A clinical trial to compare the effects between single dose dexmedetomidine and propofol in soothing children’s uninhibited excitement or emotion on rousing from general anaesthesia following surgical procedures.
Phase 4
- Conditions
- Health Condition 1: 8- Other Procedures
- Registration Number
- CTRI/2023/06/053507
- Lead Sponsor
- Assam Medical College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Children belonging to ASA grade I and grade II,
2.Children undergoing various surgical procedures under general anaesthesia .
Exclusion Criteria
•Parent’s refusal to participate.
•Patients having known allergy to either of study drugs.
•Patients who did not experience ED during the postoperative period.
•Those who developed ED and with the PAED score <15.
•Patients having remarkable history of cardio vascular, metabolic or psychological disorder.
•Patients requiring sedative medication prior to going to the operation theatre.
•Cognitive impairment or communication disorders.
•Patients having difficult airway.
•Patients having medications that effect heart rate or blood pressure.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.The PAED score. <br/ ><br>2.Recovery time.Timepoint: 1.PAED score will be recorded at 5-min intervals (repeated if necessary), <br/ ><br>2. Recovery time will be recorded from arrival in the PACU until the time of spontaneous eye-opening or response to verbal command.
- Secondary Outcome Measures
Name Time Method 1. Incidences of bradycardia and hypotension, if occurs, will be recorded. <br/ ><br>2.Sedation will be assessed using the Stewards simplified postanesthesia recovery score. <br/ ><br>3.Pain will be evaluated using the face, legs, activity, cry, consolability (FLACC) scale. <br/ ><br>4.Other adverse events such as apnea, oxygen desaturation, laryngospasm, nausea, and emesis will also be recorded.Timepoint: 1. Incidences of bradycardia/hyotension- at one min interval, <br/ ><br>2.Sedation (Stewards simplified postanesthesia recovery score) at 5 min intervals. <br/ ><br>3.Pain will be evaluated using (FLACC scale)- at 15, 30 60 and 90 mins <br/ ><br>4. Other adverse events- if occurs.