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Comparative Study on the Effectiveness of Sedative Drugs in Controlling Pain and Anxiety during Intracardiac Electronic Device Implantation between Patients Receiving the Protocol 1 Hour Prior to EP Lab Entry and Those Receiving It Inside the EP Lab

Comparative Study on the Effectiveness of Sedative Drugs in Controlling Pain and Anxiety during Intracardiac Electronic Device Implantation between Patients Receiving the Protocol 1 Hour Prior to EP Lab Entry and Those Receiving It Inside the EP Lab

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250325065157N1
Enrollment
88
Registered
2025-05-01
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Cardiac disease that needs the implantation of cardiac devices.

Interventions

Intervention 1: Intervention Group 1: The drugs included Morphine sulfate 0.05 mg per kilogram of body weight, administered slowly via injection. If the patient was over 70 years old or had COPD, the
if the patient is over 70 years old or has COPD, the received dose is halved. Additionally, Andanestron 4 mg—equivalent to one ampoule in 100 cc of normal saline—and Apotel 1 g—equivalent to one ampou

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Cardiac patients older than 18 years old that need to implantation of cardiac devices

Exclusion criteria

Exclusion criteria: Lack of patient consent Lack of communication skills Under 18 years old Comorbid psychological disorder

Design outcomes

Primary

MeasureTime frame
Pain and anxiety. Timepoint: Before and after the procedure. Method of measurement: Pain was assessed using the VAS questionnaire, and anxiety was assessed using the Beck questionnaire.

Secondary

MeasureTime frame
Complications during the procedure. Timepoint: After procedure. Method of measurement: Pneumothorax was assessed using CXR (Chest X-ray), and hematoma was assessed through clinical examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAida zeinali

Tehran University of Medical Sciences

Aida_23z@yahoo.com+98 21 2225 0634

Outcome results

None listed

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