Evaluation the effect of ketamine as a prevention of shivering after spinal anesthesia in lower limb orthopedic surgery in 5Azar hospital in 1402(2023)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231002059586N1

Enrollment

Registered

2023-10-23

Start date

2023-11-06

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

The effect of ketamine in the prevention of shivering after spinal anesthesia..

Interventions

Intervention group: Ketamine injection.

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: The age of the study subjects is 18-60 years ASA1, 2 Orthopedic surgery of the lower limb PT-PTT tests are normal The patient must consent to the research.

Exclusion criteria

Exclusion criteria: Patient dissatisfaction with spinal anesthesia ASA 3,4,5 Neurological and psychiatric diseases Myelopathy and peripheral neuropathies Spinal canal stenosis Aortic stenosis Infection High blood pressure is not controlled History of cerebral aneurysms High intracerebral pressure Pregnancy MI in the last 3 months

Design outcomes

Primary

Measure	Time frame
Shivering. Timepoint: The occurrence of shivering is checked in 15, 30, 45, 60, 75 minutes after the spinal procedure. Method of measurement: Based on the patient's clinical symptoms of having or not having shivering, it is done.	—

Secondary

Measure	Time frame
Hemodynamic changes including: Change in mean arterial pressure. Timepoint: It is measured after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: mmHg, number per minute, percent.;Nausea and vomiting. Timepoint: The occurrence of nausea and vomiting after spinal anesthesia is checked in 15, 30, 45, 60, 75 minutes. Method of measurement: It is evaluated based on the occurrence of symptoms of nausea and vomiting.;Change in heart rate. Timepoint: It is checked based on the rate of heart rate change after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: It is measured by the number of heartbeats per minute.;Hallucination: Misunderstanding of objects or events that involve human senses. Visual hallucinations are more common in the use of ketamine. Timepoint: It is checked based on the occurrence of hallucination symptoms after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: Hallucination is evaluated based on having or not having clinical symptoms.	—

Measure

Time frame

Hemodynamic changes including: Change in mean arterial pressure. Timepoint: It is measured after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: mmHg, number per minute, percent.;Nausea and vomiting. Timepoint: The occurrence of nausea and vomiting after spinal anesthesia is checked in 15, 30, 45, 60, 75 minutes. Method of measurement: It is evaluated based on the occurrence of symptoms of nausea and vomiting.;Change in heart rate. Timepoint: It is checked based on the rate of heart rate change after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: It is measured by the number of heartbeats per minute.;Hallucination: Misunderstanding of objects or events that involve human senses. Visual hallucinations are more common in the use of ketamine. Timepoint: It is checked based on the occurrence of hallucination symptoms after spinal anesthesia in 15, 30, 45, 60, 75 minutes. Method of measurement: Hallucination is evaluated based on having or not having clinical symptoms.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactPparvaneh Ebrahimzadeh

Gorgan University of Medical Sciences

dr.parvaneh.ez@gmail.com+98 17 3115 3367

Outcome results

None listed

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