and clinical effectiveness. Without major side effects, the results showed that dexmedetomidine had good pharmacokinetic properties, increased intraoperative haemodynamic stability, decreased anaesthetic needs, improved postoperative analgesia, and decreased emergence agitation. These findings lend credence to dexmedetomidine's rising profile as an effective adjuvant in paediatric anaesthesia [14, 15]. This investigation ensured that differences in outcomes were mainly due to the administration of dexmedetomidine since the demographic and surgical parameters of both groups were equivalent. With a mean peak plasma concentration (Cmax) of 0.78 ± 0.14 ng/mL, an elimination half-life of 1.90 ± 0.50 hours, clearance of 0.82 ± 0.18 L/kg/h, and a volume of distribution of 2.30 ± 0.60 L/kg, the medication displayed predictable pharmacokinetic behaviour [16-18]. The present study found that patients who received dexmedetomidine had much better intraoperative haemodynamic stability, which was a key discovery. Compared to the control group, those undergoing surgery had more consistent mean arterial pressure and heart rates. The activity of dexmedetomidine, a sympatholytic, reducing the release of catecholamines and the stress responses caused by anaesthesia and surgical stimulation, is responsible for this effect. Children require haemodynamic stability more than adults because changes in their heart rate and blood pressure might heighten the risk of complications during surgery and make anaesthetic management more difficult [19-21]. Dexmedetomidine significantly reduced the need for inhalational anaesthetics, according to the study. As a result of the drug's anesthetic-sparing effect, the sevoflurane requirement was lowered by about 22%. Prior research has shown that dexmedetomidine improves sedation and analgesia, which in turn decreases the requirement for opioids and volatile anaesthetics. There may be better recovery profiles and less exposure to anesthetic-related side effects if less anaesthetic is used [22, 23]. Dexmedetomidine has a favourable safety profile in this investigation. Medications were not necessary for the brief episodes of mild bradycardia and hypotension that occurred in a few participants. Notably, there were no instances of respiratory depression. For paediatric patients, dexmedetomidine is an ideal alternative to opioids and other sedatives because it reduces anxiety and pain without significantly impacting breathing. This study's lack of serious respiratory side effects lends credence to its potential safety for everyday clinical use [25]. Previous investigations have shown that dexmedetomidine is an effective adjunct to paediatric anaesthesia, and the results of this study are in line with those findings. According to a plethora of research, this medication lessens the need for opioids and anaesthetics, stabilises haemodynamic parameters, and lessens the likelihood of emergence delirium after surgery. In order to better understand the drug's function in paediatric anaesthesia, the current study adds to the existing body of information by integrating pharmacokinetic evaluation with clinical outcome assessment ]26[.

CONCLUSION

Dexmedetomidine had advantageous pharmacokinetic properties and notable therapeutic advantages when administered as an adjunct to general anaesthesia in children. Its application was linked to enhanced intraoperative haemodynamic stability, diminished anaesthetic needs, superior postoperative pain management, extended analgesia, and a reduced occurrence of emerging agitation. The medication had a positive safety profile, characterised by few side effects and an absence of considerable respiratory depression. These results indicate that dexmedetomidine is a secure and efficacious supplement in paediatric anaesthesia, potentially enhancing perioperative results and recovery quality.

 

Funding

None

Conflict of Interest:

None

 

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