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To study ability of two drugs fentanyl and midazolam in decreasing occurrence of muscle movement caused by etomidate (a drug used to put patient to sleep in anesthesia)

Effect of pretreatment with a combination of fentanyl and midazolam for prevention of etomidate induced myoclonus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/09/007324
Enrollment
210
Registered
2016-09-29
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: G978- Other intraoperative and postprocedural complications and disorders of nervous system

Interventions

Intervention1: Fentanyl plus midazolam combination: Fentanyl plus midazolam combination will be given before etomidate administration Control Intervention1: Fentanyl Midazolam: Fentanyl will be given

Sponsors

Safdarjang Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: American Society of Anesthesiology physical status I and II adult patients Elective surgery requiring general anesthesia

Exclusion criteria

Exclusion criteria: Patients with allergy to benzodiazepines, opioids or etomidate, with neuropsychological illness, seizure disorder, sepsis, history of alcohol or drug abuse and those who have received analgesics or sedatives within the previous 24h;Patients on steroid medication, or those who have received steroids in the last 3 months and those with adrenocortical insufficiency; anticipated duration of surgery less than 30 minutes.

Design outcomes

Primary

MeasureTime frame
To compare the effect of pre-treatment with combination of midazolam and fentanyl with either drug used alone on the incidence and severity of etomidate induced myoclonus in adult patients undergoing elective surgery under general anesthesiaTimepoint: One minute after administration of etomidate

Secondary

MeasureTime frame
1. To study the effect of pretreatment with midazolam, fentanyl and their combination on haemodynamic parameters. 2. To study the effect of pretreatment with midazolam, fentanyl and their combination on degree of sedation Timepoint: Haemodynamic parameters: Baseline, preinduction, postinduction,at 3 min post-induction, and at 1 min, 3 min and 5 min after intubation. Sedation: After 5 minutes of administration of study drugs (fentanyl and midazolam)

Countries

India

Contacts

Public ContactSmita Prakash

Vardhman Mahavir Medical College and Safdarjang Hospital, New Delhi, India

drsunilprakash@gmail.com09810347125

Outcome results

None listed

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