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

Comparison of the sedative efficacy of propofol-ketamine combination versus propofol-ketamine plus lidocaine spray in outpatient endoscopy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201027049160N1
Enrollment
154
Registered
2020-11-04
Start date
2020-09-22
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention 1: Control group: The group receiving Propofol Ketamin for sedation during Endoscopy. Intervention 2: Intervention group: The group receiving Propofol Ketamin plus Lidocaine spray for sed

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Akhondzade

Ahvaz University of Medical Sciences

Kiamohammadi.sh@ajums.ac.ir+98 61 3391 3455

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026