A Comparison of Midazolam and Dexmedetomidine as Medication to be given in Nose before Anesthesia in Lower Body Surgeries of Children

Not yet recruiting

• Conditions: Congenital malformations, deformations and chromosomal abnormalities,

• Registration Number: CTRI/2019/06/019711
• Lead Sponsor: Dr Aikta Gupta

Brief Summary

This study is a hospital-based, prospective, comparative, randomized, double-blind study to be conducted atDepartment of Anesthesia, Chacha Nehru Bal Chikitsalaya, New Delhi. The inclusion criteria are children aged 2-10 years undergoing elective infraumbilical surgeries of ASA grade I and II. 70 patients will be allocated in two groups, Group A (receiving intranasal midazolam 0.2 mg/kg) and Group B (intranasal dexmedetomidine 0.5 mcg/kg). The primary outcome measure is preoperative sedation score at the time of shifting into OT and the secondary outcome measure are parental separation score, mask acceptance score, preoperative and intraoperative vital parameters, postoperative emergence (Cravero score) and immediate postoperative sedation score.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-06-16
• Study Start: 2019-06-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Children undergoing infraumbilical surgeries 2.
• ASA grade I and II.

Exclusion Criteria

• Patients having known allergy to the drugs used in study 2.
• Patients having upper respiratory infection 3.
• Patients having neurological disorders 4.
• Patients under treatment with anticonvulsants/sedatives 5.
• Patients spitting out the medication.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preoperative Sedation Score	Prior to administration of study drugs and thereafter every 10 minutes till patients in shifted into operating room

Secondary Outcome Measures

Name	Time	Method
Parental separation score	At the time of shifting into operating room
Mask acceptance score
Preoperative and intraoperative vital parameters
Postoperative emergence (Cravero score)	After completion of surgery and shifting into post anesthesia care unit
Immediate postoperative sedation score	After completion of surgery and shifting into post anesthesia care unit

Trial Locations

Locations (1)

Chahcha Nehru Bal Chikitsalaya; 🇮🇳 East, DELHI, India

Chahcha Nehru Bal Chikitsalaya

🇮🇳East, DELHI, India

Dr Aikta Gupta

Principal investigator

9643308230

aiktab@rediffmail.com