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Comparison of nasal administration of two sedative drugs dexmedetomidine and fentanyl for sedation before surgery in childre

Not Applicable
Conditions
Health Condition 1: null- ASA I/II Patients posted For Elective Surgery
Registration Number
CTRI/2018/04/013050
Lead Sponsor
Bhagat Phool Singh Government Medical College For Women
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Children of American society of Anesthesiologists (ASA) grade I/II/ patients

2.Age group:- 2 to 10 yrs of age of all genders.

3.Weight <= 25kg.

4.Elective surgical procedures under General Anesthesia.

5.Parents and guardian willing to provide their voluntary written informed consent form for participation in the study.

Exclusion Criteria

1.Parents and guardian not willing to participate in the present study.

2.History of allergy and hypersensitivity to dexmedetomidine / fentanyl.

3.Presence of upper respiratory tract infection and nasal pathology.

4.Patients having delayed milestones and who are mentally challenged.

5.Patients with any cardiac/respiratory disease.

6.Surgery lasting for more than 90 minutes will be excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.To determine the time of onset and duration of sedation. <br/ ><br>2.To determine the level of anxiety by child parent separation score. <br/ ><br>3.To determine post-operative sedation and behavior score <br/ ><br>Timepoint: 1.Time of onset and duration of sedation in 45 minutes of premedication and 3 hours of post surgery <br/ ><br>2.Anxiety by child parent separation score at end of 45 minutes of premedication <br/ ><br>3.Post-operative behaviour score at end of surgery <br/ ><br>4.post-operative sedation score at the end of surgery and till 3 hours after surgery <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
1.To determine hemodynamic parameter like heart rate, blood pressure, mean arterial pressure, SpO2 in each group. <br/ ><br>2.To determine the side effect in each group if any. <br/ ><br>Timepoint: In 45 minutes before surgery and intraoperative of maximum 90 minutes
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