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IRCT20201028049181N5 IRCT 2026-08-24 Shahre-kord University of Medical Sciences Evaluation of the Efficacy of Entonox in Reducing Pain, Anxiety, and Radial Artery Spasm During Trans radial Coronary Angiography Evaluation of the Efficacy of Entonox in Reducing Pain, Anxiety, and Radial Artery Spasm During Trans radial Coronary Angiography: A Randomized Controlled, single-blind study 2026-09-23 anticipated 118 Recruiting https://irct.ir/trial/92691 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To avoid disruption to the routine of the angiography unit and to reduce staff confusion, drug allocation is time-based; on pre-determined days, all eligible patients receive a specific drug (for example, patients on Sunday receive a simple oxygen mask and patients on Tuesday receive an Entonox mask). This allocation is fixed for the entire study period and the proportion of patients in the two groups is considered equal in terms of the number of sessions, Blinding description: In this study, in order to reduce bias, a single-blind blinding method will be used. In this way, participants will not be aware of the type of intervention they will receive (Entonox gas/oxygen gas), while the researchers will be aware of the allocation of individuals to different groups. The allocation of samples to groups will be done randomly and the interventions will be presented in such a way that they will not be distinguishable to the participants in terms of appearance and method of consumption. This method is used to reduce psychological effects and participant response bias and increase the validity of the study results. 3 Trans-radial angiograohy. Intervention 1: Control group: The mask contains only simple oxygen, and the patient would have no way of knowing what type of gas was being inhaled, given the lack of a specific odor. Intervention 2: Intervention group: The mask contains a pre-mixed, fixed 50:50 Entonox mixture, which is delivered to the patient via a standard delivery system equipped with a Demand Valve. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Pedram Babaee
Unit 7, 1st Block (Right Side), Asatid Residential Complex, Shahrekord University of Medical Sciences Central Headquarters, Kashani St., Shahrekord
Shahrekord Iran (Islamic Republic of) 8365788157 +98 38 3222 5505 Pedram.babaee70@gmail.com Shahre-kord University of Medical Sciences scientific Pedram Babaee
Unit 7, 1st Block (Right Side), Asatid Residential Complex, Shahrekord University of Medical Sciences Central Headquarters, Kashani St., Shahrekord
Shahrekord Iran (Islamic Republic of) 8365788157 +98 38 3222 5505 Pedram.babaee70@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Age 18 to 80 years Stable, non-emergency patient ASA Class I to III Possibility of using the Entonox mouthpiece or mask Patients who are candidates for elective angiography Written informed consent 18 years 80 years Both Contraindications for Entonox (pneumothorax, intestinal obstruction, air embolism, ocular gas injection, increased ICP) Severe COPD Severe CHF History of reaction to NO Inability to cooperate or consume properly Decreased level of consciousness High pulmonary pressure Drug sensitivity I73 Other peripheral vascular diseases Placebo Treatment - Drugs Control group: The mask contains only simple oxygen, and the patient would have no way of knowing what type of gas was being inhaled, given the lack of a specific odor. Intervention group: The mask contains a pre-mixed, fixed 50:50 Entonox mixture, which is delivered to the patient via a standard delivery system equipped with a Demand Valve. Patient pain score. Timepoint: Immediately after the procedure is completed and the patient is fully conscious. Method of measurement: Visual Analogue Scale 0 -10. Patient anxiety score throughout the procedure. Timepoint: Immediately after the procedure is completed and the patient is fully conscious. Method of measurement: Short Spielberger Inventory (6-STAI). Severity of spasm. Timepoint: During angiography. Method of measurement: Based on the standard definition 0 to 4(rathore score). Vasovagal. Timepoint: During angiograohy. Method of measurement: Diagnosis based on physician's opinion. Shahre-kord University of Medical Sciences Approved 2026-08-08 Ethics committee of Shahrekord University of Medical Sciences Hajar Hospital, University Headquarters, Parastar St., Kashani Blvd. Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)