Comparing the effects of two anesthesia maintenance regime on hemodynamic parameters during anesthesia and postoperative complications

Comparing the effects of Propofol and Propofol-Ketamine anesthesia maintenance regime on hemodynamic parameters during anesthesia and postoperative complications in patients undergoing leg fracture surgery

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015062222867N1

Enrollment

Registered

2016-09-10

Start date

2015-08-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Leg fracture. Fractures of other parts of lower leg

Interventions

Intervention 1: First group: Induction 2mg/kg of Propofol, 5µg/kg of Fentanyl, and 0.5 µg/kg of Atracurium and maintenance regime 100 µg/kg/min Propofol. Intervention 2: Second group:Induction 2mg/kg

Treatment - Drugs

First group: Induction 2mg/kg of Propofol, 5µg/kg of Fentanyl, and 0.5 µg/kg of Atracurium and maintenance regime 100 µg/kg/min Propofol

Second group:Induction 2mg/kg of Propofol, 5µg/kg of Fentanyl, and 0.5 µg/kg of Atracurium and maintenance regime 50 µg/kg/min of Propofol + 25 µg/kg/min Ketamine

Eligibility

Sex/Gender

All

Age

15 Years to 45 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria:Patients between 15-45 years old; Class 1 and 2 ASA; Candidate for leg fracture surgery. Exclusion criteria:History of recent upper respiratory tract infection; Asthma; Allergy (to Propofol-Ketamine, eggs, and soya);Taking antipsychotic drugs; Neuromuscular diseases ; Epilepsy; Acid reflux; Hiatal hernia; Severe anemia; Severe liver diseases; Severe heart diseases; Severe lung diseases; Drugs addiction; A history of motion disease; Migraine

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Heart Rate. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.;Systolic blood pressure. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.;Diastolic blood pressure. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.;Mean arterial pressure. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.	—

Measure

Time frame

Heart Rate. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.;Systolic blood pressure. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.;Diastolic blood pressure. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.;Mean arterial pressure. Timepoint: Before induction, one minute after induction, after laryngoscopy and intubation, and then in 10-minute intervals to the end of the surgery. Method of measurement: Heart monitoring.

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Secondary

Measure	Time frame
Pain. Timepoint: After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals. Method of measurement: Visual Analogue Scale (VAS).;Nausea. Timepoint: After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals. Method of measurement: Visual Analogue Scale (VAS).;Vomiting. Timepoint: After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals. Method of measurement: Visual Analogue Scale (VAS).	—

Measure

Time frame

Pain. Timepoint: After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals. Method of measurement: Visual Analogue Scale (VAS).;Nausea. Timepoint: After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals. Method of measurement: Visual Analogue Scale (VAS).;Vomiting. Timepoint: After anesthesia is finished up to 6 hours after going out of recovery in 2-hour intervals. Method of measurement: Visual Analogue Scale (VAS).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactBibi Fatemeh Shakhs Emampour

Birjand University of Medical Sciences

f.emempour@gmail.com+98 56 3244 3001

Outcome results

None listed

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