A Comparison of Dexmedetomidine and Propofol in sedation efficacy in patients with elective upper gastrointestinal endoscopy

Determine and comparison of Dexmedetomidine and Propofol in sedation efficacy in patients with elective upper gastrointestinal endoscopy

Clinical trial phase3 with 2parallel groups, 3-sided blind, having balanced block randomization with considering gradual patient referral and sample size of 60

After obtaining written consent, patients who refers to Ali ibn Abitalib hospital for upper endoscopy, randomly assigned to 2groups of Dexmedomidine(D) and Propofol(P). Syringe of drugs will coded by an anesthetist who doesn't interfere with patient's sedation and evaluation process; it coded with a three-digit code, and patients divided according to the code for D or P group. Study is 3-sided blind, and patient, endoscopic physician, and person evaluating the symptoms are blinded to type of treatment group, and only a supervisor who prepares drugs and divides patients according to the code for each group, will know the treatment type received by patients.

Enter criteria:patients with elective upper gastrointestinal endoscopy with ASA class ≤3 Not-enter criteria:Having cardiovascular-liver- kidney- psychiatric disease, SBP<90, Drug Addiction, Egg and soy allergy, Emergency endoscopy

In D group, Dexmedetomidine doses of 0.5μg/kg bolus and 0.7-0.5μg/Kg/hr infusion and in P group ,Propofol with doses of 0.5mg/kg bolus and 30μg/Kg/min infusion will given intravenously to patients. Patient hemodynamics will be checked and monitored from start of medication. Relaxation after taking drugs will asked using Ramsay Relaxation Scale from 0-5 (0-Restless,1-Relax,2-Sleepy,3-Confuse but Responded to Verbal Orders,4-No Response to Verbal orders,5-No Response to painful incitements) and will evaluated by an anesthesiologist. After patient becomes alert, sedation satisfaction will be asked.

Sedation

After obtaining written consent, patients who are elective for upper endoscopy are randomly assigned to two groups that are prescribed to a group of Dexmedomidine (D) and group of Propofol (P). The syringe of drugs will coded by an anesthetist who does not interfere with the patient's sedation and evaluation process; it coded with a three-digit code, and the patients are divided according to the code for the Dexmedomidine or Propofol group. The study is three-sided blind, and the patient, the endoscopic physician, and the person evaluating the symptoms are blind to the type of treatment group, and only a supervisor who prepares the drugs, and divides patients according to the code for each groups will know the type of treatment received by the patient.

Only a portion of the information, such as the original outcome information, will be shared.

6 months after printing the results

Data will only be available to researchers working in academic institutions.

Data should only be used to get ideas in future research.

Referring to the university's research deputy

After the registering of request in Research deputy and passing the routine office process, documents will be available up to maximum of one week.