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Comparison of the effects of intravenous ketamine and intravenous tramadol in the prevalence of shivering after spinal anesthesia

Comparison of the effects of intravenous ketamine and intravenous tramadol in the prevalence of shivering after spinal anesthesia in urological surgeries

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20231021059799N1
Enrollment
90
Registered
2024-04-15
Start date
2024-04-09
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Post Anesthesia Shivering. Other complications of anesthesia

Interventions

Intervention 1: Intervention Group: Patients who immediately receive an intravenous dose of ketamine at a dose of 0.5 mg/kg after spinal anesthesia will be referred to as the ketamine group. Intervent

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age group: 18 to 70 years old Physical status according to ASA classification classes I, II, and III

Exclusion criteria

Exclusion criteria: Patients with contraindications to spinal anesthesia and presence of infection at the site of spinal anesthesia injection, Lack of personal consent, Obesity with BMI > 38 kg/m2, Uncontrolled type 1 and 2 diabetes mellitus, Uncontrolled hypertension history, Moderate to severe valvular heart diseases, Neurological and psychiatric disorders such as stroke, history of brain lesions, obsessive-compulsive disorder, and schizophrenia, Fever exceeding 37.5 degrees Celsius at the beginning of the surgery, Patients with sensitivity to ketamine and its derivatives, Patients with sensitivity to tramadol and its derivatives, History of alcohol consumption, drug abuse, or misuse of sedatives-hypnotics and glucocorticosteroids, Presence of fungal and viral infections, Excessive bleeding, Receipt of blood products, Prolonged surgery duration exceeding three hours, History of recurrent nausea and vomiting following previous urological surgeries, Patients whose operating room drapes become wet during surgery.

Design outcomes

Primary

MeasureTime frame
Shivering after spinal anesthesia in urological surgeries. Timepoint: The severity of patient's shivering will be recorded in the questionnaire every two hours post-operation and at any moment tremor symptoms occur in the patient. Method of measurement: The valid criterion for the grading of shivering is based on the 5-point scoring system of Crossley Mahajan.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSiavash Sangi

Iran University of Medical Sciences

siavashsangi@gmail.com0989189003460

Outcome results

None listed

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