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Effect of Oral Melatonin on Nausea, Vomiting, and Anxiety after Colonoscopy

Comparison of the Effect of Oral Melatonin and Placebo on Nausea, Vomiting, and Anxiety in Patients Undergoing Anesthesia for Colonoscopy: A Double-Blind Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250904067124N1
Enrollment
64
Registered
2025-09-25
Start date
2024-09-16
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Anxiety in patients undergoing colonoscopy under anesthesia. Generalized anxiety disorder

Interventions

Intervention 1: Intervention group: Intervention group: Patients in this group will receive 3 milligrams of oral melatonin (manufactured by Actoverco Pharmaceutical Company) in the form of a tablet 50

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 55 Years

Inclusion criteria

Inclusion criteria: ASA class I or II Age between 15 to 55 years Non-emergency colonoscopy BMI between 19 to 25 No use of narcotics in the past week No history of thyroid, neuromuscular, kidney, or psychiatric diseases Informed consent for participation Equal number of male and female participants Duration of colonoscopy between 10 to 45 minutes Not enrolled in any other clinical trial

Exclusion criteria

Exclusion criteria: Patients who wish to withdraw from the study Underlying conditions making sedation unsafe Use of benzodiazepines in the past 72 hours Prolonged colonoscopy duration Complications during colonoscopy Need for ileoscopy

Design outcomes

Primary

MeasureTime frame
Level of anxiety before anesthesia in patients undergoing colonoscopy. Timepoint: 50 minutes before anesthesia induction. Method of measurement: Visual Analogue Scale Score for anxiety, recorded by trained staff.

Secondary

MeasureTime frame
Incidence and severity of nausea and vomiting in patients undergoing colonoscopy under general anesthesia, assessed as a secondary outcome of oral melatonin administration. Timepoint: Before anesthesia, during colonoscopy (every 10 minutes), and after colonoscopy in the recovery room (every 15 minutes) until patient reaches an Aldrete score of 8. Method of measurement: Nausea and vomiting will be recorded based on direct clinical observation and patient self-reporting, documented in a standardized patient evaluation form.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSamira Sobhani

Mazandaran University of Medical Sciences

samira.sobhani@mazums.ac.ir+98 11 3336 1700

Outcome results

None listed

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