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Comparison of the effect of Ketofol with Propofol on patients' vital sign changes during laparotomy

Comparison of the effect of Ketofol (combination of Ketamin and Propofol) with Propofol during anesthesia induction on hemodynamic changes in patients undergo laparotomy

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015021819037N6
Enrollment
90
Registered
2015-03-05
Start date
2014-09-16
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

Condition 1: Heart rate instability due to anesthesia. Condition 2: Blood pressure instability due to anesthesia.

Interventions

Intervention 1: First intervention group (trial): Receiving handmade drug, Ketofol: 10 ml Propofol solution (10 mg/ml, from Fresenius Kabi drug manufacturing company, Germany) with 10 ml Ketamin solut
First intervention group (trial): Receiving handmade drug, Ketofol: 10 ml Propofol solution (10 mg/ml, from Fresenius Kabi drug manufacturing company, Germany) with 10 ml Ketamin solution (50 mg/ml,
Second intervention group (control): Receiving Propofol solution (10 mg/ml, from Fresenius Kabi drug manufacturing company, Germany). One dose of this drug was admitted for the patients intravenously

Sponsors

Investigator
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Patients between 20 to 60 years of age who are candidate for laparotomy (including appendectomy, gastrectomy, cholecystectomy and other kinds of laparotomy) under general anesthesia and are in ASA class 1 (The American Society of Anesthesiologists Physical Status classification system): Normal healthy patients with no organic, physiologic, or psychiatric disturbance. Exclusion criteria: Patients who use cardiac or anti-hypertensive or analgesic or sedative agents, patients who are not NPO (nil per os), diabetic or pregnant patients.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Mean heart rate. Timepoint: In 4 times: before induction, 3, 5 and 10 minutes after induction. Method of measurement: The monitor device.;Mean systolic pressure. Timepoint: In 4 times: before induction, 3, 5 and 10 minutes after induction. Method of measurement: The monitor device.;Mean diastolic pressure. Timepoint: In 4 times: before induction, 3, 5 and 10 minutes after induction. Method of measurement: The monitor device.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Hamid Kayalha

Qazvin University of Medical Sciences

mohammad.kolahdouzha2050@gmail.com+98 28 3333 6004

Outcome results

None listed

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