Comparison of sedative efficacy of propofol-ketamine versus propofol-ketamin plus lidocaine spray outside the operating room

Phase 2

Recruiting

Conditions: Sedation management of patients referred for Endoscopy and reduce their anxiety.

Registration Number: IRCT20201027049160N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 154

Inclusion Criteria

Candidate patients for endoscopy who require anesthesia
In the age range of 18 to 65 years old
Classification of Group 1 American Society of Anesthesiologists (ASA Class I) are selected as inclusion criteria

Exclusion Criteria

the patient's unwillingness to participate in the study
Age less than 18 years or more than 65 years
They have cardiovascular disease
They have kidney failure or liver failure
They are addicted
Contraindicated propofol ketamine or lidocaine spray
Esophageal or gastric perforation during the procedure
Esophageal or gastric bleeding during the procedure
Changing the type of procedure during endoscopy or the need for surgery

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A score of 5 or 6 Ramsay criteria in the questionnaire. Ramsay sedation criteria including 6 scores is as follows: 1. Completely awake and anxious 2. Quiet and calm with enough cooperation 3. Asleep and wakes up with a verbal command 4. Asleep and woke up with mild stimulation, but gives a strong reaction to painful stimuli 5. Slow reaction to painful stimuli 6. Lack of reaction to painful stimulition. Timepoint: 5 minutes after the procedure, 10 minutes after the procedure, 15 minutes after the procedure. Method of measurement: Verbal measurement criteria.

Secondary Outcome Measures

Name	Time	Method
Recovery time. Timepoint: Recovery time is defined as fast (less than 5 minutes), medium (between 5 to 10 minutes) and slow (more than 15 minutes). Method of measurement: Patient's appropriate answers to questions.;Nausa and vomiting of patients based on visual analogue score from the end of the procedure until the time of recovery will be recorded. Timepoint: Every 5 minutes. Method of measurement: It is expressed by the person herself/himself.;Blood pressure. Timepoint: Every 5 minutes. Method of measurement: Blood pressure monitor.;Heart beat. Timepoint: Every 5 minute. Method of measurement: Cardaic monitor.;Arterial blood oxygen saturation. Timepoint: Every 5 minutes. Method of measurement: Respiratory monitor.