FindTrial
Sign In

To reduce the Pre operative anxiety before various surgical procedures under General Anaesthesia, buy using various drugs like Oral Melatonin, Oral Alprazolam, Combination of both and Placebo

Comparision of Oral Melatonin, Oral alprazolam, combination of both and placebo, premedication for preoperative anxiety in adult patients undergoing surgical procedures under General anaesthesia: A prospective blinded randomized study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031184
Enrollment
144
Registered
2021-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Melatonin, Alprazolam: 4 groups. 1st group receives Oral melatonin(3mg night+3mg morning + placebo). Second group receives Oral Alprazolam(0.25mg night + 0.25 mg morning + placebo. Thir

Sponsors

Nandeeshwara D K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Age: 18years to 60 years 2. ASA 1 and 2 3. Surgery planned under General anaesthesia

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Patient with current/past history of mental illness, neuropsychiatric disease, h/o substance abuse 2. History of known allergy to the study drugs 3. Patients who had taken drugs which may cause sedation in last 12hours, 4. History of intake of antiepileptics, antidepressants or antipsychotics, and immunosuppressive medications

Design outcomes

Primary

MeasureTime frame
Combination of oral melatonin(3mg) +Alprazolam(0.25mg) is better than either drug alone as premedication in reducing anxiety in adult patients undergoing surgery under general anaesthesia.Timepoint: In the preoperative area before shifting to operation theatre—

Secondary

MeasureTime frame
NILTimepoint: NIL—

Countries

India

Contacts

Public ContactDr Samarjit Dey

AIIMS Raipur

drsamar0002@gmail.com8014910806

Outcome results

None listed

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