Effect of sedation by propofol and midazolam on cognitive performance

Comparison of the effect of sedation by Propofol and Midazolam on cognitive performance in patients older than 65 years candidate for Hip surgery undergoing spinal anesthesia: double blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120915010841N19

Enrollment

136

Registered

2019-07-01

Start date

2019-02-21

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

Cognitive disorders following hip surgery under spinal anesthesia. Senile degeneration of brain, not elsewhere classified

Interventions

Intervention 1: First Intervention group : The amount of 0.2 mg/kg Propofol 1%(10mg/ml and made by B.BRAUN company in Germany), is injected intravenously after spinal anesthesia by anesthesiologist. I

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients older than 65 years Patients with ASA class 1 and 2 Patients candidate for hip surgery undergoing spinal anesthesia

Exclusion criteria

Exclusion criteria: Failure to spinal anesthesia and general anesthesia Patients with history of alcohol and drug use, sedation and anticonvulsants History sensitivity to anesthetic drugs History of cognitive impairment Spinal anesthesia contraindications

Design outcomes

Primary

Measure	Time frame
The percentage of people who have Mini Mental State Examination scores less than 20 after spinal anesthesia and taking Propofol or Midazolam. Timepoint: The day before surgery and before discharging from the hospital. Method of measurement: Using Mini Mental State Examination questionnaire.	—

Secondary

Measure	Time frame
Nausea & vomiting. Timepoint: After surgery. Method of measurement: Observation.;Systolic and Diastolic Blood Pressure. Timepoint: Every three minutes to 20 minutes and then every 10 minutes until the end of the surgery. Method of measurement: Non-invasive automatic barometric device.;Heart Rate. Timepoint: Every three minutes to 20 minutes and then every 10 minutes until the end of the surgery. Method of measurement: Using a pulse oximeter.	—

Measure

Time frame

Nausea & vomiting. Timepoint: After surgery. Method of measurement: Observation.;Systolic and Diastolic Blood Pressure. Timepoint: Every three minutes to 20 minutes and then every 10 minutes until the end of the surgery. Method of measurement: Non-invasive automatic barometric device.;Heart Rate. Timepoint: Every three minutes to 20 minutes and then every 10 minutes until the end of the surgery. Method of measurement: Using a pulse oximeter.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNahid Manouchehrian

Hamedan University of Medical Sciences

manuchehriann@gmail.com+98 81 3827 7012

Outcome results

None listed

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