Comparison of hemodynamic effects (blood pressure and heart rate) of propofol and fentanyl administration with sodium thiopental and fentanyl in intrathecal chemotherapy of children with acute lymphocytic leukemia.

Comparison of the hemodynamic complications (Blood Pressure and Heart Rate) of propofol and Fentanyl with thiopental sodium and Fentanyl administration in intrathecal chemotherapy of children aged2 to 15 years with Acute lymphoblastic leukemia: a randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20240923063126N1

Enrollment

152

Registered

2024-09-30

Start date

2024-10-06

Completion date

Unknown

Last updated

2025-01-08

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

Conditions

Acute lymphoblastic leukemia. Acute lymphoblastic leukemia [ALL]

Interventions

Intervention 1: Intervention group: propofol at a dose of 2.5 kg/body weight along with fentanyl at a dose of 1 microgram/body weight during 30 seconds intravenous injection. Intervention 2: Control g

Eligibility

Sex/Gender

All

Age

2 Years to 15 Years

Inclusion criteria

Inclusion criteria: The American Society of Anesthesiologists (ASA) class I&II (Grade 1: No cardiovascular, respiratory, glandular and Grade 2: Controlled diabetes) Children with acute lymphocytic leukemia and need intrathecal chemotherapy Age 2 to 15 years

Exclusion criteria

Exclusion criteria: Coagulation problems Existence of chronic heart and lung disease Existence of chronic liver disease Allergy to certain food Seizure history

Design outcomes

Primary

Measure	Time frame
Blood pressure. Timepoint: At the beginning of the study, one, five and ten minutes after the complete recovery of the patient. Method of measurement: Mercury sphygmomanometer.;Heart Rate. Timepoint: At the beginning of the study, one, five and ten minutes after the complete recovery of the patient. Method of measurement: Direct counting of the patient's pulse.	—

Secondary

Measure	Time frame
Intensity of pain. Timepoint: At the beginning of the study, minutes 15 and 30 and after recovery. Method of measurement: Pain intensity was measured by observing the intensity of restlessness, facial changes, squeezing hands and feet and asking the patient visually (Visual Analog Scale: VAS).;The presence of nausea and vomiting. Timepoint: At the beginning of the study, one hour and three hours after the complete recovery of the patient. Method of measurement: Measuring the presence of nausea and vomiting by observation.	—

Measure

Time frame

Intensity of pain. Timepoint: At the beginning of the study, minutes 15 and 30 and after recovery. Method of measurement: Pain intensity was measured by observing the intensity of restlessness, facial changes, squeezing hands and feet and asking the patient visually (Visual Analog Scale: VAS).;The presence of nausea and vomiting. Timepoint: At the beginning of the study, one hour and three hours after the complete recovery of the patient. Method of measurement: Measuring the presence of nausea and vomiting by observation.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactNaghmeh Nikzad

Babol University of Medical Sciences

n.nikzad@mubabol.ac.ir+98 11 3235 4951

Outcome results

None listed

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