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Studying the effect of diphenhydramine on clinical outcomes of cardiac surgery.

The Effect of using Diphenhydramine During Anesthesia Induction on Clinical Outcomes After Coronary Artery Bypass GraftingSurgery (CABG)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250911067212N1
Enrollment
100
Registered
2026-02-02
Start date
2025-09-22
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Coronary artery disease. Ischaemic heart diseases

Interventions

Intervention 1: In the intervention group, 1 mg/kg diphenhydramine will be administered intravenously. The following drugs will be used for anesthesia: 1-2 mg/kg propofol, 6-8 µg/kg fentanyl, 0.05-0.0

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: Adult patients (aged 18-80 years) Patients with American Society of Anesthesiologists (ASA) physical status I-III Patients who have informed consent to participate in the study Patients admitted to Tehran Heart Center Hospital

Exclusion criteria

Exclusion criteria: Patients with known hypersensitivity to diphenhydramine or other antihistamines Pregnant or breastfeeding women Patients with significant hepatic or renal dysfunction. Patients on medications that may interact with diphenhydramine (e.g., monoamine oxidase inhibitors)

Design outcomes

Primary

MeasureTime frame
Normal and acceptable values ??are systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg. Timepoint: Patients' blood pressure is recorded at 20 and 60 minutes of surgery. Blood pressure is also measured and recorded at 1, 5, 12, and 24 hours after surgery. Method of measurement: Blood pressure is measured using an arteriole, which is fixed to the patient before the procedure.;Heart rate, the normal range of which is 60 to 100 beats per minute. Timepoint: Blood pressure is recorded at 20 and 60 minutes of surgery. Blood pressure is measured and recorded at 1, 5, 12, and 24 hours after surgery. Method of measurement: It is measured by the section monitoring device.;Oxygen saturation level (SpO2), the standard range is between 94 and 99 percent. Timepoint: It is measured and recorded during the 20th and 60th minutes of surgery, as well as at 1, 5, 12, and 24 hours after surgery. Method of measurement: It is measured with a pulse oximetry device.;Normal values ??for the bispectral index (BIS) are 40 to 60. Timepoint: Once immediately after the injection of anesthetic maintenance drugs. Method of measurement: With a dual-spectrum index measuring device in the operating room.

Secondary

MeasureTime frame
The duration of hospitalization. Timepoint: 3 to 4 days after surgery. Method of measurement: Check the discharge order by the attending physician.

Countries

Iran (Islamic Republic of)

Contacts

Public Contactafzal shamsi

Tehran University of Medical Sciences

alliedmed@tums.ac.ir+98 21 8898 3025

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026