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

Evaluation of the Efficacy of Entonox in Reducing Pain, Anxiety, and Radial Artery Spasm During Trans radial Coronary Angiography

A controlled, parallel-group, single-blind, randomized, phase 3 clinical trial on 118 patients, (two groups of 59 patients). For randomization, in order to prevent disruption of the routine process of the angiography unit and reduce personnel confusion, drug allocation is done on a time-based basis.

Place of performance: Angiography Department, Hajar Hospital, Shahrekord Initially: Providing necessary explanations, measuring and recording the patient's baseline condition before entering the catheter room Patients are subject to standard monitoring throughout the procedure. Before starting the procedure, the patient is fitted with a mask (Entonox gas / oxygen gas) and the procedure begins. At the end of the procedure, Entonox is discontinued and the patient returns to full consciousness within a few minutes. The patient's hand pain level and the patient's anxiety and satisfaction with the entire angiography experience are immediately measured. Blinding method: Single blind (participants will not be aware of the type of intervention received.)

Inclusion criteria: Stable and non-emergency patient Written informed consent Exclusion criteria: Contraindications to Entonox History of reaction to N2O Decreased level of consciousness

In the control group, patients will only be given oxygen continuously at a constant flow rate of 3 to 5 liters per minute through a simple mask. In the intervention group, the mask will contain Entonox, which is delivered to the patient through a standard delivery system equipped with a Valve Demand.

Reduced risk of radial spasm or vasovagal symptoms; Hemodynamic stability; Speed ​​of return to function

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.

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.