Investigation of hemodynamic changes of propofol infusion with ketamine infusion for sedation in patients undergoing endoscopy

Comparison Of Hemodynamic Changes Of Infusion Of Propofol with Ketamine For Sedation In Upper Gastrointestinal Endoscopy: A Double Blind Randomized Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250615066195N1

Enrollment

Registered

2025-07-15

Start date

2025-07-23

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

Hemodynamic changes.

Interventions

Intervention 1: The first intervention group: Patients receive a propofol infusion at a rate of 25 micrograms per kilogram of patient weight per minute.Hemodynamic changes, including mean arterial pre

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Grades one and two of the American Society of Anesthesiologists (Grade 1: absence of cardiovascular, respiratory, endocrine problems and Grade 2: controlled diabetes) Age 18-69 years Consent to participate in the study

Exclusion criteria

Exclusion criteria: Neurological and psychiatric diseases Drug addiction and drug dependence History of allergy to egg white Experience perforation and bleeding during endoscopy

Design outcomes

Primary

Measure	Time frame
Heart rate. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: By monitoring device.;Respiratory rate. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: By monitoring device.;Mean arterial blood pressure. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: By monitoring device.;Arterial blood oxygen saturation. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: Pulse oximeter.	—

Measure

Time frame

Heart rate. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: By monitoring device.;Respiratory rate. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: By monitoring device.;Mean arterial blood pressure. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: By monitoring device.;Arterial blood oxygen saturation. Timepoint: It is measured and recorded at time intervals upon arrival, at the beginning and end of the infusion, and at 5, 10, 15, 20, 25, and 30 minutes during the procedure. Method of measurement: Pulse oximeter.

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Secondary

Measure	Time frame
Endoscopist satisfaction. Timepoint: At the end of recovery. Method of measurement: The Visual Analog Scale is evaluated on a scale of 0 to 10, with 10 indicating the highest level of satisfaction and 0 indicating the lowest level of dissatisfaction.;Patient satisfaction. Timepoint: At the end of recovery. Method of measurement: The Visual Analog Scale is evaluated on a scale of 0 to 10, with 10 indicating the highest level of satisfaction and 0 indicating the lowest level of dissatisfaction.;Recovery time. Timepoint: At the end of recovery. Method of measurement: It is determined based on the Aldrete Scale with a score greater than or equal to 9, and the exact time from the time the infusion is stopped until leaving the recovery room will be recorded.;Need for additional propofol dose. Timepoint: At the end of recovery. Method of measurement: Milligram.	—

Measure

Time frame

Endoscopist satisfaction. Timepoint: At the end of recovery. Method of measurement: The Visual Analog Scale is evaluated on a scale of 0 to 10, with 10 indicating the highest level of satisfaction and 0 indicating the lowest level of dissatisfaction.;Patient satisfaction. Timepoint: At the end of recovery. Method of measurement: The Visual Analog Scale is evaluated on a scale of 0 to 10, with 10 indicating the highest level of satisfaction and 0 indicating the lowest level of dissatisfaction.;Recovery time. Timepoint: At the end of recovery. Method of measurement: It is determined based on the Aldrete Scale with a score greater than or equal to 9, and the exact time from the time the infusion is stopped until leaving the recovery room will be recorded.;Need for additional propofol dose. Timepoint: At the end of recovery. Method of measurement: Milligram.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmri Parviz Male

Babol University of Medical Sciences

p.amrimaleh@mubabol.ac.ir+98 11 3223 8301

Outcome results

None listed

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