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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05813106
Other study ID # SFH-Dex Peds
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date December 1, 2022
Est. completion date April 30, 2023

Study information

Verified date April 2023
Source Security Forces Hospital
Contact Anwar ul Huda, FRCA
Phone 00966118024331
Email hudaanwar90@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.


Description:

Emergence delirium (ED) is an altered state of consciousness that usually occurs within 45 minutes after cessation of anesthesia. It typically presents as disorientation, averted eyes or staring, psychomotor agitation and non-purposeful, resistive movements like pulling, kicking or flailing (1, 2). ED can result in potential risk of bodily harm to patient or healthcare staffs, prolonged PACU (post-anesthesia care unit) stay and postoperative maladaptive changes including temper tantrums, attention seeking, sleep alterations and bed wetting in children (2). Risk factors for ED include preoperative anxiety and confusion, psychological immaturity and use of various medications peri-operatively (2, 3). The incidence of ED varies by age of patient, anesthesia technique, type of surgeries, pain and also by choice of tool to diagnose ED. It occurs two to three more commonly in children as compared to adults. Scientific literature suggest the incidence of ED in the range between 20 -80 % in pediatric anesthesia practice (4). Various pharmacological interventions in peri-operative period have been used in literature to prevent ED which include use of propofol, fentanyl, ketamine, clonidine, midazolam and dexmedetomidine etc (5). Dexmedetomidine is a potent highly selective alpha-2 agonist. Its effect on the receptors in brain results in sedation resembling non-REM sleep with minimal respiratory depression (6). It has been used as continuous infusion or as fixed dose in the range between 0.15 mcg/kg to 2 mcg/kg to prevent ED in children (7, 8, 9). Higher doses result in better prevention of ED at the expense of more hemodynamic disturbances and longer PACU stay (9) while lower doses were not as effective (7). The aim of this study was to investigate the role of fixed dose of 0.2 mcg/kg dexmedetomidine in prevention of emergence delirium in pediatric patients undergoing general anesthesia.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date April 30, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers No
Gender All
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria: - Patients aged between 2 and 12 years, scheduled to undergo general anesthesia for a surgery with an ASA score of 1 to 3 will be included in the study. Exclusion Criteria: - Parents who refused enrollment or later requested removal for the study, those who are unable to give informed consent and patients with known allergy to dexmedetomidine, psychiatric disorders or use of psychiatric medications will not be included in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine Hydrochloride
Intravenous dexmedetomidine 0.2 mcg/kg
normal saline
normal saline

Locations

Country Name City State
Saudi Arabia Security Forces Hospital Riyadh

Sponsors (1)

Lead Sponsor Collaborator
Security Forces Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Emergence delirium Emergence delirium will be measured using PAED score up to 120 minutes
Secondary Pain score VAS pain score every 15 minutes upto discharge from PACU maximum 120 minutes
Secondary Opioid consumption Morphine equivalent opioid consumption upto discharge from PACU maximum 120 minutes
Secondary Side effects Side effects including PONV, drowsiness PACU stay maximum 120 minutes
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