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Midazolam at end of the surgery - does it prevent emergence agitation?

A prospective randomized double blind placebo controlled study evaluating the efficacy of inj midazolam 0.05 mg/kg for prevention of emergence agitation in children aged 1 - 6 years undergoing general anaesthesia with inhaled sevoflurane.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/09/015790
Enrollment
64
Registered
2018-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R688- Other general symptoms and signs Health Condition 2: H838- Other specified diseases of innerear

Interventions

Intervention1: Inj midazolam: Inj midazolam 0.05 mg /kg 20 minutes prior to the end of the surgery Control Intervention1: Normal saline: 2 cc normal saline

Sponsors

Hinduja National Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: ASA 1 and 2 patients Scheduled for elective surgery of more than 1 hour duration.

Exclusion criteria

Exclusion criteria: ASA 3 and above. Below 1 year and more than 6 years of age Emergency surgery Active Respiratory cardiac disease, neurological disease with delayed mental development

Design outcomes

Primary

MeasureTime frame
To observe and compare the incidence of emergence agitation in test and control groupsTimepoint: At extubation 0 mins, 5min, 10 min, 15 min, 20,30,40,50 and 60 mins—

Secondary

MeasureTime frame
Evaluate and compare the time of emergence Correlation of emergence agitation with pre induction anxiety Osbserve the incidence of requirement of rescue medication To evaluate and compare the duration of stay in recovery room in both groups To correlate the incidence of emergence agitation and postoperative pain To observe the incidence of complicationsTimepoint: In post operative period—

Countries

India

Contacts

Public ContactDr Mohammed aziz ur rehman

P D Hinduja National Hospital and Medical Research Centre

preetidr@hotmail.com9819759754

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026