to compare oral midazolam with dexmedetomidine for sedation given before surgery.

Phase 3

Recruiting

• Conditions: pateints posted for pediatric surgery

• Registration Number: CTRI/2017/09/009943
• Lead Sponsor: Dusu Lalin

Brief Summary

To compare oral dexmedetomidine to oral midazolam for premedication in paediatric patients. To find most optimum dose of dexmedetomidine for oral premedication. 300 patients to be enrolled for study in age group 1 yrs to 7 yrs.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Last Update Posted: 2018-11-24

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• ASA 1 and 2.
• Age 1-7 years.
• Any surgery under general anesthesia.

Exclusion Criteria

• Haemodynamically unstable Mental retardation or neurobehavioral disorders.
• Treatment with sedatives or anticonvulsants.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sedation score after Premedication.	60 minutes after Premedication

Secondary Outcome Measures

Name	Time	Method
Parents seperation anxiety, Mask acceptance on Induction , Anxiety in PACU	1 hour, At induction and In PACU.

Trial Locations

Locations (1)

Indira Gandhi Institute of Medical Sciences,Shiekhpura, Patna, Bihar; 🇮🇳 Patna, BIHAR, India

Indira Gandhi Institute of Medical Sciences,Shiekhpura, Patna, Bihar

🇮🇳Patna, BIHAR, India

Dusu Lalin

Principal investigator

7367967439

dusununlalin@gmail.com