Phase 4
Completed N=80
Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone
Source: ClinicalTrials.gov NCT01486615 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Change in VAS Anxiety Score Relative to Baseline After Premedication — 0.35; 0.70; 0.65; 0.25 Centimeter
Summary
Background: Benzodiazepine, a common premedicant, suppresses endogenous melatonin levels and thus paradoxically increases episodes of arousal during sleep and thus causes restlessness and hangs over effects. Adding melatonin to it may decrease nocturnal arousal and promote the perception of sound sleep in the perioperative period.
Methods: Eighty patients (ASA 1&2) with anxiety VAS ≥ 2 posted for general anaesthesia will be randomly assigned to receive 0.5 mg alprazolam (Group A), 3 mg melatonin, a combination of 0.5 mg alprazolam and 3 mg melatonin (Group AM), or a similar looking placebo (Group P), approximately 90 minutes before surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in VAS Anxiety Score Relative to Baseline After Premedication |
0.35; 0.70; 0.65; 0.25 | — |
| PRIMARY Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication |
1.15; 1.72; 1.62; 0.82 | — |
| PRIMARY Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication |
1.80; 2.92; 2.35; 0.85 | — |
| SECONDARY Sedation Score at One Hour After Premedication |
0.5; 1; 1; 0 | — |
| SECONDARY Orientation Score |
2; 2; 2; 2 | — |
| SECONDARY Number of Patients With Intact Memory |
13; 4; 5; 14 | — |
| SECONDARY Amount of Propofol Consumption |
79.2; 65.5; 59.0; 75.8 | — |
| SECONDARY Number of Patients With Loss of Memory for Being Transferred to Operating Room. |
1; 5; 4; 0 | — |
Eligibility Criteria
Inclusion Criteria
- (ASA 1&2),
- aging 18 to 65 years
- having anxiety VAS score of more than 2
- posted for general anaesthesia with estimated duration of < 3 hours.
Exclusion Criteria
- patients taking analgesics, sedatives, antiepileptics or antidepressants,
- suffering from obesity (BMI ≥ 28) or neuropsychiatric disease,
- having allergy to the study drugs
Data sourced from ClinicalTrials.gov (NCT01486615). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.