Evaluation of sedation depth and anesthetic drug (propofol) requirement in patients undergoing upper gastrointestinal endoscopy with or without oral melatonin premedication. This study focuses on sedation-related physiological responses during a diagnostic procedure, not on a specific disease.. Encounter for other specified special examinations
Conditions
Interventions
Intervention 1: Intervention group: Patients in the intervention group receive 3 milligrams of oral melatonin in capsule form, produced by the Faculty of Pharmacy of Mazandaran University of Medical S
Sponsors
Mazandaran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
15 Years to 55 Years
Inclusion criteria
Inclusion criteria: Age 15–55 ASA class I or II Non-emergency endoscopy BMI between 19–29 No narcotic use in the past week No thyroid, neuromuscular, renal, or psychiatric disease No addiction Not participating in another study Informed consent
Exclusion criteria
Exclusion criteria: Patients with underlying conditions making sedation harmful Benzodiazepine use within past 72 hours Withdrawal from study by patient request
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The total dose of intravenous propofol administered to induce adequate sedation during upper gastrointestinal endoscopy.This variable is the main outcome used to assess the effect of oral melatonin premedication on anesthetic drug requirement. Timepoint: Immediately during the induction of anesthesia before endoscopy, until the patient reaches an adequate level of sedation. Method of measurement: The total dose of propofol administered is recorded in milligrams based on anesthesia records and the propofol vial labeling, measured by the attending anesthesiologist. | — |
Secondary
| Measure | Time frame |
|---|---|
| Level of consciousness (orientation score) of the patient after endoscopy.This outcome evaluates whether oral melatonin affects the patient's recovery awareness after sedation. Timepoint: Before endoscopy, immediately after endoscopy, and every 15 minutes in the recovery room until the patient reaches full consciousness. Method of measurement: The orientation score is assessed using a structured clinical scale: score of 0 for no awareness, 1 for orientation to place, and 2 for orientation to time and place, recorded by the anesthesiologist.;Mean arterial blood pressure (MAP) during and after endoscopy.This variable assesses hemodynamic stability influenced by melatonin premedication. Timepoint: Before propofol injection, every 10 minutes during endoscopy, and every 15 minutes in the recovery room. Method of measurement: Measured using a non-invasive digital blood pressure monitor and documented in the anesthesia record.;Heart rate of the patient during and after endoscopy.This variable helps to assess cardiovascular response to sedation and melatonin premedication. Timepoint: Before propofol injection, every 10 minutes during endoscopy, and every 15 minutes in the recovery room. Method of measurement: Heart rate is continuously monitored using a multi-parameter cardiac monitor and recorded manually by the anesthesiologist.;Arterial blood oxygen saturation (SaO2) during and after endoscopy.This measures the patient's respiratory stability under sedation. Timepoint: Before propofol injection, every 10 minutes during endoscopy, and every 15 minutes in the recovery room. Method of measurement: Measured using a fingertip pulse oximeter integrated into the monitoring system.;Level of sedation (sedation score) during and after endoscopy.This outcome assesses the depth of sedation achieved with melatonin and propofol combination. Timepoint: Before propofol injection, during endoscopy at 10-minute intervals, and every 15 minutes in the recovery room. Method of measurement: A | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSamira Sobhani
Mazandaran University of Medical Sciences
Outcome results
None listed