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Comparison of the effects of melatonin and gabapentin on shivering after knee surgery with spinal anesthesia

Comparison of two drugs melatonin and gabapentin on shivering after knee surgery with spinal anesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110103005536N13
Enrollment
100
Registered
2025-09-09
Start date
2025-10-21
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Shivering after surgery.

Interventions

Intervention 1: Intervention group: For group A, melatonin is administered as a single dose of 5 mg orally with 50 cc of water one hour before the operation. Then, after entering the operating room, f

Sponsors

Army University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 60 Years

Inclusion criteria

Inclusion criteria: All patients that are 20-60 years old Patients with (II, I) ASA No history of taking antidepressants with catecholamine or serotonin reuptake mechanisms (15, 16, 18) Completion of informed consent by the patient (after full explanation about the safety and health of the various stages of the plan and obtaining informed consent)

Exclusion criteria

Exclusion criteria: Infusion of blood and its cold products during surgery Patient or project manager's awareness of the type of medication prescribed Dissatisfaction of the patient or companions for any reason during the implementation of the plan

Design outcomes

Primary

MeasureTime frame
Shivering. Timepoint: Immediately after surgery until discharge from recovery. Method of measurement: According to the four criteria for grading postoperative tremor (table 1 mentioned in the proposal).;Nausea and vomiting. Timepoint: Immediately after surgery until discharge from recovery. Method of measurement: By observing and assessing clinical symptoms and asking the patient questions.;Sedation. Timepoint: Immediately after surgery until discharge from recovery. Method of measurement: Any and all degrees of unresponsiveness to auditory and tactile stimuli According to the table grading of sedation(Table 2 mentioned in the proposal).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohamadreza Rafiei

Artesh University of Medical Sciences

mo_rafiei@armyums.ac.ir+98 21 8802 8933

Outcome results

None listed

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