Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone
This study has been completed.
Sponsor:
B.P. Koirala Institute of Health Sciences
Information provided by (Responsible Party):
Krishna Pokharel, B.P. Koirala Institute of Health Sciences
ClinicalTrials.gov Identifier:
NCT01486615
First received: November 10, 2011
Last updated: September 6, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anxiety |
Drug: meloset (melatonin) Drug: stresnil ( melatonin and alprazolam) Drug: (alprax) alprazolam Drug: placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Premedication With Melatonin and Alprazolam Combination Versus Alprazolam or Melatonin Alone: a Randomized, Double Blind Placebo Controlled Study |
Resource links provided by NLM:
Further study details as provided by B.P. Koirala Institute of Health Sciences:
Primary Outcome Measures:
- Change in VAS Anxiety Score Relative to Baseline After Premedication [ Time Frame: Change from baseline in VAS anxiety score at 15 minutes after premedication ] [ Designated as safety issue: No ]VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
- Change in VAS Anxiety Score Relative to Baseline at 30 Minutes After Premedication [ Time Frame: Changes from baseline in VAS anxiety score at 30 minutes after premedication ] [ Designated as safety issue: No ]VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
- Change in VAS Anxiety Score Relative to Baseline at One Hour After Premedication [ Time Frame: Changes from baseline in VAS anxiety score at one hour after premedication ] [ Designated as safety issue: No ]VAS (Visual Analogue Score) Anxiety Scale is a 10 cm long scale with two sides, the patient side (front) and the clinicians side (back). The extremes of the front are colored as white and black with a gradual darkening of color from white to black. The back is marked in centimeter from 0 to 10 and 0 correlates with white color (no anxiety at all) and 10 correlates to black color (anxiety as bad as ever can be) on the front. As anxiety is worsened, the color is darker and score is more. The maximum score is 10 and minimum 0. The patient is asked to point on the scale according to his anxiety level. The anxiety score is the correlating number on the clinicians side. The more the reduction in anxiety from baseline, the better the outcome.
Secondary Outcome Measures:
- Sedation Score at One Hour After Premedication [ Time Frame: Sedation score at 1 hour after the premedication ] [ Designated as safety issue: No ]Sedation level was assessed with a 5 point scale (0=alert, 1=arouses to voice, 2=arouses with gentle tactile stimulation, 3=arouses with vigorous tactile stimulation, 4=lack of responsiveness). Minimum score is 0 and Maximum is 4. The lesser the score, the better the outcome.
- Orientation Score [ Time Frame: Orientation score at one hour after premedication ] [ Designated as safety issue: No ]Orientation was assessed with a 3 point scale (0=none, 1=orientation in either time or place, 2=orientation in both). Minimum score is 0 and maximum is 2. The lesser the score, the lesser the effect on patients cognition and the better the outcome.
- Number of Patients With Intact Memory [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]Number of patients who recalled or recognized the picture number five shown one hour after premedication. The more the number of patients with intact memory, the better the outcome.
- Amount of Propofol Consumption [ Time Frame: 1 - 2 hour after premedication ] [ Designated as safety issue: No ]Dose of propofol needed for loss of response to verbal command was noted at the time of induction of general anesthesia. The lesser the propofol needed for the loss of response to verbal command, the better the outcome.
- Number of Patients With Loss of Memory for Being Transferred to Operating Room. [ Time Frame: 24 hour after surgery ] [ Designated as safety issue: No ]Patients were asked whether they recalled the event of being transferred to the operating room before anaesthesia. The lesser the number of patients with amnesia, the better the outcome.
| Enrollment: | 80 |
| Study Start Date: | October 2011 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Melatonin
Premedication with 3 mg melatonin (Meloset) tablet orally 1-2 hour prior to anesthesia
|
Drug: meloset (melatonin)
3 mg melatonin tablet 1-2 hour prior surgery
|
|
Placebo Comparator: melatonin and alprazolam premedication
Premedication with 3 mg melatonin and 0.5 mg alprazolam (Stresnil) tablet orally 1-2 hrs prior to anesthesia
|
Drug: stresnil ( melatonin and alprazolam)
3 mg melatonin and 0.5 mg alprazolam 1-2 hr before anesthesia
|
|
Placebo Comparator: alprazolam premedication
Premedication with 0.5 mg alprazolam (Alprax) tablet orally 1-2 hr prior to anesthesia
|
Drug: (alprax) alprazolam
0.5 mg alprazolam
|
|
Active Comparator: placebo premedication
Premedication with a similar looking placebo tablet orally 1-2 hr prior to anesthesia
|
Drug: placebo
similar looking placebo tablet
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486615
Locations
| Nepal | |
| B. P. Koirala Institute of Health Sciences | |
| Dharan, Koshi, Nepal, 56700 | |
| Dr Krishna Pokharel | |
| Dharan, Koshi, Nepal, 56700 | |
Sponsors and Collaborators
B.P. Koirala Institute of Health Sciences
Investigators
| Principal Investigator: | Krishna Pokharel, MD | B.P. Koirala Institute of Health Sciences |
| Study Director: | Balkrishna Bhattarai, MD | B.P. Koirala Institute of Health Sciences |
More Information
Additional Information:
Publications:
| Responsible Party: | Krishna Pokharel, Associate Professor, B.P. Koirala Institute of Health Sciences |
| ClinicalTrials.gov Identifier: | NCT01486615 History of Changes |
| Other Study ID Numbers: | 2/18 (Acd. 796/067/068) |
| Study First Received: | November 10, 2011 |
| Results First Received: | May 20, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | Nepal: Health Research Council |
Keywords provided by B.P. Koirala Institute of Health Sciences:
|
premedication premedicants preoperative anxiety melatonin alprazolam |
Additional relevant MeSH terms:
|
Anxiety Disorders Mental Disorders Alprazolam Azaperone Melatonin Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents |
Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antipsychotic Agents Dopamine Antagonists Dopamine Agents Antioxidants Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013