The effect of adding lidocaine to ketamine on hemodynamic parameters

The effect of adding lidocaine to ketamine on hemodynamic parameters during sedation in endoscopy of children 1 to 6 years old

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211108053008N1

Enrollment

120

Registered

2022-02-09

Start date

2022-01-21

Completion date

Unknown

Last updated

2022-03-08

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

Conditions

Condition 1: Diseases of oesophagus, stomach and duodenum. Condition 2: Diseases of oesophagus, stomach and duodenum. Condition 3: Diseases of oesophagus, stomach and duodenum. Condition 4: Diseases of oesophagus, stomach and duodenum. Condition 5: Diseases of oesophagus, stomach and duodenum. Condition 6: Diseases of oesophagus, stomach and duodenum. Condition 7: Diseases of oesophagus, stomach and duodenum. Condition 8: Diseases of oesophagus, stomach and duodenum. Condition 9: Diseases of oes

Interventions

Intervention 1: Intervention group: In this group, two minutes before entering the endoscopy room, they undergo intravenous injection of 1 mg / kg lidocaine with 1 mg / kg ketamine, then went to the e

Eligibility

Sex/Gender

All

Age

1 Years to 6 Years

Inclusion criteria

Inclusion criteria: Children from one to six years old who undergo endoscopy in Imam Hossein Hospital in Isfahan

Exclusion criteria

Exclusion criteria: Symptoms of colds in the last two weeks History of irritable airway disease History of asthma or any airway disease Convulsions High ICP Cardiovascular diseases Central nervous system disease Mental illness porphyria Thyroid disease

Design outcomes

Primary

Measure	Time frame
Heart rate. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Pulse oximeter.;Percentage of oxygen saturation. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Pulse oximeter.;Respiratory rate. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: View and count.;Mean arterial pressure. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Mercury sphygmomanometer.;Systolic arterial pressure. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Mercury sphygmomanometer.;Diastolic arterial pressure. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Mercury sphygmomanometer.;Bradycardia. Timepoint: During the procedure. Method of measurement: Pulse oximeter.;Tachycardia. Timepoint: During the procedure. Method of measurement: Pulse oximeter.	—

Measure

Time frame

Heart rate. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Pulse oximeter.;Percentage of oxygen saturation. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Pulse oximeter.;Respiratory rate. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: View and count.;Mean arterial pressure. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Mercury sphygmomanometer.;Systolic arterial pressure. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Mercury sphygmomanometer.;Diastolic arterial pressure. Timepoint: One minute before the drug injection and every 5 minutes until the end of the procedure in the lidocaine and ketamine group with the ketamine and placebo groups. Method of measurement: Mercury sphygmomanometer.;Bradycardia. Timepoint: During the procedure. Method of measurement: Pulse oximeter.;Tachycardia. Timepoint: During the procedure. Method of measurement: Pulse oximeter.

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Secondary

Measure	Time frame
Duration of stay in recovery. Timepoint: After the procedure. Method of measurement: Modified Aldret Score.;Satisfaction of the doctor performing the endoscopy. Timepoint: During the procedure. Method of measurement: LIKERT.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmir Shafa

Esfahan University of Medical Sciences

amir_shafa@med.mui.ac.ir+98 31 6833 1419

Outcome results

None listed

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