Specify the effect of intranasal and intravenous remifentanil on hemodynamic changes after induction and tracheal intubation and comparing with control group

Specify the effect of intranasal and intravenous remifentanyl on hemodynamic changes after induction and tracheal intubation and comparing with control group

Clinical trial with control group with parallel and three-blind side randomized phases of Phase 2 on 180 patients. Random allocation method has been used for randomization.

Research on GA has been conducted using a 3-side blind method for participants who adjust the dose of the drug and injectors and people involved in collecting information and analyzers.

Criteria for entering the study patients with ASA1.2 with ages between 18 and 65 . Conditions for not entering the age of less than 18 or more than 65 ; drug addiction ; Allergy to the drug under study; ASA3,4 patients with severe heart and lung disorders; change anesthesia technique as needed; Severe bleeding and hemodynamic shock and the need to inject blood products and patients who are in the 3rd and 4th grade of kermek Liehan.

1. Average systolic and diastolic arterial BP and HR at baseline times 1-3 minutes after anesthesia just before laryngoscopy at times 1-3-5-10 min after laryngoscopy 2. Complications of IV fentanyl and nasal on bradycardia (pulse less than 60) tachycardia (pulse greater than 100) hypotension (systolic pressure less than 90) Hypertension (systolic pressure greater than 140 and diastolic pressure greater than 90) 3. satisfaction score based on VAS criteria and its division into3 levels: low (0 to 3 points), medium (4 to 6) and high (7 to 10) after surgery. 4. O2 sat and capnography at baseline;1 to 3 min after anesthesia; just before laryngoscopy and at 1-3-5-10 min after laryngoscopy.

The effect of the drug on hemodynamic changes including blood pressure and heart rate;Laryngoscopic duration;Satisfaction ofsurgeon and patient;ABG ;VBG

How to randomize in this study is done by simple randomization method using random allocation software which is an individual randomization unit and random sequencing using this software and based on the order provided to patients. For allocation concealment, the sequentially numbered ,sealed ,opaque envelopes or SNOSE method was used.

The first person divides by simple non-random method / random allocation software into three groups with a total of 60 people.The second person in the treatment encodes 3 groups of intranasal and intravenous drugs and the same amount of normal saline volume. The other person also collects the information of each group without knowing the study group.Data analysis is also performed without the knowledge of the groups.

After completing the study, all the documents can be shared after identifying the participants in the study.

The time period for accessing the study data is December 30, 2020

Data and other study documents will be available only to researchers working in academic and scientific institutions

Other researchers of research centers are provided with a letter of introduction from a reputable center and mention the goals ahead and the type of targeted analysis , if appropriate, information and study data can be reached.

By presenting a valid letter of introduction based on the priority of scientific study organizations and referring to Dr. Mohammad Reza Safavi to the address of Isfahan Al-Zahra Hospital Boulevard and e-mail address: safavi@med.mui.ac.ir

After submitting the request to the responsible person in charge of the study, if it is approved by the research deputy of Isfahan University of Medical Sciences and the approval of the anesthesia department, the research documents will be provided to the person.